MUCUS RELIEF - DM

Product NDC: 73581-406
11-digit product format: 735810406
Labeler code: 73581
Product ID: 73581-406_5506d60e-e6c0-96fe-e063-6394a90aa87a
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin, Dextromethorphan HBr
Dosage form: TABLET
Route: ORAL
Labeler: YYBA CORP
Application: ANDA206941
Marketing category: ANDA
Marketing start: 2026-06-16
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 60; 1200 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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL			2017-03-17
A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL			2017-03-17

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: MUCUS RELIEF - DM
Brand name suffix: MAXIMUM STRENGTH
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	60 mg/1
GUAIFENESIN	1200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
495W7451VQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1099074	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4f6da14e-f2ca-cb33-e063-6394a90a9ff8	Available on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Maximum Strength Mucus Relief DM	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Wal-Mart Stores, Inc.	ff7280e7-804b-423d-add8-54ec2c76fca2	2026-08-28	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
MUCUS RELIEF - DM MAXIMUM STRENGTH	GUAIFENESIN, DEXTROMETHORPHAN HBR	YYBA CORP	4f6da14e-f2ca-cb33-e063-6394a90a9ff8	2026-06-24	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941 ndc (product): 73581-406
GUAIFENESIN AND DEXTROMETHORPHAN HBR	GUAIFENESIN AND DEXTROMETHORPHAN HBR	TOPCO ASSOCIATES LLC	3a9737c0-e413-dfd1-e063-6294a90aaebd	2026-04-23	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	VESPYR BRANDS LLC	1c8fbf40-17c1-4ee9-a2b9-ca4a08e08293	2026-04-13	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Sportpharm LLC	2f170b35-03a8-4d2e-a4ea-21cccf693d9e	2026-02-18	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Sportpharm LLC	3b5c5617-8499-7fc8-e063-6394a90aa86c	2026-02-06	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Aurohealth LLC	88bc399a-2b71-45a7-bdfb-226ff1df0536	2026-01-30	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Aurohealth LLC	d0b0ceb8-ef42-4baa-85b3-4d7d2e6f66b7	2025-11-13	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Target Corporation	15434143-ab8e-4cf9-e063-6394a90a2388	2025-10-30	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
AMAZON BASIC CARE MUCUS DM	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Amazon.com Services LLC	10eda178-a9cf-685c-e063-6294a90ae5ec	2025-09-25	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Maximum Strength Mucus DM Extended Release	GUAIFENESIN AND DEXTROMETHORPHAN HBR	CVS Pharmacy, Inc.	5ea560d1-6443-4271-842c-7801fc6a6043	2025-08-11	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Mucus DM Extended Release	GUAIFENESIN AND DEXTROMETHORPHAN HBR	CVS Pharmacy, Inc.	2aa1889f-bb76-4e70-81b5-c25c4ebab113	2025-08-11	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
MUCUS RELIEF DM	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Better Living Brands LLC	dca1d482-062f-4915-b0a7-c00ab47aaff8	2025-07-25	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Mucus Relief DM MAXIMUM STRENGTH	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Better Living Brands LLC	4ee69f46-3dc6-4249-9b04-186fa0a13e84	2025-07-25	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
COUGH AND CONGESTION EXTENDED RELEASE	GUAIFENESIN AND DEXTROMETHORPHAN HBR	CVS Pharmacy, Inc.	14254a0c-a843-6eec-e063-6394a90a72c5	2025-07-16	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	KROGER COMPANY	15e54152-dc82-6442-e063-6294a90a8541	2025-07-16	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	KROGER COMPANY	15b98b7d-2274-450d-e063-6394a90a8d1d	2025-07-16	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
MAXIMUM STRENGTH COUGH AND CONGESTION EXTENDED RELEASE	GUAIFENESIN AND DEXTROMETHORPHAN HBR	CVS Pharmacy, Inc.	13ee8bb1-9525-a5bc-e063-6294a90a9db9	2025-07-16	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
MUCUS RELIEF DM	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Harris Teeter	17eee39b-5a7a-ba20-e063-6294a90ac392	2025-04-29	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Mucus Relief DM	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Harris Teeter	826d9c3c-7535-48bb-906e-d75e2ec670db	2025-04-29	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
73581-406-01	73581040601	2 BOTTLE in 1 CARTON (73581-406-01) / 50 TABLET in 1 BOTTLE (73581-406-05)	2 bottle	2026-06-16	No	No	Current
73581-406-05	73581040605	50 TABLET in 1 BOTTLE (73581-406-05)	50 tablet	2026-06-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AURO- WELMATE MUCUS RELIEF - DM (MAXIMUM STRENGTH (73581-406) NEW	YYBA CORP	2026-06-24	HUMAN OTC DRUG LABEL	3