Night time cold and flu

Product NDC: 49580-0843
11-digit product format: 495800843
Labeler code: 49580
Product ID: 49580-0843_fdd536fa-56d5-4c1f-a709-fd159141920a
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	49580-0843		D	Discontinued by firm		2026-10-16
excluded package	package	49580-0843	49580-0843-2	D	Discontinued by firm		2026-10-16

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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49580-0843-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49580-0843-2	`f5e01cc5f278…`	`a2eaf40c39c3…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49580-0843-2	2023-05-22	C162847	48780-1	f386c649-a90a-0266-e053-dadaa90a7c1a	Drug Facts
49580-0843-2	2023-01-30	C162847	48780-1	f386c649-a90a-0266-e053-dadaa90a7c1a	Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49580-0843	NIGHT TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [P & L DEVELOPMENT, LLC]	3	Legacy NDC	20230523_7e7dcbb7-3783-4507-8bde-dc14fb00365a.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49580-0843-2	49580084302	355 mL in 1 BOTTLE, PLASTIC (49580-0843-2)	355 ml	2017-12-31	0000-00-00	No	No	Current