Cold and Flu Severe

Product NDC: 68016-512
11-digit product format: 680160512
Labeler code: 68016
Product ID: 68016-512_af0cbb19-c0fb-85a0-e053-2995a90afbf7
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form: TABLET, COATED
Route: ORAL
Labeler: CHAIN DRUG CONSORTIUM
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-08-01
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325 mg/1; mg/1; mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
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	68016-512		D	Discontinued by firm		2026-10-16
excluded package	package	68016-512	68016-512-24	D	Discontinued by firm		2026-10-16

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

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68016-512	COLD AND FLU SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG CONSORTIUM]	3	Legacy NDC	20241013_c70e67ee-58e4-4c31-affb-51324c0f7638.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
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68016-512-24	68016051224	2 BLISTER PACK in 1 CARTON (68016-512-24) > 12 TABLET, COATED in 1 BLISTER PACK	2 blister pack	2012-08-01	0000-00-00	No	No	Current