Home NDC 80070-350 Dimetapp Cold and Cough and Nighttime Cold and Congestion
Product NDC 80070-350
11-digit product format 800700350
Labeler code 80070
Product ID 80070-350_4b83da33-2837-4fd6-e063-6394a90a3417
Type HUMAN OTC DRUG
Nonproprietary name DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, and DEXTROMETHORPHAN HYDROBROMIDE
Dosage form KIT
Labeler Foundation Consumer Brands
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-09-15
Marketing end 2026-12-31
NDC exclude flag No
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 Cold and Cough and Nighttime Cold and Congestion Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1090463 Internal RxNorm lookup 1236048 Internal RxNorm lookup 1666116 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 80070-310-04 Dimetapp Cold and Cough and Nighttime Cold and Congestion 118 mL in 1 BOTTLE ELIXIR 118 mL 1 mg in 5mL 7 80070-310-04 Dimetapp Cold and Cough and Nighttime Cold and Congestion 1 in 1 CARTON ELIXIR 1 mg in 5mL 7 80070-340-04 Dimetapp Cold and Cough and Nighttime Cold and Congestion 1 in 1 CARTON SOLUTION 6.25 mg in 5mL 7 80070-340-04 Dimetapp Cold and Cough and Nighttime Cold and Congestion 118 mL in 1 BOTTLE SOLUTION 118 mL 2.5 mg in 5mL 7 80070-350-08 Dimetapp Cold and Cough and Nighttime Cold and Congestion 1 in 1 CARTON KIT 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80070-350 DIMETAPP COLD AND COUGH AND NIGHTTIME COLD AND CONGESTION (DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE) KIT [FOUNDATION CONSUMER BRANDS] 6 Current NDC, Legacy NDC, 5 package rows 20240117_1fbe1ce0-5e3e-4af5-a5f1-85ed12ced246.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 Marketing end Sample Exclude flag Status 80070-310-04 80070031004 118 mL in 1 BOTTLE 118 ml Historical 80070-340-04 80070034004 1 in 1 CARTON Historical 80070-350-08 80070035008 1 KIT in 1 CARTON (80070-350-08) * 1 BOTTLE in 1 CARTON (80070-340-04) / 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (80070-310-04) / 118 mL in 1 BOTTLE 1 kit 2021-09-15 2026-12-31 No No Current