Home NDC 57237-367 Dimetane
Product NDC 57237-367
11-digit product format 572370367
Labeler code 57237
Product ID 57237-367_958e9dae-4d1c-40fc-b84d-20f2ed6996c0
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-01-27
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 2027-12-31
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 Dimetane
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength 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 TC2D6JAD40 Internal UNII lookup 8GTS82S83M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1020477 Internal RxNorm lookup 1049909 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 57237-367-01 Dimetane 100 in 1 BOTTLE CAPSULE, LIQUID FILLED 100 1 57237-367-99 Dimetane 1000 in 1 BOTTLE CAPSULE, LIQUID FILLED 1000 1
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 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 57237-367-01 57237036701 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (57237-367-01) 2026-01-27 No No Current 57237-367-99 57237036799 1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (57237-367-99) 2026-01-27 No No Current