Cold Formula

Product NDC
33992-0529
11-digit product format
339920529
Labeler code
33992
Product ID
33992-0529_27139d22-911c-471d-9cdf-cc6229804b2a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl
Dosage form
KIT
Labeler
GREENBRIER INTERNATIONAL, INC.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2005-07-21
Marketing end
2022-10-29
Active strength
0
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 productproduct33992-0529DDiscontinued by firm2026-10-21
excluded packagepackage33992-052933992-0529-8DDiscontinued by firm2026-10-21

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 packagepackage33992-0529-8d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33992-0529-8f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33992-0529-82ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33992-0529-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33992-0529-8cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33992-0529-8cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33992-0529-8302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33992-0529-8ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33992-0529-80efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33992-0529-8ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33992-0529-8367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33992-0529-8557ba5c1ecfa…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 INGREDIENT362O9ITL9DDAYTIME NIGHTTIME NON-ASPIRIN COLD FORMULA MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [GREENBRIER INTERNATIONAL, INC.]3
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZDAYTIME NIGHTTIME NON-ASPIRIN COLD FORMULA MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [GREENBRIER INTERNATIONAL, INC.]3
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDAYTIME NIGHTTIME NON-ASPIRIN COLD FORMULA MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [GREENBRIER INTERNATIONAL, INC.]3
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAYTIME NIGHTTIME NON-ASPIRIN COLD FORMULA MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [GREENBRIER INTERNATIONAL, INC.]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAYTIME NIGHTTIME NON-ASPIRIN COLD FORMULA MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [GREENBRIER INTERNATIONAL, INC.]3
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UDAYTIME NIGHTTIME NON-ASPIRIN COLD FORMULA MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [GREENBRIER INTERNATIONAL, INC.]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDAYTIME NIGHTTIME NON-ASPIRIN COLD FORMULA MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [GREENBRIER INTERNATIONAL, INC.]3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAYTIME NIGHTTIME NON-ASPIRIN COLD FORMULA MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [GREENBRIER INTERNATIONAL, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADAYTIME NIGHTTIME NON-ASPIRIN COLD FORMULA MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [GREENBRIER INTERNATIONAL, INC.]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990DAYTIME NIGHTTIME NON-ASPIRIN COLD FORMULA MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [GREENBRIER INTERNATIONAL, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDAYTIME NIGHTTIME NON-ASPIRIN COLD FORMULA MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [GREENBRIER INTERNATIONAL, INC.]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33992-0529-8339920529081 KIT in 1 CARTON (33992-0529-8) * 12 TABLET, FILM COATED in 1 BLISTER PACK * 12 TABLET, FILM COATED in 1 BLISTER PACK1 kit2005-07-212022-10-29NoNoCurrent