FDA.reportPublic FDA data

Cold and Cough

Product NDC
59779-363
Requested package NDC
59779-363-26
11-digit product format
597790363
Labeler code
59779
Product ID
59779-363_abe87a58-3f3e-432a-93c0-27c697ad453f
Type
HUMAN OTC DRUG
Nonproprietary name
Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
CVS Pharmacy
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2006-08-17
Marketing end
0000-00-00
Substance
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
2 mg/10mL; mg/10mL; mg/10mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59779-36359779-363-26DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59779-36359779-363-26DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-363-26ML - Milliliter59779-3638d5bd68e-e154-4722-9ba6-c2731c08f48812018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BROMPHENIRAMINE MALEATEACTIVE INGREDIENTIXA7C9ZN03COLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]3
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]3
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCOLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]3
BROMPHENIRAMINEACTIVE MOIETYH57G17P2FNCOLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCOLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCOLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCOLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCOLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACOLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3COLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCOLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCOLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]3
SORBITOLINACTIVE INGREDIENT506T60A25RCOLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]3
WATERINACTIVE INGREDIENT059QF0KO0RCOLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-363COLD AND COUGH CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]6Legacy NDC20240925_3cbef359-4184-4ab4-8a84-e6fb6d843792.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-363-26597790363261 BOTTLE in 1 CARTON (59779-363-26) > 118 mL in 1 BOTTLE1 bottle2006-08-170000-00-00NoNoCurrent