Home NDC 69536-355 Dimetapp
Product NDC 69536-355
11-digit product format 695360355
Labeler code 69536
Product ID 69536-355_17925cc1-55d4-5673-e063-6394a90aabcb
Type HUMAN OTC DRUG
Nonproprietary name DIPHENHYDRAMINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, and DEXTROMETHORPHAN HYDROBROMIDE
Dosage form KIT
Labeler Foundation Consumer Healthcare
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-01
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 Cold and Cough and Nighttime Cold and Cough
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049884 Internal RxNorm lookup 2683421 Internal RxNorm lookup 2683422 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 69536-315-04 DimetappCold and Cough and Nighttime Cold and Cough 1 in 1 CARTON SOLUTION 2 mg in 10mL 1 69536-315-04 DimetappCold and Cough and Nighttime Cold and Cough 118 mL in 1 BOTTLE SOLUTION 118 mL 10 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 DimetappCold and Cough and Nighttime Cold and Cough 118 mL in 1 BOTTLE SOLUTION 118 mL 12.5 mg in 10mL 1 69536-355-08 DimetappCold and Cough and Nighttime Cold and Cough 1 in 1 CARTON KIT 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69536-355 DIMETAPP COLD AND COUGH AND NIGHTTIME COLD AND COUGH (DIPHENHYDRAMINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE) KIT [FOUNDATION CONSUMER HEALTHCARE] 1 Current NDC, 5 package rows 20240601_179259a9-231e-df03-e063-6294a90a145e.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 Sample Exclude flag Status 69536-315-04 69536031504 1 in 1 CARTON Historical 69536-345-04 69536034504 1 in 1 CARTON Historical 69536-355-08 69536035508 1 KIT in 1 CARTON (69536-355-08) * 1 BOTTLE in 1 CARTON (69536-345-04) / 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (69536-315-04) / 118 mL in 1 BOTTLE 1 kit 2024-06-01 No No Current