daytime nighttime cold and flu relief

Product NDC
37012-003
11-digit product format
370120003
Labeler code
37012
Product ID
37012-003_d74b9b6c-e8f9-4c22-9426-ab7d63da1602
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
Dosage form
KIT
Labeler
Shopko Stores Operating Co., LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-09-02
Marketing end
0000-00-00
Active strength
0
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 productproduct37012-003DDiscontinued by firm2026-10-05
excluded packagepackage37012-00337012-003-02DDiscontinued 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 · 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 packagepackage37012-003-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37012-003-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37012-003-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37012-003-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37012-003-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37012-003-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37012-003-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37012-003-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37012-003-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37012-003-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37012-003-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37012-003-02557ba5c1ecfa…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 NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2DAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
DOXYLAMINEACTIVE MOIETY95QB77JKPLDAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MDAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UDAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SDAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ADAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWDAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554DAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RDAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDAYTIME NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [SHOPKO STORES OPERATING CO., LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37012-003-02370120003021 KIT in 1 CARTON (37012-003-02) * 354 mL in 1 BOTTLE (37012-459-40) * 354 mL in 1 BOTTLE (37012-656-40) 1 kit2015-09-020000-00-00NoNoCurrent