Home NDC 80070-300 Dimetapp
Product NDC 80070-300
11-digit product format 800700300
Labeler code 80070
Product ID 80070-300_4b81abf9-3ea9-e996-e063-6394a90a71e8
Type HUMAN OTC DRUG
Nonproprietary name BROMPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE
Dosage form ELIXIR
Route ORAL
Labeler Foundation Consumer Brands
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-09-15
Substance BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 1; 2.5 mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [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 Dimetapp
Brand name suffix Cold and Allergy
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BROMPHENIRAMINE MALEATE 1 mg/5mL PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination IXA7C9ZN03 Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1053258 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 80070-300-04 DimetappCold and Allergy 1 in 1 CARTON ELIXIR 1 5 80070-300-04 DimetappCold and Allergy 118 mL in 1 BOTTLE ELIXIR 118 5 80070-300-08 DimetappCold and Allergy 237 mL in 1 BOTTLE ELIXIR 237 5 80070-300-08 DimetappCold and Allergy 1 in 1 CARTON ELIXIR 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80070-300 DIMETAPP COLD AND ALLERGY (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) ELIXIR [FOUNDATION CONSUMER BRANDS] 4 Current NDC, Legacy NDC, 4 package rows 20241213_47317865-4310-4f07-8815-f3130963307d.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 80070-300-04 80070030004 1 BOTTLE in 1 CARTON (80070-300-04) > 118 mL in 1 BOTTLE 1 bottle 2021-09-15 0000-00-00 No No Current 80070-300-08 80070030008 1 BOTTLE in 1 CARTON (80070-300-08) > 237 mL in 1 BOTTLE 1 bottle 2021-09-15 0000-00-00 No No Current