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 72 of 79 · 1,576 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Excedrin Tension Headache ACETAMINOPHEN, CAFFEINE Haleon US Holdings LLC 12c074d1-81ac-47d2-8747-b018cda0058a 2024-03-13 Warnings Exact identifier application number: M013 Menstrual Complete ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE Strive Pharmaceuticals Inc. 78c12459-3b27-4ed0-943d-520794eb438d 2024-03-07 Warnings Exact identifier application number: M013 Pain Reliever fever Reducer Extra Strength ACETAMINOPHEN CVS Pharmacy 7b5263ad-01b7-4fc5-9384-4da8efe89e35 2024-03-06 Warnings Exact identifier application number: M013 Excedrin Extra Strength Geltabs ACETAMINOPHEN, ASPRIN, CAFFEINE Haleon US Holdings LLC 11a8439b-0159-4351-b0f5-fe7fad6a33c0 2024-03-05 Warnings Exact identifier application number: M013 Winco Foods Effervescent Pain Relief ASPIRIN Winco Foods, LLC 128afdd7-a9d1-8957-e063-6294a90af569 2024-03-05 Warnings Exact identifier application number: M013 Aspirin Low Dose Safety Coated ASPIRIN Care One (Retail Business Services, LLC.) 6659e103-fa03-4de0-af42-d2fbd548a87c 2024-03-05 Warnings Exact identifier application number: M013 Dolex Children Pain and Fever ACETAMINOPHEN Pharmadel LLC f9158463-aeb1-5de0-e053-6294a90a748b 2024-03-04 Warnings Exact identifier application number: M013 SEDALMEX FORTE ACETAMINOPHEN, ASPIRIN, CAFFEINE Belmora LLC 33b3508e-4caa-4d05-9b15-cb82a2ee2d4d 2024-02-28 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN AMERISOURCE BERGEN 2b923a97-836c-4dac-a8c0-3047a35fb62e 2024-02-23 Warnings Exact identifier application number: M013 Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL BJWC (Berkley & Jensen / BJ's) b20a08f3-c9c0-4bd9-8ce0-acb932b5bb86 2024-02-22 Warnings Exact identifier application number: M013 M-PAP ACETAMINOPHEN Bryant Ranch Prepack 31a41976-7f65-42d7-acf5-de9c2c5ca58e 2024-02-20 Warnings Exact identifier application number: M013 Publix Fast Relief Effervescent - Original Flavor ASPIRIN PUBLIX SUPER MARKETS INC. 0a342f72-45fd-3e12-e063-6394a90ae33e 2024-02-16 Warnings Exact identifier application number: M013 Equaline Effervescent Pain Reliever ASPIRIN UNITED NATURAL FOODS, INC. DBA UNFI 0761299a-e913-7665-e063-6394a90a6003 2024-02-16 Warnings Exact identifier application number: M013 TopCare Effervescent Pain Relief ASPIRIN TOPCO ASSOCIATES LLC 075f36e1-110c-e839-e063-6294a90a89d7 2024-02-16 Warnings Exact identifier application number: M013 Extra Strength Pain Reliever ACETAMINOPHEN INGLES MARKETS, INC. 115d0b4f-6f0f-79a9-e063-6394a90ab18a 2024-02-14 Warnings Exact identifier application number: M013 PANADOL ACETAMINOPHEN Haleon US Holdings LLC e1799765-c247-42b4-ad6a-8ba7d136abf2 2024-02-06 Warnings Exact identifier application number: M013 Panadol Cold and Flu NonDrowsy ACETAMINOPHEN AND PHENYLEPRINE HCL Haleon US Holdings LLC f626ab17-01c9-4493-ba9e-0c8c11146384 2024-02-06 Warnings Exact identifier application number: M013 PANADOL Extra ACETAMINOPHEN AND CAFFEINE Haleon US Holdings LLC e5c2d88a-d903-4ca0-b895-f27e791dfc4e 2024-02-06 Warnings Exact identifier application number: M013 PANADOL Extra Strength ACETAMINOPHEN Haleon US Holdings LLC b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b 2024-02-06 Warnings Exact identifier application number: M013 PANADOL Extra Strength ACETAMINOPHEN Haleon US Holdings LLC 9d384e88-5c11-4600-ac6c-a38371570138 2024-02-06 Warnings Exact identifier application number: M013
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