Home NDC 51316-745 CVS childrens Cough and Cold
Product NDC 51316-745
11-digit product format 513160745
Labeler code 51316
Product ID 51316-745_cc828679-f233-4204-a020-733c7e59e166
Type HUMAN OTC DRUG
Nonproprietary name chlorpheniramine maleate, dextrometrorphan HBr
Dosage form LIQUID
Route ORAL
Labeler CVS PHARMACY
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-02-17
Substance CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 2; 15 mg/10mL; mg/10mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 CVS childrens Cough and Cold
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORPHENIRAMINE MALEATE 2 mg/10mL DEXTROMETHORPHAN HYDROBROMIDE 15 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V1Q0O9OJ9Z Internal UNII lookup 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1111440 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 51316-745-04 CVS childrens Cough and Cold 118 mL in 1 BOTTLE LIQUID 118 5 51316-745-04 CVS childrens Cough and Cold 1 in 1 CARTON LIQUID 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-745 CVS CHILDRENS COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR) LIQUID [CVS PHARMACY] 4 Current NDC, 2 package rows 20240823_035c5e2a-04e3-490b-8f1a-233a5cb6eadb.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 174 of 174 · 3,464 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE Westminster Pharmaceuticals, LLC a58bfb14-28f9-4425-a5a5-aaff4847c979 2018-03-14 Warnings Exact identifier application number: M012 Chlorpheniramine maleate 4mg CHLORPHENIRAMINE MALEATE 4MG Athlete's Needs, Inc. 4d974959-25fc-4707-9b72-9afbf47b76f1 2017-11-14 Warnings Exact identifier application number: M012 Cold Medicine ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL Selder, S.A. de C.V. d2762d9c-e7e7-42b2-a26a-14b2aa0307cb 2017-01-25 Warnings Exact identifier application number: M012 Allergy CHLORPHENIRAMINE MALEATE Marc Glassman, Inc. 2051247f-ce64-4cf5-b449-9ca14c43ab86 2016-12-27 Warnings Exact identifier application number: M012
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51316-745-04 51316074504 1 BOTTLE in 1 CARTON (51316-745-04) / 118 mL in 1 BOTTLE 1 bottle 2023-02-17 No No Current