Home NDC 51316-645 CHILDRENS DIMETAPP COLD AND COUGH
Product NDC 51316-645
11-digit product format 513160645
Labeler code 51316
Product ID 51316-645_87047997-d58d-4a04-8068-59e52475b34e
Type HUMAN OTC DRUG
Nonproprietary name brompheniramine maleate, dextromethorphan HBr, phenylephrine HCl
Dosage form LIQUID
Route ORAL
Labeler CVS PHARMACY
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-02-20
Substance BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 2; 10; 5 mg/10mL; mg/10mL; mg/10mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [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 CHILDRENS DIMETAPP COLD AND COUGH
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BROMPHENIRAMINE MALEATE 2 mg/10mL DEXTROMETHORPHAN HYDROBROMIDE 10 mg/10mL PHENYLEPHRINE HYDROCHLORIDE 5 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination IXA7C9ZN03 Internal UNII lookup 9D2RTI9KYH 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 1090463 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 51316-645-08 CHILDRENS DIMETAPP COLD AND COUGH 1 in 1 CARTON LIQUID 1 5 51316-645-08 CHILDRENS DIMETAPP COLD AND COUGH 236 mL in 1 BOTTLE LIQUID 236 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-645 CHILDRENS DIMETAPP COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY] 4 Current NDC, 2 package rows 20240821_7babf4f6-ca0a-44a7-b1ea-d60e20d36f15.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 51316-645-08 51316064508 1 BOTTLE in 1 CARTON (51316-645-08) / 236 mL in 1 BOTTLE 1 bottle 2023-02-20 No No Current