Mucus Relief DM

Product NDC: 70000-0491
11-digit product format: 700000491
Labeler code: 70000
Product ID: 70000-0491_29abc92c-70fa-4fed-8f4a-267174943ffe
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin, Dextromethorphan HBr
Dosage form: TABLET
Route: ORAL
Labeler: CARDINAL HEALTH 110, LLC. DBA LEADER 70000
Application: ANDA209692
Marketing category: ANDA
Marketing start: 2019-01-31
Marketing end: 2026-08-28
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 30; 600 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
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
A209692-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL			2018-11-01
A209692-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL			2018-11-01

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	A209692-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209692-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209692-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209692-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209692-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209692-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209692-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209692-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209692-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209692-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209692-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209692-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209692-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209692-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209692-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209692-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209692-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209692-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209692-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209692-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209692-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209692-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209692-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209692-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209692-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209692-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209692-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209692-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209692-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209692-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209692-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209692-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209692-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209692-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209692-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209692-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209692-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209692-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209692-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209692-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-11-01	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Mucus Relief DM

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	30 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	600 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
e24fd894-5dee-4f46-aafa-fbf9f0b166fd	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70000-0491-1	Mucus Relief DM	20 in 1 CARTON	TABLET	20		5
70000-0491-1	Mucus Relief DM	1 in 1 BLISTER PACK	TABLET	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0491-1	EA - Each	70000-0491	0bd9dc51-9ee9-4751-a735-b15f77e47aac	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70000-0491	MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [CARDINAL HEALTH (LEADER) 70000]	4	Current NDC, Legacy NDC, 2 package rows	20221021_e24fd894-5dee-4f46-aafa-fbf9f0b166fd.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 1 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucus Relief DM Extended Release Caplets	GUAIFENESIN, DEXTROMETHORPHAN HBR	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	3850544d-0d25-429e-98a9-5c4ad6cfd222	2026-07-14	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	Best Choice (Valu Merchandisers Company)	6d454e89-59ce-40dc-b0d2-3330a7df519f	2026-04-15	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	Best Choice (Valu Merchandisers Company)	344de7bb-de3b-4c15-a920-72d94e5e0e9f	2026-03-18	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	CVS Pharmacy	59c338a0-8dc9-43a7-b8df-c26ae475def3	2026-03-18	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	e24fd894-5dee-4f46-aafa-fbf9f0b166fd	2026-02-10	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692 ndc (product): 70000-0491
Maximum Strength Guaifenesin DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	Rugby Laboratories	2c9515f8-3120-4dbb-a7fc-d89fc5727148	2026-02-10	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM Extended Release Caplets	GUAIFENESIN, DEXTROMETHORPHAN HBR	Rugby Laboratories	69cd399a-0103-4543-bb06-c7cccffe9cc4	2026-02-10	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	P & L Development, LLC	a397799d-46a6-447b-9498-17436d218e29	2026-01-28	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	2426bf76-19bf-4bfd-8f9e-3b348e4b5641	2025-11-11	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	Family Dollar (FAMILY WELLNESS)	ebc1a915-f643-4878-9d7a-67a9c6a26b20	2025-10-30	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	Family Dollar (FAMILY WELLNESS)	b60d1cc6-086c-4483-a101-c5f8d6000969	2025-10-29	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM Extended Release Caplets	GUAIFENESIN, DEXTROMETHORPHAN HBR	Walgreens	be5ab61a-abd6-4dee-9607-2f1e2c47b2dc	2025-08-28	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM Extended Release Caplets Maximum Strength	GUAIFENESIN, DEXTROMETHORPHAN HBR	Walgreens	11310cf8-ea34-47a2-b4d7-fe1131fef462	2025-08-28	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM Maximum Strength	GUAIFENESIN, DEXTROMETHORPHAN HBR	Rite Aid Corporation	8467474f-6278-47d9-8228-451d08ddf983	2025-08-20	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	Rite Aid Corporation	035693ed-d720-430b-98f5-fe4b5dec5db6	2025-08-20	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM Maximum Strength	GUAIFENESIN, DEXTROMETHORPHAN HBR	Chain Drug Consortium, LLC	d6aae1a1-0ab9-4b26-9f62-b8761014bb35	2025-06-30	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM Extended Release Caplets	GUAIFENESIN, DEXTROMETHORPHAN HBR	ATLANTIC BIOLOGICALS CORP.	308f50dd-e8d6-0264-e063-6394a90afa68	2025-06-27	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Amneal Pharmaceuticals LLC	5760a828-1c28-4272-a7b7-ac98466aa294	2024-10-25	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Amneal Pharmaceuticals LLC	cfdbcdb0-531a-4d95-ac5d-64d6d034b252	2024-10-25	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692
Mucus Relief DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	H E B	20df2ffe-5281-4cd6-adb3-3a3d28788ef6	2024-08-02	Warnings	Exact identifier application applno (ANDA): 209692 application number: ANDA209692

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

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	e24fd894-5dee-4f46-aafa-fbf9f0b166fd	5
1298324	12 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral Tablet	SCD	e24fd894-5dee-4f46-aafa-fbf9f0b166fd	5
1298324	dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	e24fd894-5dee-4f46-aafa-fbf9f0b166fd	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70000-0491-1	70000049101	20 BLISTER PACK in 1 CARTON (70000-0491-1) / 1 TABLET in 1 BLISTER PACK	20 blister pack	2019-01-31	2026-08-28	No	No	Current