MUCUS RELIEF DM

Product NDC: 68210-4153
Requested package NDC: 68210-4153-1
11-digit product format: 682104153
Labeler code: 68210
Product ID: 68210-4153_ee8f157c-7ad6-375b-e053-2995a90ac174
Type: HUMAN OTC DRUG
Nonproprietary name: GUAIFENESIN and DEXTROMETHORPHAN HYDROBROMIDE
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Spirit Pharmaceuticals LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2021-04-29
Marketing end: 0000-00-00
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 20 mg/1; mg/1
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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	68210-4153	68210-4153-1	I	Inactivated by FDA		2026-10-20

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

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
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
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68210-4153-1	MUCUS RELIEF DM	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10		5
68210-4153-1	MUCUS RELIEF DM	1 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	1		5

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68210-4153	MUCUS RELIEF DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]	5	Legacy NDC, 2 package rows	20241215_5e1aff7d-41c0-4b39-8b0c-1a5aadda612d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1661740	dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral Capsule	PSN	5e1aff7d-41c0-4b39-8b0c-1a5aadda612d	5
1661740	dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral Capsule	SCD	5e1aff7d-41c0-4b39-8b0c-1a5aadda612d	5

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68210-4153-1	68210415301	1 BLISTER PACK in 1 BLISTER PACK (68210-4153-1) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	1 blister pack	2021-04-29	0000-00-00	No	No	Current