Label: BABY NIGHTTIME ORAL PAIN RELIEF- arnica montana, tribasic calcium phosphate, matricaria chamomilla, silicon dioxide, magnesium phosphate, dibasic trihydrate, ferrosoferric phosphate, arabica coffee bean and oyster shell calcium carbonate, crude tablet

  • NDC Code(s): 54973-3324-1, 54973-3324-4
  • Packager: Hyland' Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated January 17, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • Drug Facts

    Active ingredientsPurpose
    Arnica Montana 30X HPUSsore, sensitive or swelling gums
    Calcarea Carbonica 12X HPUSteething, sore, sensitive or swelling gums
    Calcarea Phosphorica 12X HPUSteething, sensitive, swelling gums, oral pain
    Chamomilla 12X HPUSsore, sensitive or swelling gums
    Coffea Cruda 6X HPUSoral pain, irritability
    Ferrum Phosphoricum 12X HPUSoral discomfort, swelling gums
    Magnesia Phosphorica 12X HPUSoral pain, occasional sleeplessness
    Silicea 12X HPUSoral pain at night, occasional sleeplessness

    "HPUS" is the Homeopathic Pharmacopoeia of the United States.

  • Uses

    ■ Helps temporarily relieve symptoms of oral pain or discomfort in children, including:
    ■ teething ■ gum sensitivity ■ swelling or soreness of gums
    ■ irritability ■ occasional sleeplessness

  • Warnings

    Stop use and ask a doctor if

    ■ symptoms persist for more than 72 hours or worsen.

    ■ swelling increases; nasal congestion, rash or fever is present or develops.

    ■ irritation, pain or redness persists or worsens.

    Keep out of reach of children

  • Directions

    ■ Use as directed.

    Children under
    6 months     		At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours as needed. If symptoms persist,
    2 tablets every 4 hours during the night until relieved.
    Children 6 months
    to under 3 years     		At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours as needed. If symptoms persist,
    3 tablets every 4 hours during the night until relieved

  • Inactive ingredients

    Acacia Gum, Lactose.

  • Questions?

    www.hylands.com or care@hylands.com

  • *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

  • DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

  • PURPOSE

    Helps temporarily relieve symptoms of oral pain or discomfort in children, including: teething, gum sensitivity, swelling or soreness of gums, irritability, occasional sleeplessness.

  • Principal Display Panel

    Hyland's

    NATURALS

    •baby•

    Oral Pain

    Relief*

    NIGHTTIME

    NO BENZOCAINE,

    DYES or PARABENS

    Sleeplessness

    Teething Pain

    Oral Discomfort

    Irritability

    Swelling

    0+ Months

    125

    QUICK-DISSOLVING TABLETS

    HOMEOPATHIC

    Carton

  • INGREDIENTS AND APPEARANCE
    BABY NIGHTTIME ORAL PAIN RELIEF 
    arnica montana, tribasic calcium phosphate, matricaria chamomilla, silicon dioxide, magnesium phosphate, dibasic trihydrate, ferrosoferric phosphate, arabica coffee bean and oyster shell calcium carbonate, crude tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3324
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]  in 1 g
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE12 [hp_X]  in 1 g
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA12 [hp_X]  in 1 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 g
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_X]  in 1 g
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE12 [hp_X]  in 1 g
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 1 g
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE12 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    ACACIA (UNII: 5C5403N26O)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3324-11 in 1 CARTON08/17/2017
    11 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3324-46 g in 1 PACKET; Type 0: Not a Combination Product08/17/201712/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/17/2017
    Labeler - Hyland' Inc. (008316655)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!