Childrens Stuffy Nose and Cold

Product NDC
59779-886
11-digit product format
597790886
Labeler code
59779
Product ID
59779-886_d42c105a-1758-4cd0-a14c-2a02fccb8ee2
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin, Phenylephrine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
CVS Pharmacy, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-06-05
Marketing end
2022-03-01
Substance
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
100 mg/5mL; mg/5mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59779-886DDiscontinued by firm2026-10-12
excluded packagepackage59779-88659779-886-24DDiscontinued by firm2026-10-12

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59779-886-24d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59779-886-24f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59779-886-242ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59779-886-24a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59779-886-24cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59779-886-24cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59779-886-24302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59779-886-24ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59779-886-240efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59779-886-24ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59779-886-24367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59779-886-24557ba5c1ecfa…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
GUAIFENESINACTIVE INGREDIENT495W7451VQCHILDRENS STUFFY NOSE AND COLD (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [CVS PHARMACY, INC.]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCHILDRENS STUFFY NOSE AND COLD (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [CVS PHARMACY, INC.]2
GUAIFENESINACTIVE MOIETY495W7451VQCHILDRENS STUFFY NOSE AND COLD (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [CVS PHARMACY, INC.]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCHILDRENS STUFFY NOSE AND COLD (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [CVS PHARMACY, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS STUFFY NOSE AND COLD (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [CVS PHARMACY, INC.]2
BERRYINACTIVE INGREDIENTFV3431923ZCHILDRENS STUFFY NOSE AND COLD (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [CVS PHARMACY, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCHILDRENS STUFFY NOSE AND COLD (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [CVS PHARMACY, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS STUFFY NOSE AND COLD (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [CVS PHARMACY, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS STUFFY NOSE AND COLD (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [CVS PHARMACY, INC.]2
MANGOINACTIVE INGREDIENTI629I3NR86CHILDRENS STUFFY NOSE AND COLD (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [CVS PHARMACY, INC.]2
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92CHILDRENS STUFFY NOSE AND COLD (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [CVS PHARMACY, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS STUFFY NOSE AND COLD (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [CVS PHARMACY, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS STUFFY NOSE AND COLD (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [CVS PHARMACY, INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCHILDRENS STUFFY NOSE AND COLD (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [CVS PHARMACY, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS STUFFY NOSE AND COLD (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [CVS PHARMACY, INC.]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS STUFFY NOSE AND COLD (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [CVS PHARMACY, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS STUFFY NOSE AND COLD (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [CVS PHARMACY, INC.]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECHILDRENS STUFFY NOSE AND COLD (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [CVS PHARMACY, INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-886-24597790886241 BOTTLE in 1 CARTON (59779-886-24) > 118 mL in 1 BOTTLE1 bottle2015-06-052022-03-01NoNoCurrent