Mucus DM Extended Release

Product NDC: 69842-057
11-digit product format: 698420057
Labeler code: 69842
Product ID: 69842-057_b793ab0a-5809-46d0-b57a-7ad03b29f959
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin and Dextromethorphan HBr
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: CVS Pharmacy, Inc.
Application: ANDA206941
Marketing category: ANDA
Marketing start: 2017-03-17
Substance: GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 600; 30 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 DM Extended Release
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	600 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1298324	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
2aa1889f-bb76-4e70-81b5-c25c4ebab113	Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69842-057-11	2024-01-30	C162847	48780-1	1030e365-3523-111a-e063-dadaa90a10e2	Drug Facts
69842-057-67	2024-01-30	C162847	48780-1	1030e365-3523-111a-e063-dadaa90a10e2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69842-057-11	Mucus DM Extended Release	4 in 1 CARTON	TABLET, EXTENDED RELEASE	4	9
69842-057-11	Mucus DM Extended Release	10 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	10	9
69842-057-67	Mucus DM Extended Release	10 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	10	9
69842-057-67	Mucus DM Extended Release	2 in 1 CARTON	TABLET, EXTENDED RELEASE	2	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69842-057-11	EA - Each	69842-057	e80319d7-78a1-463d-9cd8-4846d1e363f3	1	2022-07-06
69842-057-67	EA - Each	69842-057	f1ea1f61-6e39-4f6a-b063-e0e354892ab3	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69842-057	MUCUS DM EXTENDED RELEASE (GUAIFENESIN AND DEXTROMETHORPHAN HBR) TABLET, EXTENDED RELEASE [CVS PHARMACY, INC.]	8	Current NDC, Legacy NDC, 4 package rows	20240210_2aa1889f-bb76-4e70-81b5-c25c4ebab113.zip

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
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1298324	guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral Tablet	PSN	2aa1889f-bb76-4e70-81b5-c25c4ebab113	9
1298324	12 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral Tablet	SCD	2aa1889f-bb76-4e70-81b5-c25c4ebab113	9
1298324	dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	2aa1889f-bb76-4e70-81b5-c25c4ebab113	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69842-057-11	69842005711	4 BLISTER PACK in 1 CARTON (69842-057-11) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	4 blister pack	2017-03-17	0000-00-00	No	No	Current
69842-057-67	69842005767	2 BLISTER PACK in 1 CARTON (69842-057-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2 blister pack	2017-03-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	CVS Pharmacy, Inc. \| Aurohealth LLC \| Aurobindo Pharma Limited	2025-08-11	Human OTC Drug Label	9