MUCUS RELIEF DM

Product NDC: 51316-671
Requested package NDC: 51316-671-66
11-digit product format: 513160671
Labeler code: 51316
Product ID: 51316-671_cb1daa23-e906-4a3f-b3d5-82fe1bef6b35
Type: HUMAN OTC DRUG
Nonproprietary name: dextromethorphan hydrobromide, guaifenesin
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application: ANDA207602
Marketing category: ANDA
Marketing start: 2025-12-17
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 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
A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL			2018-03-05
A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL			2018-03-05

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	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: MUCUS RELIEF DM
Listing expiration: 2027-12-31

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
85ecf5bf-28a1-4b9d-9e99-c9e91ddc85e1	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	SPL version
51316-671-55	MUCUS RELIEF DM	42 in 1 BOTTLE	TABLET, EXTENDED RELEASE	42	3
51316-671-55	MUCUS RELIEF DM	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	3
51316-671-66	MUCUS RELIEF DM	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	3
51316-671-66	MUCUS RELIEF DM	14 in 1 BOTTLE	TABLET, EXTENDED RELEASE	14	3

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 · 37 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RUGBY MUCUS RELIEF DM ER	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Rugby Laboratories	8090d561-0478-435d-ad6f-2334e1823bc3	2026-07-28	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
Good Sense Mucus DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	L. Perrigo Company	34f26b33-af34-470a-b57e-921fbdcbd9af	2026-07-13	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
MUCUS RELIEF DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	db57f6b3-30ca-4a65-9043-f61be24d9b50	2026-06-25	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
mucus relief DM MAX	DEXTROMETHORPHAN HBR, GUAIFENESIN	Rite Aid Corporation	a5fd7378-fd7b-400b-a374-0f3bee37702d	2026-06-03	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
mucus relief DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Rite Aid Corporation	84b5d83d-aea5-42ed-b20c-96d3b389c8c0	2026-05-27	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
mucus dm extended release	GUAIFENESIN, DEXTROMETHORPHAN HBR	CVS Pharmacy	1bc37ee4-df27-4358-b724-6b55406dbce6	2026-05-08	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
mucus dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	HyVee Inc	6bce66d6-e76a-4273-aff9-7ee6adc18980	2026-03-18	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
MUCUS DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	HyVee Inc	4ffa61d9-d24d-4982-a318-1660b56704e6	2026-03-02	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
Good Sense Mucus DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Sportpharm LLC	81fb0ce7-1b13-4b9d-8f98-671ffd9205c3	2026-02-23	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
MUCUS RELIEF DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	85ecf5bf-28a1-4b9d-9e99-c9e91ddc85e1	2026-02-17	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602 ndc (package): 51316-671-66 ndc (product): 51316-671 ndc11 (package): 51316067166
RUGBY MUCUS RELIEF DM ER	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	A-S Medication Solutions	511a5d9b-16a6-481c-a3d3-bcba911ecc9d	2026-02-11	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
Berkley and Jensen Mucus Relief DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	BJWC	d3b94cce-e6f3-43ec-a927-7b7183744433	2025-12-17	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
mucus dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	Meijer Distribution Inc	cb2b9828-1665-4b66-a59a-b9f9539b51b5	2025-09-17	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
GOOD NEIGHBOR PHARMACY MUCUS DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Amerisource Bergen	f0aea945-1c18-4c6f-a7d1-6d56624011bb	2025-09-12	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
good neighbor pharmacy mucus dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	Amerisource Bergen	f7925a6b-7029-4389-bf1b-8c0f5e79b950	2025-09-11	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
kirkland signature mucus dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	Costco Wholesale Company	d2151492-c6bb-42c7-887f-37ef3eab3460	2025-08-20	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
good sense mucus dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	L Perrigo Company	654dc991-1984-43cc-a00e-0c85d910b323	2025-08-20	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
mucus dm extended release	GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE	CVS Pharmacy	6c9540ae-aea1-4717-8dca-60850ebdb1b4	2025-08-04	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
Topcare Mucus DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Topco Associates LLC	c12c68c3-c1bf-45dd-a311-fe1005189ec1	2025-07-16	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
Exchange Select Mucus DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Army & Air Force Exchange Service	99a11bea-8cf5-4c5d-95b1-eaedccaf9e7d	2025-07-03	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602

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	85ecf5bf-28a1-4b9d-9e99-c9e91ddc85e1	3
1099074	12 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral Tablet	SCD	85ecf5bf-28a1-4b9d-9e99-c9e91ddc85e1	3
1099074	dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral Tablet	SY	85ecf5bf-28a1-4b9d-9e99-c9e91ddc85e1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51316-671-66	51316067166	1 BOTTLE in 1 CARTON (51316-671-66) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2026-01-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CVS Pharmacy, Inc. Mucus Relief DM Drug Facts	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	2026-02-17	HUMAN OTC DRUG LABEL	3