Childrens Cough and Cold CF

Product NDC
59779-984
Requested package NDC
59779-984-24
11-digit product format
597790984
Labeler code
59779
Product ID
59779-984_d01f04bb-4094-4ab3-829d-70539063edf5
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL
Dosage form
LIQUID
Route
ORAL
Labeler
CVS Pharmacy, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-06-26
Marketing end
2022-04-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 mg/10mL; mg/10mL; mg/10mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage59779-98459779-984-24DDiscontinued by firm2026-10-15

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCHILDRENS COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY, INC.]2
GUAIFENESINACTIVE INGREDIENT495W7451VQCHILDRENS COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY, INC.]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCHILDRENS COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY, INC.]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCHILDRENS COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY, INC.]2
GUAIFENESINACTIVE MOIETY495W7451VQCHILDRENS COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY, INC.]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCHILDRENS COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY, INC.]2
GRAPEINACTIVE INGREDIENT6X543N684KCHILDRENS COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY, INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCHILDRENS COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY, INC.]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS COUGH AND COLD CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [CVS PHARMACY, INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-984-24597790984241 BOTTLE in 1 CARTON (59779-984-24) > 118 mL in 1 BOTTLE1 bottle2015-06-262022-04-01NoNoCurrent