Flu HBP

Product NDC
59779-461
Requested package NDC
59779-461-09
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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