Daytime

Product NDC
37012-603
11-digit product format
370120603
Labeler code
37012
Product ID
37012-603_fa20e123-9299-450e-a182-2ae5d0919c96
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
Dosage form
SOLUTION
Route
ORAL
Labeler
Shopko Stores Operating Co., LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-09-02
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/15mL; mg/15mL; mg/15mL; mg/15mL
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 productproduct37012-603DDiscontinued by firm2026-10-15
excluded packagepackage37012-60337012-603-40DDiscontinued 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 packagepackage37012-603-40d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37012-603-40f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37012-603-402ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37012-603-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37012-603-40cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37012-603-40cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37012-603-40302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37012-603-40ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37012-603-400efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37012-603-40ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37012-603-40367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37012-603-40557ba5c1ecfa…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 INGREDIENT362O9ITL9DDAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC]1
GUAIFENESINACTIVE INGREDIENT495W7451VQDAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC]1
GUAIFENESINACTIVE MOIETY495W7451VQDAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UDAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ADAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWDAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RDAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37012-603-4037012060340354 mL in 1 BOTTLE (37012-603-40) 354 ml2015-09-020000-00-00NoNoCurrent