Home NDC 37835-537 Acetaminophen and Diphenhydramine Hydrochloride
Product NDC 37835-537
11-digit product format 378350537
Labeler code 37835
Product ID 37835-537_38f722c5-1d77-e710-e063-6394a90ac4d2
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Diphenhydramine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Bi-Mart
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-01
Substance ACETAMINOPHEN; DIPHENHYDRAMINE
Active strength 500 mg/1; 25 mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA]; Histamine-1 Receptor Antagonist [EPC]
Listing certified through 2026-12-31
Current FDA listing Yes NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 3 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded product product 37835-537 E Excluded after deficient or non-compliant submission was not corrected 2026-10-12 excluded package package 37835-537 37835-537-01 E Excluded after deficient or non-compliant submission was not corrected 2026-10-12 excluded package package 37835-537 37835-537-25 E Excluded after deficient or non-compliant submission was not corrected 2026-10-12
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 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 37835-537-01 Acetaminophen and Diphenhydramine Hydrochloride 100 in 1 BOTTLE TABLET 100 2 37835-537-25 Acetaminophen and Diphenhydramine Hydrochloride 250 in 1 BOTTLE TABLET 250 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 37835-537 ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET [BI-MART] 1 2 package rows 20250221_70084eea-1480-4c46-b849-4c779319cb74.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 2 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MAX relief junior ACETAMINOPHEN Akron Pharma Inc. 0e43b885-3843-4f11-9a53-02a38c228313 2026-08-31 Warnings Exact identifier application number: M013 MAX relief junior CHILDREN ACETAMINOPHEN Akron Pharma Inc. d7874e4d-0b38-4bb1-9a62-aa4f66d9baf9 2026-08-31 Warnings Exact identifier application number: M013 MAX relief junior Grape CHILDREN ACETAMINOPHEN Akron Pharma Inc. 3c7a7f40-4963-4fd1-942e-93fa08a45830 2026-08-31 Warnings Exact identifier application number: M013 Genexa Kids Pain and Fever ACETAMINOPHEN Genexa Inc. 5a615118-33c9-1520-e063-6394a90a21a6 2026-08-31 Warnings Exact identifier application number: M013 acetaminophen extra strength ACETAMINOPHEN Sam's West Inc dd99efd0-4ca4-4dc6-a940-bebd17ac8f8d 2026-08-28 Warnings Exact identifier application number: M013 Aspirin 81 mg ASPIRIN HAWAII REPACK, INC. ac94cce3-9a39-41de-bb8b-10a5e5b8e83b 2026-08-28 Warnings Exact identifier application number: M013 Aspirin ASPIRIN WinCo Foods, LLC a0a19cd1-eb8a-4773-be00-78de90d2a3c3 2026-08-28 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN FSA STORE INC. 5502ef15-9f40-db56-e063-6394a90a2de4 2026-08-26 Warnings Exact identifier application number: M013 Dye Free Pain and Fever Childrens ACETAMINOPHEN Walgreens 3ea217dd-e5b9-4d4b-861a-76ce61ba3a1d 2026-08-26 Warnings Exact identifier application number: M013 HyVee Extra Strength Headache Relief CAPLET ACETAMINOPHEN, ASPIRIN, CAFFEINE HyVee Inc 495c75bf-c09a-accd-e063-6294a90a75ec 2026-08-24 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Walgreens 543f93d1-df14-0bd2-e063-6294a90a4413 2026-08-24 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN Akron Pharma Inc. ab79fd60-8315-4c63-8045-1b0511ac268f 2026-08-24 Warnings Exact identifier application number: M013 Genexa Infants Pain and Fever ACETAMINOPHEN Genexa Inc. 4fd048c3-70bc-2ea7-e063-6394a90a55f2 2026-08-22 Warnings Exact identifier application number: M013 Genexa Kids Pain and Fever ACETAMINOPHEN Genexa Inc. 59adabeb-97e8-2de4-e063-6394a90acc47 2026-08-22 Warnings Exact identifier application number: M013 Headache Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE Publix Super Markets Inc a876daa7-ade3-497d-87bb-46d6e4dc185a 2026-08-21 Warnings Exact identifier application number: M013 equate aspirin ASPIRIN Wal-Mart Stores Inc ea3f8eed-7b70-4156-9586-125d27bf29a8 2026-08-19 Warnings Exact identifier application number: M013 aspirin chewable, low dose ASPIRIN United Natural Foods, Inc. dba UNFI 6a6ac7fe-91a4-4b55-979a-b53b51505d8b 2026-08-19 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Sam's West Inc 1098d0e7-8202-4018-a2d2-b0c80ee58b56 2026-08-19 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Safeway, Inc. 5e77dca4-2ff8-4a8c-94bd-f224b680ca23 2026-08-19 Warnings Exact identifier application number: M013 dg health pain relief pm extra strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL Dolgencorp Inc 4d1eddf0-eff7-4c47-b312-30dee08d9e5f 2026-08-19 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 Status 37835-537-01 37835053701 100 TABLET in 1 BOTTLE (37835-537-01) 100 tablet 2025-02-01 0 Current 37835-537-25 37835053725 250 TABLET in 1 BOTTLE (37835-537-25) 250 tablet 2025-02-01 0 Current