MUCUS RELIEF

Product NDC: 68210-0611
Requested package NDC: 68210-0611-6
11-digit product format: 682100611
Labeler code: 68210
Product ID: 68210-0611_ed344b30-f45d-307c-e053-2a95a90a245b
Type: HUMAN OTC DRUG
Nonproprietary name: GUAIFENESIN
Dosage form: TABLET
Route: ORAL
Labeler: SPIRIT PHARMACEUTICALS LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2020-02-11
Marketing end: 0000-00-00
Substance: GUAIFENESIN
Active strength: 400 mg/1
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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	68210-0611	68210-0611-6	I	Inactivated by FDA		2026-10-12

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
68210-0611-6	MUCUS RELIEF	60 in 1 BOTTLE	TABLET	60		6
68210-0611-6	MUCUS RELIEF	1 in 1 CARTON	TABLET	1		6

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68210-0611	MUCUS RELIEF (GUAIFENESIN) TABLET [SPIRIT PHARMACEUTICALS LLC]	6	Legacy NDC, 2 package rows	20241215_0b0ce8a2-7a3a-49cf-8b47-247ddfd93805.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
359601	guaiFENesin 400 MG Oral Tablet	PSN	0b0ce8a2-7a3a-49cf-8b47-247ddfd93805	6
359601	guaifenesin 400 MG Oral Tablet	SCD	0b0ce8a2-7a3a-49cf-8b47-247ddfd93805	6

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68210-0611-6	68210061106	1 BOTTLE in 1 CARTON (68210-0611-6) > 60 TABLET in 1 BOTTLE	1 bottle	2020-02-11	0000-00-00	No	No	Current