Home NDC 0363-0461-09 Flu HBP
Product NDC 0363-0461
Requested package NDC 0363-0461-09
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
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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D FLU HBP (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [WALGREEN CO.] 4 CHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT V1Q0O9OJ9Z FLU HBP (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [WALGREEN CO.] 4 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH FLU HBP (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [WALGREEN CO.] 4 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D FLU HBP (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [WALGREEN CO.] 4 CHLORPHENIRAMINE ACTIVE MOIETY 3U6IO1965U FLU HBP (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [WALGREEN CO.] 4 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS FLU HBP (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [WALGREEN CO.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FLU HBP (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [WALGREEN CO.] 4 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK FLU HBP (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [WALGREEN CO.] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G FLU HBP (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [WALGREEN CO.] 4 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA FLU HBP (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [WALGREEN CO.] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 FLU HBP (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [WALGREEN CO.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FLU HBP (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [WALGREEN CO.] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A FLU HBP (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [WALGREEN CO.] 4 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 FLU HBP (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [WALGREEN CO.] 4 POVIDONES INACTIVE INGREDIENT FZ989GH94E FLU HBP (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [WALGREEN CO.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FLU HBP (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [WALGREEN CO.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FLU HBP (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [WALGREEN CO.] 4 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP FLU HBP (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [WALGREEN CO.] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U FLU HBP (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [WALGREEN CO.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FLU HBP (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [WALGREEN CO.] 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0363-0461-09 00363046109 2 BLISTER PACK in 1 CARTON (0363-0461-09) > 10 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2005-06-01 2022-03-05 No No Current