DAYTIME COLD AND FLU

Product NDC: 79481-0026
Requested package NDC: 79481-0026-2
11-digit product format: 794810026
Labeler code: 79481
Product ID: 79481-0026_ee27a999-1b92-ad3b-e053-2a95a90a8e33
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: MEIJER, INC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-09-12
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325 mg/1; mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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	79481-0026	79481-0026-2	I	Inactivated by FDA		2026-10-05

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79481-0026-2	DAYTIME COLD AND FLU	2 in 1 CARTON	CAPSULE, LIQUID FILLED	2		9
79481-0026-2	DAYTIME COLD AND FLU	12 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	12		9

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79481-0026	DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MEIJER, INC]	9	Legacy NDC, 2 package rows	20241222_e45ecd53-d125-435a-a5fb-1ffb8b459dbf.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
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1086997	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule	PSN	e45ecd53-d125-435a-a5fb-1ffb8b459dbf	9
1086997	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	e45ecd53-d125-435a-a5fb-1ffb8b459dbf	9
1086997	APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SY	e45ecd53-d125-435a-a5fb-1ffb8b459dbf	9

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
79481-0026-2	79481002602	2 BLISTER PACK in 1 CARTON (79481-0026-2) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	2 blister pack	2022-09-12	0000-00-00	Yes	No	Current