Mucinex DM

Product NDC: 50090-6549
11-digit product format: 500906549
Labeler code: 50090
Product ID: 50090-6549_86b06691-64db-44e1-95d9-bede805160a4
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin and Dextromethorphan Hydrobromide
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA021620
Marketing category: NDA
Marketing start: 2012-06-26
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: 2026-12-31
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
N021620-001	MUCINEX DM	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2004-04-29
N021620-002	MUCINEX DM	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-29

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`782e0a99824c…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021620-001	6372252	2020-04-28		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021620-001	6955821	2020-04-28	U-685	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021620-001	7838032	2020-04-28		Drug product	2010-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021620-002	6372252	2020-04-28		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021620-002	6955821	2020-04-28	U-685	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021620-002	7838032	2020-04-28		Drug product		`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021620-001	6372252	2020-04-28		Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021620-001	6955821	2020-04-28	U-685	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021620-001	7838032	2020-04-28		Drug product	2010-12-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021620-002	6372252	2020-04-28		Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021620-002	6955821	2020-04-28	U-685	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021620-002	7838032	2020-04-28		Drug product		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021620-001	6372252	2020-04-28		Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021620-001	6955821	2020-04-28	U-685	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021620-001	7838032	2020-04-28		Drug product	2010-12-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021620-002	6372252	2020-04-28		Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021620-002	6955821	2020-04-28	U-685	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021620-002	7838032	2020-04-28		Drug product		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021620-001	6372252	2020-04-28		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021620-001	6955821	2020-04-28	U-685	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021620-001	7838032	2020-04-28		Drug product	2010-12-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021620-002	6372252	2020-04-28		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021620-002	6955821	2020-04-28	U-685	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021620-002	7838032	2020-04-28		Drug product		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021620-001	6372252	2020-04-28		Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021620-001	6955821	2020-04-28	U-685	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021620-001	7838032	2020-04-28		Drug product	2010-12-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021620-002	6372252	2020-04-28		Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021620-002	6955821	2020-04-28	U-685	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021620-002	7838032	2020-04-28		Drug product		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021620-001	6372252	2020-04-28		Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021620-001	6955821	2020-04-28	U-685	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021620-001	7838032	2020-04-28		Drug product	2010-12-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021620-002	6372252	2020-04-28		Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021620-002	6955821	2020-04-28	U-685	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021620-002	7838032	2020-04-28		Drug product		`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Mucinex DM
Brand name suffix: Maximum Strength
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	60 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	1200 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
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
104b29ed-a377-4436-8e24-413c63579f2e	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-6549-0	Mucinex DMMaximum Strength	24 in 1 CARTON	TABLET, EXTENDED RELEASE	24		4
50090-6549-0	Mucinex DMMaximum Strength	14 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	14		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-6549-0	EA - Each	50090-6549	cebd36f7-58f3-4664-a9df-12c0f43db585	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-6549	MUCINEX DM MAXIMUM STRENGTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]	4	Current NDC, 2 package rows	20230728_104b29ed-a377-4436-8e24-413c63579f2e.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 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex DM	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	70987d06-d206-445f-bd0d-5e1345b8465c	2026-06-15	Warnings	Exact identifier application applno (NDA): 021620 application number: NDA021620
Mucinex DM Maximum Strength	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	588eddc1-fa30-41cc-8ed9-c01319ea21c6	2026-05-27	Warnings	Exact identifier application applno (NDA): 021620 application number: NDA021620
Mucinex DM	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	A-S Medication Solutions	c04e67da-51f6-4ce3-9852-419d7b3a3742	2026-05-22	Warnings	Exact identifier application applno (NDA): 021620 application number: NDA021620
Mucinex DM	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Sportpharm LLC	8f4af6dd-6df4-49a7-98cf-655136923734	2026-02-26	Warnings	Exact identifier application applno (NDA): 021620 application number: NDA021620
Mucinex DM	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Select Consumer Group	3c9c8fb0-8a00-4b0f-e063-6394a90af632	2025-12-28	Warnings	Exact identifier application applno (NDA): 021620 application number: NDA021620
MUCINEX DM	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	A-S Medication Solutions	fcaf1df9-b396-44f2-94ce-e46e80aba66c	2025-10-01	Warnings	Exact identifier application applno (NDA): 021620 application number: NDA021620
Mucinex DM, TRAVEL BASIX	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Lil' Drug Store Products, Inc.	c274b05c-8f05-4980-9a93-77affb322e57	2023-10-10	Warnings	Exact identifier application applno (NDA): 021620 application number: NDA021620
Mucinex DM Maximum Strength	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	A-S Medication Solutions	104b29ed-a377-4436-8e24-413c63579f2e	2023-07-27	Warnings	Exact identifier application applno (NDA): 021620 application number: NDA021620 ndc (product): 50090-6549
Mucinex DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Navajo Manufacturing Company Inc.	4226f394-f85e-45b1-8d5f-7cffb7dd492f	2023-03-16	Warnings	Exact identifier application applno (NDA): 021620 application number: NDA021620

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
1099074	guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral Tablet	PSN	104b29ed-a377-4436-8e24-413c63579f2e	4
1099074	12 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral Tablet	SCD	104b29ed-a377-4436-8e24-413c63579f2e	4
1099074	dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral Tablet	SY	104b29ed-a377-4436-8e24-413c63579f2e	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-6549-0	50090654900	24 BLISTER PACK in 1 CARTON (50090-6549-0) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	24 blister pack	2023-07-11	No	No	Current