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 2 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Aurohealth LLC	cc20129b-2556-4452-9222-afd503f1e7a4	2024-10-03	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Mucus DM	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Amerisource Bergen	bf4bcec8-7136-4ae7-a459-a30ee881b98d	2024-03-29	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Maximum Strength Mucus Relief DM	GUAIFENESIN AND DEXTROMETHORPHAN HBR	WALGREEN CO.	83483b91-77e5-42ca-a467-21312ef32d30	2024-02-03	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Mucus Relief DM	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Wal-Mart Stores, Inc.	48ecf1f4-0571-4d7e-b0cc-309c88b7f1bf	2024-02-03	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Aurohealth LLC	029ee6fb-df76-4df6-b717-70005d5708da	2024-02-03	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Mucus Relief DM	GUAIFENESIN AND DEXTROMETHORPHAN HBR	WALGREEN CO.	40264f92-677e-481e-8d78-5577b2979b01	2024-02-03	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Mucus Relief DM	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Ahold U.S.A., Inc,	738bbea4-4243-4cbd-980e-a22451b85c4c	2023-12-01	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Mucus Relief DM Expectorant and Cough Suppressant Maximum Strength	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Winco Foods, LLC.	ac1c8633-4064-4e2f-9b43-4ae9bdd1a427	2023-12-01	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Mucus Relief DM	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Ahold U.S.A., Inc,	e9add770-58e0-4cf3-bbc2-d293ca870b03	2023-12-01	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Aurohealth LLC	a1921611-343c-4c2a-846d-c8de19dddab5	2023-12-01	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Mucus Relief DM Expectorant and Cough Suppressant	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Winco Foods, LLC.	e7e16bab-a7aa-4911-9a29-0c986b26da67	2023-12-01	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