Cold and Flu Relief

Product NDC
67091-205
11-digit product format
670910205
Labeler code
67091
Product ID
67091-205_646dc4c3-ab45-4260-a059-d5b448b9edf8
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
WinCo Foods, LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-12-31
Marketing end
2020-12-31
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; mg/1
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 productproduct67091-205DDiscontinued by firm2026-10-15
excluded packagepackage67091-20567091-205-24DDiscontinued 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 packagepackage67091-205-24d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67091-205-24f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67091-205-242ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67091-205-24a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67091-205-24cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67091-205-24cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67091-205-24302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67091-205-24ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67091-205-240efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67091-205-24ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67091-205-24367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67091-205-24557ba5c1ecfa…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
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCOLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WINCO FOODS, LLC]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WINCO FOODS, LLC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCOLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WINCO FOODS, LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCOLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WINCO FOODS, LLC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WINCO FOODS, LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCOLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WINCO FOODS, LLC]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UCOLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WINCO FOODS, LLC]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KCOLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WINCO FOODS, LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACOLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WINCO FOODS, LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WINCO FOODS, LLC]1
GELATININACTIVE INGREDIENT2G86QN327LCOLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WINCO FOODS, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WINCO FOODS, LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACOLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WINCO FOODS, LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECOLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WINCO FOODS, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WINCO FOODS, LLC]1
SORBITANINACTIVE INGREDIENT6O92ICV9RUCOLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WINCO FOODS, LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RCOLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WINCO FOODS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RCOLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WINCO FOODS, LLC]1