Cold and Flu Relief

Product NDC: 49580-0844
Requested package NDC: 49580-0844-2
11-digit product format: 495800844
Labeler code: 49580
Product ID: 49580-0844_2c41aacb-12e5-4e7b-aec2-86e7e1b14b25
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form: LIQUID
Route: ORAL
Labeler: P & L Development, LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2017-12-31
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength: 650 mg/30mL; mg/30mL; mg/30mL
NDC exclude flag: No
Listing certified through: 2020-12-31
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	49580-0844	49580-0844-2	D	Discontinued by firm		2026-10-15

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49580-0844-2	2023-05-24	C162847	48780-1	f386c64a-3d31-0266-e053-dadaa90a7c1a	Drug Facts
49580-0844-2	2023-01-30	C162847	48780-1	f386c64a-3d31-0266-e053-dadaa90a7c1a	Drug Facts

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49580-0844	COLD AND FLU RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [P & L DEVELOPMENT, LLC]	3	Legacy NDC	20230525_63076371-13e9-4116-84f2-e4079855a03c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
V9BI9B5YI2	DOXYLAMINE SUCCINATE	562-10-7	DOXYLAMINE SUCCINATE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49580-0844-2	49580084402	355 mL in 1 BOTTLE, PLASTIC (49580-0844-2)	355 ml	2017-12-31	0000-00-00	No	No	Current