severe congestion and cough/ cold and flu

Product NDC
11822-6485
11-digit product format
118226485
Labeler code
11822
Product ID
11822-6485_8f1f297c-4d56-49ae-b514-7ea233f76b27
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan HBr, guaifenesin, phenylephrine HCl, acetaminophen, diphenhydramine HCl
Dosage form
KIT
Labeler
Rite Aid Corporation
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-07-20
Marketing end
2021-09-07
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 productproduct11822-6485DDiscontinued by firm2026-10-16
excluded packagepackage11822-648511822-6485-1DDiscontinued by firm2026-10-16

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 packagepackage11822-6485-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11822-6485-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11822-6485-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11822-6485-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11822-6485-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11822-6485-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11822-6485-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11822-6485-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11822-6485-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11822-6485-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11822-6485-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11822-6485-1557ba5c1ecfa…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 (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHSEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40SEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
GUAIFENESINACTIVE INGREDIENT495W7451VQSEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSSEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MSEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
GUAIFENESINACTIVE MOIETY495W7451VQSEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ESEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
TALCINACTIVE INGREDIENT7SEV7J4R1USEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1
TRIACETININACTIVE INGREDIENTXHX3C3X673SEVERE CONGESTION AND COUGH/ COLD AND FLU DAYTIME/NIGHTTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL) KIT [RITE AID]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-6485-1118226485011 KIT in 1 PACKAGE (11822-6485-1) * 10 TABLET, FILM COATED in 1 BLISTER PACK * 10 TABLET, FILM COATED in 1 BLISTER PACK1 kit2015-07-202021-09-07NoNoCurrent