Daytime Nighttime Severe Cold and Flu Relief

Product NDC: 49580-0813
11-digit product format: 495800813
Labeler code: 49580
Product ID: 49580-0813_6f770772-77ff-4a8a-89b8-5c75cf4c509a
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen Dextromethorphan HBr Guaifenesin Phenylephrine HCI DoxylamineSucinate
Dosage form: KIT
Labeler: P & L Development, LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2021-03-26
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2022-12-31
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	49580-0813		D	Discontinued by firm		2026-10-05
excluded package	package	49580-0813	49580-0813-6	D	Discontinued by firm		2026-10-05

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	49580-0813-6	`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	49580-0813-6	`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
49580-0813-6	2023-05-17	C162847	48780-1	f386c64a-0ce7-0266-e053-dadaa90a7c1a	Drug Facts
49580-0813-6	2023-01-30	C162847	48780-1	f386c64a-0ce7-0266-e053-dadaa90a7c1a	Drug Facts

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49580-0813-6	49580081306	1 KIT in 1 KIT (49580-0813-6) * 237 mL in 1 BOTTLE * 237 mL in 1 BOTTLE	1 kit	2021-03-26	0000-00-00	No	No	Current