Home NDC 58602-760 Acetaminophen and Diphenhydramine hydrochloride
Product NDC 58602-760
11-digit product format 586020760
Labeler code 58602
Product ID 58602-760_0b448607-8f69-f9b8-e063-6394a90ae841
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Diphenhydramine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Aurohealth LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-01-05
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 500; 25 mg/1; mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Acetaminophen and Diphenhydramine hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup TC2D6JAD40 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58602-760-14 Acetaminophen and Diphenhydramine hydrochloride 1 in 1 CARTON TABLET 1 2 58602-760-14 Acetaminophen and Diphenhydramine hydrochloride 50 in 1 BOTTLE TABLET 50 2 58602-760-73 Acetaminophen and Diphenhydramine hydrochloride 20 in 1 BOTTLE TABLET 20 2 58602-760-73 Acetaminophen and Diphenhydramine hydrochloride 1 in 1 CARTON TABLET 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58602-760 ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET [AUROHEALTH LLC] 2 Current NDC, Legacy NDC, 4 package rows 20231130_3ba51b52-7ae6-4335-b178-1b7b6ef36227.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 79 · 1,579 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58602-760-14 58602076014 1 BOTTLE in 1 CARTON (58602-760-14) / 50 TABLET in 1 BOTTLE 1 bottle 2021-01-05 0000-00-00 No No Current 58602-760-73 58602076073 1 BOTTLE in 1 CARTON (58602-760-73) / 20 TABLET in 1 BOTTLE 1 bottle 2021-01-05 0000-00-00 No No Current