Home NDC 68016-654 Acetaminophen Diphenhydramine HCl
Product NDC 68016-654
11-digit product format 680160654
Labeler code 68016
Product ID 68016-654_47f839b9-ac8b-161c-e054-00144ff8d46c
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen Diphenhydramine HCl
Dosage form TABLET
Route ORAL
Labeler Chain Drug Consortium,LLC
Application part343
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2016-02-25
Substance ACETAMINOPHEN; DIPHENHYDRAMINE
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 Diphenhydramine HCl
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DIPHENHYDRAMINE 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 8GTS82S83M 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 68016-654-05 Acetaminophen Diphenhydramine HCl 50 in 1 BOTTLE TABLET 50 1 68016-654-10 Acetaminophen Diphenhydramine HCl 100 in 1 BOTTLE TABLET 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-654 ACETAMINOPHEN DIPHENHYDRAMINE HCL TABLET [CHAIN DRUG CONSORTIUM,LLC] 1 Current NDC, Legacy NDC, 2 package rows 20170214_47f839b9-ac8a-161c-e054-00144ff8d46c.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 1 · 1 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 68016-654-05 68016065405 50 TABLET in 1 BOTTLE (68016-654-05) 50 tablet 2016-02-25 0000-00-00 No No Current 68016-654-10 68016065410 100 TABLET in 1 BOTTLE (68016-654-10) 100 tablet 2016-02-25 0000-00-00 No No Current