Multi-Symptom Cold and Flu

Product NDC: 41520-068
11-digit product format: 415200068
Labeler code: 41520
Product ID: 41520-068_40f66bcd-3f2e-475c-88d2-345877b98c08
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Care One (American Sales Company)
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2016-07-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	41520-068		D	Discontinued by firm		2026-10-05
excluded package	package	41520-068	41520-068-24	D	Discontinued by firm		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
41520-068-24	Multi-Symptom Cold and FluDayTime	24 in 1 CARTON	CAPSULE, LIQUID FILLED	24		6
41520-068-24	Multi-Symptom Cold and FluDayTime	1 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	1		6

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-068	MULTI-SYMPTOM COLD AND FLU DAYTIME (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]	5	Legacy NDC, 2 package rows	20231006_f9fad6a8-ed8f-45d9-b3d3-422c81f4b83a.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	f9fad6a8-ed8f-45d9-b3d3-422c81f4b83a	6
1086997	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	f9fad6a8-ed8f-45d9-b3d3-422c81f4b83a	6
1086997	APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SY	f9fad6a8-ed8f-45d9-b3d3-422c81f4b83a	6

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41520-068-24	41520006824	24 BLISTER PACK in 1 CARTON (41520-068-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	24 blister pack	2016-07-31	0000-00-00	No	No	Current