News: DailyMed Announcements

NEWS FROM THE YEAR

2021 2020 2019 2017 2016 2015 2014

• RxImage API to be Discontinued

  Posted: September 15, 2021

  The RxImage API will cease operation on December 31, 2021. All RxImage data are available for download from here .
  DailyMed will be removing pill images provided by the RxImage API on October 31, 2021. Pill images submitted by labelers with their structured product labeling will remain on DailyMed.
  
  

• Pfizer received FDA BLA license on 8/23/2021 for its COVID-19 vaccine

  Posted: September 13, 2021

  Pfizer received FDA BLA license on 8/23/2021 for its COVID-19 vaccine for use in individuals 16 and older (COMIRNATY). At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 2 new NDCs (0069-1000-03, 0069-1000-02) and images of labels with the new tradename.

  
  

  At present, Pfizer does not plan to produce any product with these new NDCs and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution. As such, the CDC, AMA, and drug compendia may not publish these new codes until Pfizer has determined when the product will be produced with the BLA labels.

• DailyMed in the Cloud

  Posted: September 02, 2020
  

  DailyMed is migrating to cloud services on September 14, 2020. The look and feel of DailyMed will not change in the cloud. Aside from improved performance, users should not expect any changes to their DailyMed experience following the move to the cloud.

  As previously announced, DailyMed will be switching from static IP addresses to dynamic IP addresses in the cloud. For users with a specific interest in the dynamic IP addresses, you can preview a beta version of DailyMed in the cloud here: https://beta-dailymed.nlm.nih.gov/dailymed/.

  If you have any questions, please contact the NLM Support Center.

• Pillbox Retiring

  Posted: August 17, 2020
  

  Pillbox is being retired in January 2021, for further information please see the NLM Technical Bulletin. DailyMed will be removing associated links to Pillbox currently labeled as "TABLET/CAPSULE ID TOOL" in the "MORE WAYS TO SEARCH" section.

• DailyMed Testing Static IP Removal

  Posted: March 23, 2020
  

  
  Now live - 04/06/2020: DailyMed is using dynamic IP addresses.
  
  DailyMed is migrating to cloud services later this year and will be moving away from static IP addresses during this process. In preparation of this change, DailyMed will temporarily remove its static IP addresses and move to dynamic IP addresses for a week starting on 04/06/2020 and ending on 04/10/2020.

  During this period, if you encounter any issues please let us know by contacting the NLM Support Center for further assistance.
  If you know you will be impacted by this change, or you have any other concerns or issues, please contact customer support.

• Information About Regulatory Changes for Certain Biological Product Medications Beginning on March 23, 2020

  Posted: March 23, 2020
  

  On March 23, 2020, the Biologics Price Competition and Innovation Act of 2009 requires that an approved application for a “biological product” under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) shall be deemed to be a license for the biological product (i.e., an approved Biologics License Application (BLA)) under section 351 of the Public Health Service Act (PHS Act). FDA has assigned...

• TLS1.1 Protocol Disabled as of December 30, 2019

  Posted: December 17, 2019
  

  To be compliant with NIH HTTPS standards, NLM across all its public websites is disabling TLS1.1 protocol by December 30, 2019. If you have any questions please let us know by contacting the NLM Support Center.

• NLM Flagging SPLs Associated With Inactivated NDCs

  Posted: November 27, 2019
  

  In October 2019, NLM added an Indexing File (FDA-INITIATED COMPLIANCE ACTION - DRUG LISTING INACTIVATION) that includes NDCs from outdated or uncertified FDA listing records. NLM is now flagging SPLs associated with inactivated NDCs in DailyMed. Such SPLs will have a “Contains inactivated NDC Code(s)” link above the NDCs at the top of an SPL. Clicking on the link will display all the NDCs associated with the labeling, with the inactivated NDCs tagged. This tag will be removed after the manufacture takes action to be in compliance with the FDA.

