Home NDC 69536-345 Dimetapp
Product NDC 69536-345
11-digit product format 695360345
Labeler code 69536
Product ID 69536-345_179134da-6ed7-15b1-e063-6394a90a940f
Type HUMAN OTC DRUG
Nonproprietary name DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form SOLUTION
Route ORAL
Labeler Foundation Consumer Healthcare
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-01
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 12.5 mg/10mL
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 Dimetapp
Brand name suffix Nighttime Cold and Cough
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/10mL
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 1049884 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 69536-345-04 Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Cough 1 in 1 CARTON SOLUTION 12.5 mg in 10mL 1 69536-345-04 DimetappCold and Cough and Nighttime Cold and Cough 1 in 1 CARTON SOLUTION 12.5 mg in 10mL 1 69536-345-04 DimetappNighttime Cold and Cough 1 in 1 CARTON SOLUTION 1 1 69536-345-04 Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Cough 118 mL in 1 BOTTLE SOLUTION 118 mL 12.5 mg in 10mL 1 69536-345-04 DimetappCold and Cough and Nighttime Cold and Cough 118 mL in 1 BOTTLE SOLUTION 118 mL 12.5 mg in 10mL 1 69536-345-04 DimetappNighttime Cold and Cough 118 mL in 1 BOTTLE SOLUTION 118 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69536-345 DIMETAPP COLD AND COUGH AND DIMETAPP NIGHTTIME COLD AND COUGH (BROMPHIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDE) KIT [FOUNDATION CONSUMER HEALTHCARE] 1 Current NDC 20240601_1820e7c7-bc11-9061-e063-6394a90ae581.zip 69536-345 DIMETAPP COLD AND COUGH AND NIGHTTIME COLD AND COUGH (DIPHENHYDRAMINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE) KIT [FOUNDATION CONSUMER HEALTHCARE] 1 Current NDC 20240601_179259a9-231e-df03-e063-6294a90a145e.zip 69536-345 DIMETAPP NIGHTTIME COLD AND COUGH (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [FOUNDATION CONSUMER HEALTHCARE] 1 Current NDC, 2 package rows 20240601_179115ad-d610-99b2-e063-6294a90ae711.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 177 · 3,534 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 69536-345-04 69536034504 1 BOTTLE in 1 CARTON (69536-345-04) / 118 mL in 1 BOTTLE 1 bottle 2024-06-01 No No Current