MUCUS RELIEF - DM MAXIMUM STRENGTH

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 mg/1; 1200 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]
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`782e0a99824c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Aurohealth LLC	02d2a5a6-36bb-45b5-aba7-779615b276ed	2025-04-05	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941

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

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	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	0	Current
73581-406-05	73581040605	50 TABLET in 1 BOTTLE (73581-406-05)	50 tablet	2026-06-16	0	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