severe sinus

Product NDC
41250-460
11-digit product format
412500460
Labeler code
41250
Product ID
41250-460_790cd929-6121-4527-b90a-5f3b672d8ee0
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, guaifenesin, phenylephrine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Meijer Distribution Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-06-27
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; mg/1
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 productproduct41250-460DDiscontinued by firm2026-10-12
excluded packagepackage41250-46041250-460-62DDiscontinued 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 packagepackage41250-460-62d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41250-460-62f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage41250-460-622ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage41250-460-62a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage41250-460-62cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage41250-460-62cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage41250-460-62302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage41250-460-62ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage41250-460-620efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage41250-460-62ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage41250-460-62367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage41250-460-62557ba5c1ecfa…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 SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER DISTRIBUTION INC]2
GUAIFENESINACTIVE INGREDIENT495W7451VQSEVERE SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER DISTRIBUTION INC]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSEVERE SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER DISTRIBUTION INC]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSEVERE SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER DISTRIBUTION INC]2
GUAIFENESINACTIVE MOIETY495W7451VQSEVERE SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER DISTRIBUTION INC]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSEVERE SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER DISTRIBUTION INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USEVERE SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER DISTRIBUTION INC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SEVERE SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER DISTRIBUTION INC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSEVERE SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER DISTRIBUTION INC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSEVERE SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER DISTRIBUTION INC]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSEVERE SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER DISTRIBUTION INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASEVERE SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER DISTRIBUTION INC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSEVERE SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER DISTRIBUTION INC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ESEVERE SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER DISTRIBUTION INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SEVERE SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER DISTRIBUTION INC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSEVERE SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER DISTRIBUTION INC]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4SEVERE SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER DISTRIBUTION INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSEVERE SINUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER DISTRIBUTION INC]2