Flu HBP

Product NDC
59779-461
11-digit product format
597790461
Labeler code
59779
Product ID
59779-461_64be3641-070a-4b74-9647-1393d5a710d9
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2005-06-01
Marketing end
2022-02-11
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE
Active strength
500 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 productproduct59779-461DDiscontinued by firm2026-10-12
excluded packagepackage59779-46159779-461-09DDiscontinued 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 packagepackage59779-461-09d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59779-461-09f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59779-461-092ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59779-461-09a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59779-461-09cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59779-461-09cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59779-461-09302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59779-461-09ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59779-461-090efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59779-461-09ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59779-461-09367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59779-461-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-461-09EA - Each59779-461504bd45c-86ce-4287-9ad5-a0b424d9067012022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DFLU HBP (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZFLU HBP (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHFLU HBP (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DFLU HBP (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UFLU HBP (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSFLU HBP (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLU HBP (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFLU HBP (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFLU HBP (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLU HBP (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FLU HBP (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLU HBP (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFLU HBP (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990FLU HBP (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EFLU HBP (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLU HBP (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLU HBP (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFLU HBP (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
TALCINACTIVE INGREDIENT7SEV7J4R1UFLU HBP (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLU HBP (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-461-09597790461092 BLISTER PACK in 1 CARTON (59779-461-09) > 10 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2005-06-012022-02-11NoNoCurrent