Home NDC 57237-317 Diphenhydramine HCl Oral Solution
Product NDC 57237-317
11-digit product format 572370317
Labeler code 57237
Product ID 57237-317_1478d628-1d0d-491f-b68f-5281dd2ced76
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl Oral
Dosage form SOLUTION
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application M009.50
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-15
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 HCl Oral Solution
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 57237-317-05 Diphenhydramine HCl Oral Solution 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 3 57237-317-51 Diphenhydramine HCl Oral Solution 100 in 1 BOX, UNIT-DOSE SOLUTION 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57237-317 DIPHENHYDRAMINE HCL ORAL SOLUTION (DIPHENHYDRAMINE HCL ORAL) SOLUTION [RISING PHARMA HOLDINGS, INC.] 2 Current NDC, 2 package rows 20241020_7406e4e4-3093-4cd1-80ce-93f7b6db2a87.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 Sample Exclude flag Status 57237-317-05 57237031705 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 57237-317-51 57237031751 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-317-51) / 5 mL in 1 CUP, UNIT-DOSE (57237-317-05) 2023-12-15 No No Current