Cold Formula

Product NDC: 33992-0529
Requested package NDC: 33992-0529-8
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	33992-0529	33992-0529-8	D	Discontinued by firm		2026-10-23

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
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	DAYTIME NIGHTTIME NON-ASPIRIN COLD FORMULA MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [GREENBRIER INTERNATIONAL, INC.]	3
CHLORPHENIRAMINE MALEATE	ACTIVE INGREDIENT	V1Q0O9OJ9Z	DAYTIME NIGHTTIME NON-ASPIRIN COLD FORMULA MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [GREENBRIER INTERNATIONAL, INC.]	3
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	DAYTIME NIGHTTIME NON-ASPIRIN COLD FORMULA MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [GREENBRIER INTERNATIONAL, INC.]	3
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	DAYTIME NIGHTTIME NON-ASPIRIN COLD FORMULA MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [GREENBRIER INTERNATIONAL, INC.]	3
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	DAYTIME NIGHTTIME NON-ASPIRIN COLD FORMULA MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [GREENBRIER INTERNATIONAL, INC.]	3
CHLORPHENIRAMINE	ACTIVE MOIETY	3U6IO1965U	DAYTIME NIGHTTIME NON-ASPIRIN COLD FORMULA MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [GREENBRIER INTERNATIONAL, INC.]	3
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	DAYTIME NIGHTTIME NON-ASPIRIN COLD FORMULA MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [GREENBRIER INTERNATIONAL, INC.]	3
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	DAYTIME NIGHTTIME NON-ASPIRIN COLD FORMULA MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [GREENBRIER INTERNATIONAL, INC.]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DAYTIME NIGHTTIME NON-ASPIRIN COLD FORMULA MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [GREENBRIER INTERNATIONAL, INC.]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	DAYTIME NIGHTTIME NON-ASPIRIN COLD FORMULA MULTI-SYMPTOM (ACETAMINOPHEN, CHLORPEHNIRAMINE HCL, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) KIT [GREENBRIER INTERNATIONAL, INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DAYTIME 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 NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
33992-0529-8	33992052908	1 KIT in 1 CARTON (33992-0529-8) * 12 TABLET, FILM COATED in 1 BLISTER PACK * 12 TABLET, FILM COATED in 1 BLISTER PACK	1 kit	2005-07-21	2022-10-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Assured 44-470C473-08-Delisted	GREENBRIER INTERNATIONAL, INC. \| LNK International, Inc.	2020-03-10	HUMAN OTC DRUG LABEL	8