Home NDC 21130-661 Acetaminophen and Diphenhydramine HCL
Product NDC 21130-661
11-digit product format 211300661
Labeler code 21130
Product ID 21130-661_4650a298-b556-8c7e-e063-6394a90a01db
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Diphenhydramine HCL
Dosage form TABLET
Route ORAL
Labeler SAFEWAY
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-30
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 Additional Listing Data#
Finished product Yes
Brand name base Acetaminophen and 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 21130-661-10 Acetaminophen and Diphenhydramine HCL 100 in 1 BOTTLE TABLET 100 7 21130-661-20 Acetaminophen and Diphenhydramine HCL 200 in 1 BOTTLE TABLET 200 7 21130-661-24 Acetaminophen and Diphenhydramine HCL 24 in 1 BOTTLE TABLET 24 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21130-661 ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLET [SAFEWAY] 6 Current NDC, 3 package rows 20241218_f18c1aa2-5f8b-5458-e053-2995a90ab947.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 84 · 1,678 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 21130-661-10 21130066110 100 TABLET in 1 BOTTLE (21130-661-10) 100 tablet 2023-06-30 No No Current 21130-661-20 21130066120 200 TABLET in 1 BOTTLE (21130-661-20) 200 tablet 2023-06-30 No No Current 21130-661-24 21130066124 24 TABLET in 1 BOTTLE (21130-661-24) 24 tablet 2023-06-30 No No Current