Severe Congestion and Cough/Cold and Flu

Product NDC
59779-986
11-digit product format
597790986
Labeler code
59779
Product ID
59779-986_6e00054f-deae-437d-8d85-2eea9b6e6204
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl, Acetaminophen, Diphenhydramine HCl
Dosage form
KIT
Labeler
CVS Pharmacy
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-07-20
Marketing end
2021-02-14
Active strength
0
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 productproduct59779-986DDiscontinued by firm2026-10-15
excluded packagepackage59779-98659779-986-01DDiscontinued 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 packagepackage59779-986-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59779-986-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59779-986-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59779-986-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59779-986-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59779-986-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59779-986-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59779-986-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59779-986-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59779-986-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59779-986-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59779-986-01557ba5c1ecfa…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 CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHSEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40SEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
GUAIFENESINACTIVE INGREDIENT495W7451VQSEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSSEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MSEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
GUAIFENESINACTIVE MOIETY495W7451VQSEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ESEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
TALCINACTIVE INGREDIENT7SEV7J4R1USEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1
TRIACETININACTIVE INGREDIENTXHX3C3X673SEVERE CONGESTION AND COUGH/COLD AND FLU DAYTIME/NIGHTTIME/MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]1