Severe Allergy Plus Sinus Headache

Product NDC
41250-543
11-digit product format
412500543
Labeler code
41250
Product ID
41250-543_befd27cb-618e-440e-a3cf-f3c5522b6b80
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Meijer Distribution Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2007-06-27
Marketing end
2020-06-06
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 productproduct41250-543DDiscontinued by firm2026-10-12
excluded packagepackage41250-54341250-543-09DDiscontinued by firm2026-10-12

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 packagepackage41250-543-09d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41250-543-09f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage41250-543-092ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage41250-543-09a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage41250-543-09cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage41250-543-09cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage41250-543-09302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage41250-543-09ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage41250-543-090efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage41250-543-09ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage41250-543-09367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage41250-543-09557ba5c1ecfa…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 INGREDIENT362O9ITL9DSEVERE ALLERGY PLUS SINUS HEADACHE MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40SEVERE ALLERGY PLUS SINUS HEADACHE MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSEVERE ALLERGY PLUS SINUS HEADACHE MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSEVERE ALLERGY PLUS SINUS HEADACHE MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MSEVERE ALLERGY PLUS SINUS HEADACHE MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSEVERE ALLERGY PLUS SINUS HEADACHE MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USEVERE ALLERGY PLUS SINUS HEADACHE MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SEVERE ALLERGY PLUS SINUS HEADACHE MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSEVERE ALLERGY PLUS SINUS HEADACHE MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSEVERE ALLERGY PLUS SINUS HEADACHE MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSEVERE ALLERGY PLUS SINUS HEADACHE MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SEVERE ALLERGY PLUS SINUS HEADACHE MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESEVERE ALLERGY PLUS SINUS HEADACHE MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASEVERE ALLERGY PLUS SINUS HEADACHE MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ESEVERE ALLERGY PLUS SINUS HEADACHE MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSEVERE ALLERGY PLUS SINUS HEADACHE MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSEVERE ALLERGY PLUS SINUS HEADACHE MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSEVERE ALLERGY PLUS SINUS HEADACHE MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
TRIACETININACTIVE INGREDIENTXHX3C3X673SEVERE ALLERGY PLUS SINUS HEADACHE MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1