KMart - Fast Maximum Cold, Flu and Sore Throat Relief

Product NDC
49738-995
Requested package NDC
49738-995-18
11-digit product format
497380995
Labeler code
49738
Product ID
49738-995_70752277-301e-4404-89f3-db3af2856349
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Kmart Corporation
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-08-11
Marketing end
2022-06-22
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650 mg/20mL; mg/20mL; mg/20mL; mg/20mL
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 packagepackage49738-99549738-995-18DDiscontinued 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 · 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
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DKMART - FAST MAXIMUM COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KMART CORPORATION]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHKMART - FAST MAXIMUM COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KMART CORPORATION]1
GUAIFENESINACTIVE INGREDIENT495W7451VQKMART - FAST MAXIMUM COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KMART CORPORATION]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJKMART - FAST MAXIMUM COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KMART CORPORATION]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DKMART - FAST MAXIMUM COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KMART CORPORATION]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSKMART - FAST MAXIMUM COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KMART CORPORATION]1
GUAIFENESINACTIVE MOIETY495W7451VQKMART - FAST MAXIMUM COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KMART CORPORATION]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVKMART - FAST MAXIMUM COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KMART CORPORATION]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLKMART - FAST MAXIMUM COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KMART CORPORATION]1
BERRYINACTIVE INGREDIENTFV3431923ZKMART - FAST MAXIMUM COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KMART CORPORATION]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KKMART - FAST MAXIMUM COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KMART CORPORATION]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDKMART - FAST MAXIMUM COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KMART CORPORATION]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAKMART - FAST MAXIMUM COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KMART CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXKMART - FAST MAXIMUM COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KMART CORPORATION]1
PINEAPPLEINACTIVE INGREDIENT2A88ZO081OKMART - FAST MAXIMUM COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KMART CORPORATION]1
PROPYL GALLATEINACTIVE INGREDIENT8D4SNN7V92KMART - FAST MAXIMUM COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KMART CORPORATION]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3KMART - FAST MAXIMUM COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KMART CORPORATION]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUKMART - FAST MAXIMUM COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KMART CORPORATION]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRKMART - FAST MAXIMUM COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KMART CORPORATION]1
SORBITOLINACTIVE INGREDIENT506T60A25RKMART - FAST MAXIMUM COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KMART CORPORATION]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4KMART - FAST MAXIMUM COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KMART CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RKMART - FAST MAXIMUM COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KMART CORPORATION]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEKMART - FAST MAXIMUM COLD, FLU AND SORE THROAT RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KMART CORPORATION]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49738-995-1849738099518180 mL in 1 BOTTLE (49738-995-18) 180 ml2015-08-112022-06-22NoNoCurrent