Home NDC 69339-151 Diphenhydramine HCl Oral Solution
Product NDC 69339-151
11-digit product format 693390151
Labeler code 69339
Product ID 69339-151_6c998d25-3573-4c6b-822a-1c16eeddd642
Type HUMAN OTC DRUG
Nonproprietary name diphenhydramine hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Natco Pharma USA LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-12-14
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 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 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 69339-151-05 Diphenhydramine HCl Oral Solution 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 6 69339-151-17 Diphenhydramine HCl Oral Solution 4 in 1 CASE SOLUTION 4 6 69339-151-17 Diphenhydramine HCl Oral Solution 10 in 1 TRAY SOLUTION 10 6 69339-151-19 Diphenhydramine HCl Oral Solution 10 in 1 TRAY SOLUTION 10 6 69339-151-19 Diphenhydramine HCl Oral Solution 10 in 1 CASE SOLUTION 10 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69339-151 DIPHENHYDRAMINE HCL ORAL SOLUTION (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [NATCO PHARMA USA LLC] 6 Current NDC, Legacy NDC, 5 package rows 20231102_54b64354-ac10-42ff-a53d-96cef933a91a.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 74 of 180 · 3,583 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 69339-151-05 69339015105 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 69339-151-17 69339015117 4 TRAY in 1 CASE (69339-151-17) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (69339-151-05) 4 tray 2020-12-14 0000-00-00 No No Current 69339-151-19 69339015119 10 TRAY in 1 CASE (69339-151-19) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (69339-151-05) 10 tray 2020-12-14 0000-00-00 No No Current