Cold and Sinus PE Pressure, Pain and Cold

Product NDC
41250-465
11-digit product format
412500465
Labeler code
41250
Product ID
41250-465_0dc9e8fc-5879-459c-8b62-c399d312e9c0
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Meijer Distribution Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2007-02-22
Marketing end
2020-03-29
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; 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 productproduct41250-465DDiscontinued by firm2026-10-15
excluded packagepackage41250-46541250-465-08DDiscontinued 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 packagepackage41250-465-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41250-465-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage41250-465-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage41250-465-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage41250-465-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage41250-465-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage41250-465-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage41250-465-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage41250-465-080efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage41250-465-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage41250-465-08367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage41250-465-08557ba5c1ecfa…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 SINUS PE PRESSURE, PAIN AND COLD NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOLD AND SINUS PE PRESSURE, PAIN AND COLD NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
GUAIFENESINACTIVE INGREDIENT495W7451VQCOLD AND SINUS PE PRESSURE, PAIN AND COLD NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCOLD AND SINUS PE PRESSURE, PAIN AND COLD NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCOLD AND SINUS PE PRESSURE, PAIN AND COLD NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOLD AND SINUS PE PRESSURE, PAIN AND COLD NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
GUAIFENESINACTIVE MOIETY495W7451VQCOLD AND SINUS PE PRESSURE, PAIN AND COLD NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCOLD AND SINUS PE PRESSURE, PAIN AND COLD NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCOLD AND SINUS PE PRESSURE, PAIN AND COLD NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCOLD AND SINUS PE PRESSURE, PAIN AND COLD NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8COLD AND SINUS PE PRESSURE, PAIN AND COLD NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COLD AND SINUS PE PRESSURE, PAIN AND COLD NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DCOLD AND SINUS PE PRESSURE, PAIN AND COLD NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACOLD AND SINUS PE PRESSURE, PAIN AND COLD NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990COLD AND SINUS PE PRESSURE, PAIN AND COLD NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECOLD AND SINUS PE PRESSURE, PAIN AND COLD NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCOLD AND SINUS PE PRESSURE, PAIN AND COLD NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCOLD AND SINUS PE PRESSURE, PAIN AND COLD NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCOLD AND SINUS PE PRESSURE, PAIN AND COLD NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOLD AND SINUS PE PRESSURE, PAIN AND COLD NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [MEIJER]1