  A new link “View all NDC Code(s)” has also been added on the side and bottom, under More Info For This Drug.

• FDA Initiated Compliance Action Indexing File Now Available

  Posted: October 30, 2019
  

  NLM has added a new zip file from the FDA that contains SPLs with document type as “FDA-INITIATED COMPLIANCE ACTION DRUG REGISTRATION AND LISTING”. For further information including FDA contact information please see the notice.

• New Features for Accessing Label Archives and Medication Guides

  Posted: September 19, 2019
  

  Users can now search the label archives with a Set ID, in addition to the drug name searching that was already available. The Set ID uniquely identifies a label. Searching by Set ID in the label archives will retrieve all versions of the...

• Outdated Drug Listing Data

  Posted: August 29, 2019
  

  The Food and Drug Administration (FDA) announced that it will begin inactivating outdated drug listing data starting 30 days after publication of the Federal Register Notice (FRN). For further information including FDA contact information please see the notice.

• Drug Listing Certification

  Posted: December 19, 2017
  

  The U.S. Food and Drug Administration is reminding the pharmaceutical industry of the December 31, 2017, deadline to update or certify their drug listings with FDA. This applies to drug listings that were not initially listed or updated during the current calendar year. This is the first deadline of the annual certification requirement under Part 207 of Title 21 of the Code of Federal Regulations.

  Companies must submit this information to FDA in electronic format. They may make a blanket "no changes" certification to indicate that their listing information is up to date in FDA's database. Information about how to certify or submit updates is available at Electronic Drug Registration and Listing System.

  It is important for companies to update or certify their listings to ensure that FDA has an accurate list of marketed drugs in the National Drug Code directory. Failure to submit an update or certification by the December 31, 2017, deadline may result in FDA action, including removing the product from the NDC directory. Companies that need further assistance to submit the required information by the December 31, 2017, deadline should contact edrls@fda.hhs.gov.

• Searching by Unique Ingredient Identifier Now Available

  Posted: October 19, 2017
  

  Users can now search DailyMed by unique ingredient identifier (UNII) for an active ingredient and an active moiety. Instead of relying on drug or chemical names, which vary across countries and regions, searching by UNII allows DailyMed to retrieve drug product records by ingredient using a common global identifier.

  A UNII is a globally used, non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. The joint Food and Drug Administration (FDA)/ United States Pharmacopeia (USP) Substance Registration System (SRS) assigns a UNII to a substance when enough information is collected.

  To illustrate, a common active ingredient in anti-allergy medications is diphenhydramine hydrochloride with UNII TC2D6JAD40. Searching "TC2D6JAD40" in DailyMed retrieves over 1500 drug product records. Diphenhydramine with UNII 8GTS82S83M is the active moiety of diphenhydramine hydrochloride. Searching "8GTS82S83M" retrieves over 1600 records as of Oct 2017.

• Drug Listing Certification is Coming

  Posted: October 06, 2017
  

  Slides and recordings from the FDA's October 5, 2017 meeting titled Electronic Drug Registration & Listing Using CDER Direct are now available.

  https://sbiaevents.com/edrls-2017/

• Drug Listing Certification is Coming

  Posted: September 26, 2017
  

  The FDA is holding a free meeting on October 5, 2017 titled Electronic Drug Registration & Listing Using CDER Direct. This in-person and on-line event is intended to educate and assist all drug firms with the registration and listing process. Each session will focus on a specific submission (Establishment Registration, Product Listing, Listing Recertification, Labeler Code Requests, 503B Product Reporting) and walk through the creation and submission of each using FDA's free authoring tool: CDER Direct.

