Flu HBP

Product NDC
63868-142
11-digit product format
638680142
Labeler code
63868
Product ID
63868-142_e62b975f-fc27-4d29-bc21-d3b55f57a621
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2005-06-01
Marketing end
2022-02-11
Substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
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 productproduct63868-142DDiscontinued by firm2026-10-05
excluded packagepackage63868-14263868-142-20DDiscontinued by firm2026-10-05

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 packagepackage63868-142-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63868-142-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63868-142-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63868-142-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63868-142-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63868-142-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63868-142-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63868-142-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63868-142-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63868-142-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63868-142-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63868-142-20557ba5c1ecfa…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 INGREDIENT362O9ITL9DFLU HBP MAXIUM STRENGTH (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZFLU HBP MAXIUM STRENGTH (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHFLU HBP MAXIUM STRENGTH (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DFLU HBP MAXIUM STRENGTH (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UFLU HBP MAXIUM STRENGTH (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSFLU HBP MAXIUM STRENGTH (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLU HBP MAXIUM STRENGTH (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKFLU HBP MAXIUM STRENGTH (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFLU HBP MAXIUM STRENGTH (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLU HBP MAXIUM STRENGTH (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FLU HBP MAXIUM STRENGTH (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLU HBP MAXIUM STRENGTH (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFLU HBP MAXIUM STRENGTH (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990FLU HBP MAXIUM STRENGTH (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EFLU HBP MAXIUM STRENGTH (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLU HBP MAXIUM STRENGTH (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLU HBP MAXIUM STRENGTH (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFLU HBP MAXIUM STRENGTH (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UFLU HBP MAXIUM STRENGTH (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLU HBP MAXIUM STRENGTH (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-142-20638680142202 BLISTER PACK in 1 CARTON (63868-142-20) > 10 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2005-06-012022-02-11NoNoCurrent