childrens multi symptom cold

Product NDC
59779-634
11-digit product format
597790634
Labeler code
59779
Product ID
59779-634_72efd514-5cb9-4b24-8ccd-58fcd34b0a80
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan HBr, guaifenesin, phenylephrine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
CVS Pharmacy
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-06-11
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
5 mg/5mL; mg/5mL; mg/5mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59779-634DDiscontinued by firm2026-10-12
excluded packagepackage59779-63459779-634-26DDiscontinued by firm2026-10-12

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
59779-634-26ML - Milliliter59779-634c7822aa7-61a1-4d9f-983a-6bf04d67599212021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-634CHILDRENS MULTI SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]2Legacy NDC20240918_72efd514-5cb9-4b24-8ccd-58fcd34b0a80.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-634-26597790634261 BOTTLE in 1 CARTON (59779-634-26) > 118 mL in 1 BOTTLE1 bottle2016-06-110000-00-00NoNoCurrent