Mucus Relief Sinus Severe Congestion Relief

Product NDC: 68016-549
Requested package NDC: 68016-549-20
11-digit product format: 680160549
Labeler code: 68016
Product ID: 68016-549_af0cbb19-c0ca-85a0-e053-2995a90afbf7
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form: TABLET, COATED
Route: ORAL
Labeler: CHAIN DRUG CONSORTIUM
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-09-01
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68016-549	68016-549-20	D	Discontinued by firm		2026-10-05

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

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68016-549-20	Mucus Relief Sinus Severe Congestion Relief	2 in 1 CARTON	TABLET, COATED	2		3
68016-549-20	Mucus Relief Sinus Severe Congestion Relief	10 in 1 BLISTER PACK	TABLET, COATED	10		3

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68016-549-20	EA - Each	68016-549	ebc8cbf4-0bc2-4993-8a36-0d2fac8a7ca5	1	2022-06-06

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68016-549	MUCUS RELIEF SINUS SEVERE CONGESTION RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG CONSORTIUM]	3	Legacy NDC, 2 package rows	20241013_e0c7ea4d-8a6e-4647-9a8d-dae44ae4a3af.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1243679	acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	e0c7ea4d-8a6e-4647-9a8d-dae44ae4a3af	3
1243679	acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	e0c7ea4d-8a6e-4647-9a8d-dae44ae4a3af	3
1243679	APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	e0c7ea4d-8a6e-4647-9a8d-dae44ae4a3af	3
1243679	APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet	SY	e0c7ea4d-8a6e-4647-9a8d-dae44ae4a3af	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68016-549-20	68016054920	2 BLISTER PACK in 1 CARTON (68016-549-20) > 10 TABLET, COATED in 1 BLISTER PACK	2 blister pack	2014-09-01	0000-00-00	No	No	Current