Nightime Cold and Flu

Product NDC: 79481-0027
Requested package NDC: 79481-0027-2
11-digit product format: 794810027
Labeler code: 79481
Product ID: 79481-0027_ee27b8fa-a3ee-5ef4-e053-2995a90ab8c9
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Meijer, Inc.
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-09-15
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength: 325 mg/1; mg/1; mg/1
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	79481-0027	79481-0027-2	I	Inactivated by FDA		2026-10-05

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

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79481-0027-2	Nightime Cold and Flu	2 in 1 CARTON	CAPSULE, LIQUID FILLED	2		6
79481-0027-2	Nightime Cold and Flu	12 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	12		6

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79481-0027	NIGHTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MEIJER, INC.]	6	Legacy NDC, 2 package rows	20241222_eac91dcf-ff2a-4131-9fca-c12af71d757e.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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1094549	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule	PSN	eac91dcf-ff2a-4131-9fca-c12af71d757e	6
1094549	acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SCD	eac91dcf-ff2a-4131-9fca-c12af71d757e	6
1094549	APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SY	eac91dcf-ff2a-4131-9fca-c12af71d757e	6

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
79481-0027-2	79481002702	2 BLISTER PACK in 1 CARTON (79481-0027-2) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	2 blister pack	2022-09-15	0000-00-00	No	No	Current