allergy and headache

Generic: acetaminophen, diphenhydramine hcl

Labeler: cvs woonsocket prescription center, incorporated
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name allergy and headache
Generic Name acetaminophen, diphenhydramine hcl
Labeler cvs woonsocket prescription center, incorporated
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, diphenhydramine hydrochloride 25 mg/1

Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Identifiers & Regulatory

Product NDC 51316-561
Product ID 51316-561_b86ae17a-32e7-4fbd-a602-88e334450b98
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-12-09

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 51316561
Hyphenated Format 51316-561

Supplemental Identifiers

RxCUI
2729789
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 allergy and headache (source: ndc)
Generic Name acetaminophen, diphenhydramine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 25 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (51316-561-09) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

51316-561-09 2 BLISTER PACK in 1 CARTON (51316-561-09) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (2)

acetaminophen (325 mg/1) diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Allergy and Headache ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b86ae17a-32e7-4fbd-a602-88e334450b98", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["2729789"], "spl_set_id": ["dc249163-26dd-42ca-b423-2f16299f2d65"], "manufacturer_name": ["CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (51316-561-09)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "51316-561-09", "marketing_start_date": "20251209"}], "brand_name": "Allergy and Headache", "product_id": "51316-561_b86ae17a-32e7-4fbd-a602-88e334450b98", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "51316-561", "generic_name": "Acetaminophen, Diphenhydramine HCl", "labeler_name": "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Allergy and Headache", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251209", "listing_expiration_date": "20261231"}