Home NDC 21130-224 Acetaminophen and Diphenhydramine hydrochloride
Product NDC 21130-224
11-digit product format 211300224
Labeler code 21130
Product ID 21130-224_0b35e6d7-d8ed-de5d-e063-6394a90a1777
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Diphenhydramine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Better Living Brands, LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-11-18
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 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 21130-224-18 Acetaminophen and Diphenhydramine hydrochloride 80 in 1 BOTTLE TABLET 80 2 21130-224-18 Acetaminophen and Diphenhydramine hydrochloride 1 in 1 CARTON TABLET 1 2 21130-224-73 Acetaminophen and Diphenhydramine hydrochloride 20 in 1 BOTTLE TABLET 20 2 21130-224-73 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 21130-224 ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET [BETTER LIVING BRANDS, LLC] 2 Current NDC, 4 package rows 20231129_fc07d516-9ffe-9989-e053-6294a90ae1a5.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 Sample Exclude flag Status 21130-224-18 21130022418 1 BOTTLE in 1 CARTON (21130-224-18) / 80 TABLET in 1 BOTTLE 1 bottle 2023-11-18 No No Current 21130-224-73 21130022473 1 BOTTLE in 1 CARTON (21130-224-73) / 20 TABLET in 1 BOTTLE 1 bottle 2023-11-18 No No Current