acetaminophen pm

Generic: acetaminophen and diphenhydramine hydrochloride

Labeler: fsa store inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen pm
Generic Name acetaminophen and diphenhydramine hydrochloride
Labeler fsa store inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
FSA STORE INC.

Identifiers & Regulatory

Product NDC 81522-095
Product ID 81522-095_2499e0c3-bbc3-58aa-e063-6294a90a4ed5
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2023-05-02

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 81522095
Hyphenated Format 81522-095

Supplemental Identifiers

RxCUI
1092189
UPC
0099581912055
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 pm (source: ndc)
Generic Name acetaminophen and 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, PLASTIC in 1 CARTON (81522-095-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

81522-095-03 1 BOTTLE, PLASTIC in 1 CARTON (81522-095-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC

Ingredients (2)

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

Linked Drug Pages (1)

Acetaminophen PM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2499e0c3-bbc3-58aa-e063-6294a90a4ed5", "openfda": {"upc": ["0099581912055"], "unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["1092189"], "spl_set_id": ["f4322f34-ac19-371e-e053-2a95a90ac864"], "manufacturer_name": ["FSA STORE INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (81522-095-03)  / 100 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "81522-095-03", "marketing_start_date": "20230502"}], "brand_name": "Acetaminophen PM", "product_id": "81522-095_2499e0c3-bbc3-58aa-e063-6294a90a4ed5", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "81522-095", "generic_name": "Acetaminophen and Diphenhydramine Hydrochloride", "labeler_name": "FSA STORE INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen PM", "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": "20230502", "listing_expiration_date": "20261231"}