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; 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 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 Current NDC, 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 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 37835-537-01 37835053701 100 TABLET in 1 BOTTLE (37835-537-01) 100 tablet 2025-02-01 No No Current 37835-537-25 37835053725 250 TABLET in 1 BOTTLE (37835-537-25) 250 tablet 2025-02-01 No No Current