Home NDC 36800-937 Allergy Relief Caplet
Product NDC 36800-937
11-digit product format 368000937
Labeler code 36800
Product ID 36800-937_452adf86-1162-449c-a974-469bfaa20da9
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler TOPCO ASSOCIATES LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-05-01
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 25 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 Allergy Relief Caplet
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 1049630 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 36800-937-01 Allergy Relief Caplet 1 in 1 CARTON TABLET, FILM COATED 1 5 36800-937-01 Allergy Relief Caplet 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 5 36800-937-40 Allergy Relief Caplet 400 in 1 BOTTLE TABLET, FILM COATED 400 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-937 ALLERGY RELIEF CAPLET (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 5 Current NDC, Legacy NDC, 3 package rows 20250112_126c05e7-2cd9-47d3-96c3-82305714e1db.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 97 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 36800-937-01 36800093701 1 BOTTLE, PLASTIC in 1 CARTON (36800-937-01) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2023-11-09 No No Current 36800-937-40 36800093740 400 TABLET, FILM COATED in 1 BOTTLE (36800-937-40) 2021-05-01 0000-00-00 No No Current