Home NDC 81033-029 Diphenhydramine HCl Oral Solution
Product NDC 81033-029
11-digit product format 810330029
Labeler code 81033
Product ID 81033-029_2f871005-de4e-8b2a-e063-6394a90aa43a
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl Oral Solution
Dosage form SOLUTION
Route ORAL
Labeler Kesin Pharma Corporation
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-04
Substance DIPHENHYDRAMINE HCL
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 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 Diphenhydramine HCl Oral Solution
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HCL 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 81033-029-16 Diphenhydramine HCl Oral Solution 473 mL in 1 BOTTLE SOLUTION 473 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81033-029 DIPHENHYDRAMINE HCL ORAL SOLUTION SOLUTION [KESIN PHARMA CORPORATION] 1 Current NDC, 1 package rows 20250330_2f871005-de4d-8b2a-e063-6394a90aa43a.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 73 of 178 · 3,551 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 81033-029-16 81033002916 473 mL in 1 BOTTLE (81033-029-16) 473 ml 2025-03-04 No No Current