acetaminophen and diphenhydramine hydrochloride

Generic: acetaminophen and diphenhydramine hydrochloride

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen and diphenhydramine hydrochloride
Generic Name acetaminophen and diphenhydramine hydrochloride
Labeler aurohealth llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-760
Product ID 58602-760_0b448607-8f69-f9b8-e063-6394a90ae841
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2021-01-05

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 58602760
Hyphenated Format 58602-760

Supplemental Identifiers

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 and diphenhydramine hydrochloride (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 in 1 CARTON (58602-760-14) / 50 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-760-73) / 20 TABLET in 1 BOTTLE
source: ndc

Packages (2)

58602-760-14 1 BOTTLE in 1 CARTON (58602-760-14) / 50 TABLET in 1 BOTTLE 58602-760-73 1 BOTTLE in 1 CARTON (58602-760-73) / 20 TABLET in 1 BOTTLE

Ingredients (2)

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

Linked Drug Pages (1)

Acetaminophen and Diphenhydramine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0b448607-8f69-f9b8-e063-6394a90ae841", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40"], "spl_set_id": ["3ba51b52-7ae6-4335-b178-1b7b6ef36227"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-760-14)  / 50 TABLET in 1 BOTTLE", "package_ndc": "58602-760-14", "marketing_start_date": "20210105"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-760-73)  / 20 TABLET in 1 BOTTLE", "package_ndc": "58602-760-73", "marketing_start_date": "20210105"}], "brand_name": "Acetaminophen and Diphenhydramine hydrochloride", "product_id": "58602-760_0b448607-8f69-f9b8-e063-6394a90ae841", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "58602-760", "generic_name": "Acetaminophen and Diphenhydramine hydrochloride", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen and 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": "20210105", "listing_expiration_date": "20261231"}