Home NDC 57237-305 Diphenhydramine Oral Liquid
Product NDC 57237-305
11-digit product format 572370305
Labeler code 57237
Product ID 57237-305_952598aa-cb50-400d-85da-e8acab206e5a
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form LIQUID
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application M009.50
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-12-19
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 12.5 mg/5mL
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 Additional Listing Data#
Finished product Yes
Brand name base Diphenhydramine Oral Liquid
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL
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 1049906 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 57237-305-12 Diphenhydramine Oral Liquid 118 mL in 1 BOTTLE LIQUID 118 2 57237-305-16 Diphenhydramine Oral Liquid 473 mL in 1 BOTTLE LIQUID 473 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57237-305 DIPHENHYDRAMINE ORAL LIQUID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RISING PHARMA HOLDINGS, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20241020_d8462e6f-a9fb-4701-97e2-d81a47f3e196.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 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 57237-305-12 57237030512 118 mL in 1 BOTTLE (57237-305-12) 118 ml 2022-12-19 0000-00-00 No No Current 57237-305-16 57237030516 473 mL in 1 BOTTLE (57237-305-16) 473 ml 2022-12-19 0000-00-00 No No Current