sinus congestion and pain

Product NDC
30142-460
11-digit product format
301420460
Labeler code
30142
Product ID
30142-460_e932a8ed-4a61-42e4-9eb5-cd386bb64e32
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, guaifenesin, phenylephrine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Kroger Company
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-06-10
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 productproduct30142-460DDiscontinued by firm2026-10-15
excluded packagepackage30142-46030142-460-62DDiscontinued 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 packagepackage30142-460-62d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage30142-460-62f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage30142-460-622ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage30142-460-62a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage30142-460-62cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage30142-460-62cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage30142-460-62302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage30142-460-62ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage30142-460-620efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage30142-460-62ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage30142-460-62367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage30142-460-62557ba5c1ecfa…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 INGREDIENT362O9ITL9DSINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [KROGER COMPANY]2
GUAIFENESINACTIVE INGREDIENT495W7451VQSINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [KROGER COMPANY]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [KROGER COMPANY]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [KROGER COMPANY]2
GUAIFENESINACTIVE MOIETY495W7451VQSINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [KROGER COMPANY]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [KROGER COMPANY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [KROGER COMPANY]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [KROGER COMPANY]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [KROGER COMPANY]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [KROGER COMPANY]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [KROGER COMPANY]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [KROGER COMPANY]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [KROGER COMPANY]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ESINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [KROGER COMPANY]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [KROGER COMPANY]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [KROGER COMPANY]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4SINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [KROGER COMPANY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSINUS CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [KROGER COMPANY]2