  Additionally, for those who attend in person, experts and helpdesk technicians will be on hand to answer regulatory and technical questions, and assist with submissions.

  https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/cder-sbia-extended-webinar-electronic-drug-registration-listing-using-cder-direct-october-5-2017

• DailyMed/RxNorm Jamboree Workshop 2017

  Posted: July 19, 2017
  

  NLM's 5th annual Jamboree will take place Tuesday, September 19, 2017, in the Lister Hill Auditorium at NLM on the NIH campus in Bethesda, MD. Speakers from the Federal government, industry, pharmacy standards groups, and others will present. The emphasis as always is on practical and novel ways to use and understand this free drug information, which is produced and consumed by a number of Federal agencies.

  Registration is required, and seating is limited. While the proceedings will be webcast and archived, in-person attendance offers greater opportunity to exchange ideas, questions, and insights with your peers. Please find registration and agenda information here: https://www.nlm.nih.gov/mesh/Jamboree/2017.html

• Searching by Application Number Now Available

  Posted: June 23, 2017
  

  Users can now search DailyMed by drug product application number. The application number is assigned by FDA staff to each application for approval to market a drug in the United States. There are currently application numbers for five types of application included in DailyMed:

  • New Drug Application (NDA)
  • Abbreviated New Drug Application (ANDA)
  • Biologic License Application (BLA)
  • New Animal Drug Application (NADA)
  • Abbreviated New Animal Drug Application (ANADA)

  When searching by application number, users must prepend the application type to the application number to retrieve drug product records. For example, searching by 'NDA208603' will retrieve the record for abuse-deterrent Arymo morphine sulfate oral tablets, and searching by 'ANADA200306' will retrieve a set of results for oxytetracycline injectable products for animals.

• DailyMed/RxNorm Jamboree Workshop 2017

  Posted: April 13, 2017
  NLM's 5th annual Jamboree will take place Tuesday, September 19, 2017, in the Lister Hill Auditorium at NLM on the NIH campus in Bethesda, MD. We will add a list of speakers and a registration page by late June.

• DailyMed/RxNorm Jamboree Workshop 2016 Archive

  Posted: October 3, 2016
  NLM's 4th annual Jamboree took place Tuesday, September 27, 2016, in the Lister Hill Auditorium at NLM on the NIH campus in Bethesda, MD. Please visit https://www.nlm.nih.gov/mesh/Jamboree/2016.html for an archived recording of the event, instructions on how to obtain presentation slides, and to provide feedback.

• Update: 2016 DailyMed/RxNorm Jamboree Workshop scheduled for September 27

  Posted: September 13, 2016
  Updated Agenda: https://www.nlm.nih.gov/mesh/Jamboree/agenda2016.pdf
  NLM's 4th annual Jamboree will take place Tuesday, September 27, 2016, in the Lister Hill Auditorium at NLM on the NIH campus in Bethesda, MD. Speakers from the Federal government, industry, pharmacy standards groups, and others will present. The emphasis as always is on practical and novel ways to use and understand this free drug information, which is produced and consumed by a number of Federal agencies.
  
  Registration is required, and seating is limited. While the proceedings will be webcast and archived, in-person attendance offers greater opportunity to exchange ideas, questions, and insights with your peers. Please find registration and agenda information here: https://www.nlm.nih.gov/mesh/Jamboree/2016.html

• 2016 DailyMed/RxNorm Jamboree Workshop scheduled for September 27

  Posted: July 5, 2016
  NLM's 4th annual Jamboree will take place Tuesday, September 27, 2016, in the Lister Hill Auditorium at NLM on the NIH campus in Bethesda, MD. Speakers from the Federal government, industry, pharmacy standards groups, and others will present. The emphasis as always is on practical and novel ways to use and understand this free drug information, which is produced and consumed by a number of Federal agencies.
  
  Registration is required, and seating is limited. While the proceedings will be webcast and archived, in-person attendance offers greater opportunity to exchange ideas, questions, and insights with your peers. Please find registration and agenda information here: https://www.nlm.nih.gov/mesh/Jamboree/2016.html

• DailyMed Now Served Over HTTPS Only

  Posted: March 7, 2016
  DailyMed has been updated to serve all content over HTTPS only.
  
