acetaminophen, diphenhydramine hydrochloride

Generic: acetaminophen, diphenhydramine hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen, diphenhydramine hydrochloride
Generic Name acetaminophen, diphenhydramine hydrochloride
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1, diphenhydramine hydrochloride 25 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6731
Product ID 0904-6731_102f4c28-a2f1-3e69-e063-6394a90af867
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2018-12-26

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046731
Hyphenated Format 0904-6731

Supplemental Identifiers

RxCUI
1092189
UNII
362O9ITL9D TC2D6JAD40

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name acetaminophen, diphenhydramine hydrochloride (source: ndc)
Generic Name acetaminophen, diphenhydramine hydrochloride (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 25 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0904-6731-51) / 50 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

0904-6731-51 1 BOTTLE in 1 CARTON (0904-6731-51) / 50 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

acetaminophen (500 mg/1) diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Acetaminophen, Diphenhydramine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "102f4c28-a2f1-3e69-e063-6394a90af867", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["1092189"], "spl_set_id": ["786dbcd5-f5c2-4491-e053-2991aa0a3437"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0904-6731-51)  / 50 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0904-6731-51", "marketing_start_date": "20181226"}], "brand_name": "Acetaminophen, Diphenhydramine Hydrochloride", "product_id": "0904-6731_102f4c28-a2f1-3e69-e063-6394a90af867", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0904-6731", "generic_name": "Acetaminophen, Diphenhydramine Hydrochloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen, Diphenhydramine Hydrochloride", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20181226", "listing_expiration_date": "20261231"}