Flu HBP

Product NDC
0363-0461
11-digit product format
003630461
Labeler code
0363
Product ID
0363-0461_6e927551-e4c4-49f1-bedf-7ac7b7effba4
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Chlorpheniramine maleate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen Company
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2005-06-01
Marketing end
2022-03-05
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 productproduct0363-0461DDiscontinued by firm2026-10-05
excluded packagepackage0363-04610363-0461-09DDiscontinued 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 packagepackage0363-0461-09d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-0461-09f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0363-0461-092ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0363-0461-09a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0363-0461-09cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0363-0461-09cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-0461-09302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-0461-09ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-0461-090efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0363-0461-09ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0363-0461-09367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0363-0461-09557ba5c1ecfa…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
0363-0461-09EA - Each0363-0461355f86cc-e222-45cb-87da-28718c83b41312012-07-24

DailyMed Socrata Ingredients#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0461-09003630461092 BLISTER PACK in 1 CARTON (0363-0461-09) > 10 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2005-06-010000-00-00NoNoCurrent