  The base URL for the web application is: https://dailymed.nlm.nih.gov/
  
  The base URL for the web service is: https://dailymed.nlm.nih.gov/dailymed/services/

• DailyMed changing to HTTPS

  Posted: December 1, 2015
  DailyMed is changing its base URLs from HTTP to HTTPS.
  
  The new base URL for the web application is: https://dailymed.nlm.nih.gov/
  
  The new base URL for the web service is: https://dailymed.nlm.nih.gov/dailymed/services/
  
  If you are using our web services with HTTP, please update your code to use HTTPS by January 31, 2016. After that date, HTTP access will be disabled.

• Filtering By Published Date Added to Web Services

  Posted: October 8, 2015
  Users can now filter /spls web service calls by the date a drug label was published. Users can specify a date (YYYY-MM-DD) with the published_date parameter to retrieve results for active labels published on that date. Additionally, users can take advantage of the published_date_comparison parameter in conjunction with the published_date parameter to retrieve results for labels published before or after specific dates.

• "Product Concept" and "Biologic or Drug Substance" Indexing Files Added

  Posted: September 25, 2015
  The SPL "Product Concept" and "Biologic or Drug Substance" Indexing Files have been added to the DailyMed Indexing Files page.

• 2015 DailyMed/RxNorm Jamboree Workshop scheduled for September 24

  Posted: July 21, 2015
  NLM's 3rd annual Jamboree will take place September 24, 2015 at Lister Hill Auditorium on the NLM campus in Bethesda, MD. Speakers from the Federal government (ONC, CMS, NLM), industry (First Data Bank, Surescripts), academia (University of New Mexico, University of Pittsburgh), pharmacy standards groups (American Society of Health Systems Pharmacists (ASHP), United States Pharmacopeia (USP), and others will present.
  The emphasis, as always, is on practical and novel ways to use and understand this free drug information, which is produced and consumed by a number of Federal agencies.

• Number of Search Results Per Page Increased & Drug Label Section Snippets Added

  Posted: May 14, 2015
  When searching on DailyMed, users will now see 20 search results per page. Additionally, users have the option of increasing the number of search results per page to 50, 100, or 200.
  Users will now see snippets from the sections when viewing a drug label. These snippets allow users to preview the content for each section without having to expand the section first.

• DailyMed Interface Updated for Quicker and Easier Searching & UNIIs, Inactive Ingredients, and Active Moieties Added to DailyMed's Advanced Search Options

  Posted: April 15, 2015
  Desktop and tablet users can now find the DailyMed search box displayed at the top of DailyMed's pages. This interface change makes it much quicker and easier to search for drug labels on DailyMed.
  DailyMed's Advanced Search users now have the option to search on more fields including "UNII Code", "Inactive Ingredients", and "Active Moiety".

• DailyMed Adds Ingredient UNIIs and Relevancy Sorting for Search Results

  Posted: March 31, 2015
  DailyMed now includes FDA unique ingredient identifiers (UNII) in the 'Ingredients and Appearance' section of all labels.
  The default display for DailyMed search results is now 'Sort By Relevance'.

• RxNorm Prescribable Names Added to DailyMed

  Posted: March 18, 2015
  DailyMed now includes an additional set of drug names from RxNorm, a drug terminology produced by NLM. You can now find RxNorm prescribable names (PSN), which are user-friendly and display-friendly synonyms for drugs, associated with many drug product labels.

• DailyMed Site Update

  Posted: September 26, 2014
  On September 18, 2014, NLM launched a newly redesigned DailyMed Web site. The update includes a responsive design and many changes that improve usability and navigation.

• SPL/DailyMed Jamboree 2014 Workshop

  Posted: July 1, 2014
  NLM is hosting a public workshop about using DailyMed data. The Jamboree will take place on Thursday, September 18, 2014.

• DailyMed Web Services Update

  Posted: February 2, 2014
  The DailyMed API has been updated to Version 2, which includes new resources and provides improved access to the DailyMed data.