Allergy and Sinus Headache Relief

Product NDC
67091-199
11-digit product format
670910199
Labeler code
67091
Product ID
67091-199_3814f283-ee8f-4ac5-ac04-e366d3edf551
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
Dosage form
TABLET
Route
ORAL
Labeler
WinCo Foods, LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2005-06-15
Marketing end
2020-09-07
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; 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 productproduct67091-199DDiscontinued by firm2026-10-16
excluded packagepackage67091-19967091-199-24DDiscontinued by firm2026-10-16

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 packagepackage67091-199-24d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67091-199-24f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67091-199-242ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67091-199-24a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67091-199-24cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67091-199-24cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67091-199-24302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67091-199-24ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67091-199-240efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67091-199-24ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67091-199-24367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67091-199-24557ba5c1ecfa…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 INGREDIENT362O9ITL9DALLERGY AND SINUS HEADACHE RELIEF COMPLETE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE) TABLET [WINCO FOODS, LLC]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY AND SINUS HEADACHE RELIEF COMPLETE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE) TABLET [WINCO FOODS, LLC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJALLERGY AND SINUS HEADACHE RELIEF COMPLETE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE) TABLET [WINCO FOODS, LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DALLERGY AND SINUS HEADACHE RELIEF COMPLETE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE) TABLET [WINCO FOODS, LLC]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY AND SINUS HEADACHE RELIEF COMPLETE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE) TABLET [WINCO FOODS, LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVALLERGY AND SINUS HEADACHE RELIEF COMPLETE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE) TABLET [WINCO FOODS, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLERGY AND SINUS HEADACHE RELIEF COMPLETE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE) TABLET [WINCO FOODS, LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLERGY AND SINUS HEADACHE RELIEF COMPLETE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE) TABLET [WINCO FOODS, LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKALLERGY AND SINUS HEADACHE RELIEF COMPLETE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE) TABLET [WINCO FOODS, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALLERGY AND SINUS HEADACHE RELIEF COMPLETE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE) TABLET [WINCO FOODS, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDALLERGY AND SINUS HEADACHE RELIEF COMPLETE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE) TABLET [WINCO FOODS, LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAALLERGY AND SINUS HEADACHE RELIEF COMPLETE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE) TABLET [WINCO FOODS, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY AND SINUS HEADACHE RELIEF COMPLETE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE) TABLET [WINCO FOODS, LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALLERGY AND SINUS HEADACHE RELIEF COMPLETE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE) TABLET [WINCO FOODS, LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ALLERGY AND SINUS HEADACHE RELIEF COMPLETE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE) TABLET [WINCO FOODS, LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EALLERGY AND SINUS HEADACHE RELIEF COMPLETE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE) TABLET [WINCO FOODS, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLERGY AND SINUS HEADACHE RELIEF COMPLETE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE) TABLET [WINCO FOODS, LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APALLERGY AND SINUS HEADACHE RELIEF COMPLETE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE) TABLET [WINCO FOODS, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UALLERGY AND SINUS HEADACHE RELIEF COMPLETE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE) TABLET [WINCO FOODS, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLERGY AND SINUS HEADACHE RELIEF COMPLETE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE) TABLET [WINCO FOODS, LLC]1