Label: BANOPHEN- diphenhydramine hcl tablet, film coated
- NDC Code(s): 83112-555-59
- Packager: Health Department, Oklahoma State
- This is a repackaged label.
- Source NDC Code(s): 0904-5551
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated January 29, 2025
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INGREDIENTS AND APPEARANCE
BANOPHEN
diphenhydramine hcl tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:83112-555(NDC:0904-5551) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Product Characteristics Color pink Score no score Shape OVAL Size 11mm Flavor Imprint Code 44;329 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83112-555-59 1 in 1 PACKET; Type 0: Not a Combination Product 01/31/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/31/2025 Labeler - Health Department, Oklahoma State (143673015) Registrant - Health Department, Oklahoma State (143673015) Establishment Name Address ID/FEI Business Operations Health Department, Oklahoma State 143673015 repack(83112-555)

