smart sense multi symptom fever and cold

Product NDC
49738-011
11-digit product format
497380011
Labeler code
49738
Product ID
49738-011_8e97abf1-3d9d-4978-9ba0-c6276e83e440
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl
Dosage form
SUSPENSION
Route
ORAL
Labeler
Kmart Corporation
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-10-23
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
160 mg/5mL; 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 productproduct49738-011DDiscontinued by firm2026-10-15
excluded packagepackage49738-01149738-011-26DDiscontinued 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 · 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 packagepackage49738-011-26d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49738-011-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49738-011-262ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49738-011-26a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49738-011-26cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49738-011-26cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49738-011-26302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49738-011-26ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49738-011-260efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49738-011-26ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49738-011-26367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49738-011-26557ba5c1ecfa…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 INGREDIENT362O9ITL9DSMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [KMART CORPORATION]1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZSMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [KMART CORPORATION]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHSMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [KMART CORPORATION]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [KMART CORPORATION]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [KMART CORPORATION]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965USMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [KMART CORPORATION]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSSMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [KMART CORPORATION]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [KMART CORPORATION]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [KMART CORPORATION]1
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505SMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [KMART CORPORATION]1
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJSMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [KMART CORPORATION]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LSMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [KMART CORPORATION]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [KMART CORPORATION]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [KMART CORPORATION]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [KMART CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [KMART CORPORATION]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [KMART CORPORATION]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [KMART CORPORATION]1
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XSMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [KMART CORPORATION]1
SORBITOLINACTIVE INGREDIENT506T60A25RSMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [KMART CORPORATION]1
SUCROSEINACTIVE INGREDIENTC151H8M554SMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [KMART CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RSMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [KMART CORPORATION]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESMART SENSE MULTI SYMPTOM FEVER AND COLD CHILDRENS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SUSPENSION [KMART CORPORATION]1