Home NDC 70000-0411 Acetaminophen, Diphenhydramine Hydrochloride
Product NDC 70000-0411
11-digit product format 700000411
Labeler code 70000
Product ID 70000-0411_4bbe57b4-c0c6-c37f-e063-6294a90a7dd7
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler LEADER/ Cardinal Health 110, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-11-29
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 2027-12-31
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, Diphenhydramine Hydrochloride
Listing expiration 2027-12-31 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1092189 Internal RxNorm 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 70000-0411-1 Acetaminophen, Diphenhydramine Hydrochloride 1 in 1 CARTON TABLET, FILM COATED 1 7 70000-0411-1 Acetaminophen, Diphenhydramine Hydrochloride 24 in 1 BOTTLE TABLET, FILM COATED 24 7 70000-0411-2 Acetaminophen, Diphenhydramine Hydrochloride 50 in 1 BOTTLE TABLET, FILM COATED 50 7 70000-0411-3 Acetaminophen, Diphenhydramine Hydrochloride 1 in 1 CARTON TABLET, FILM COATED 1 7 70000-0411-3 Acetaminophen, Diphenhydramine Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0411 ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [LEADER/ CARDINAL HEALTH 110, INC.] 6 Current NDC, Legacy NDC, 5 package rows 20250212_7be4d67e-1af9-f059-e053-2991aa0a382e.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 83 · 1,657 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70000-0411-1 70000041101 1 BOTTLE in 1 CARTON (70000-0411-1) / 24 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2018-12-10 0000-00-00 No No Current 70000-0411-2 70000041102 50 TABLET, FILM COATED in 1 BOTTLE (70000-0411-2) 2018-11-29 0000-00-00 No No Current 70000-0411-3 70000041103 1 BOTTLE in 1 CARTON (70000-0411-3) / 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2018-12-10 0000-00-00 No No Current