Good Sense Mucus DM

Product NDC: 0113-2219
11-digit product format: 001132219
Labeler code: 0113
Product ID: 0113-2219_a85b0808-9644-43aa-9088-3cfde7ea5f61
Type: HUMAN OTC DRUG
Nonproprietary name: dextromethorphan hydrobromide, guaifenesin
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: L. Perrigo Company
Application: ANDA207602
Marketing category: ANDA
Marketing start: 2019-07-10
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
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
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 · 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	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207602-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207602-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2018-03-05	`caaa826d4ba7…`
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…`

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: Good Sense Mucus DM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	30 mg/1
GUAIFENESIN	600 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
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
34f26b33-af34-470a-b57e-921fbdcbd9af	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
0113-2219-01	Good Sense Mucus DM	20 in 1 BOTTLE	TABLET, EXTENDED RELEASE	20	4
0113-2219-01	Good Sense Mucus DM	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	4
0113-2219-49	Good Sense Mucus DM	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	4
0113-2219-49	Good Sense Mucus DM	40 in 1 BOTTLE	TABLET, EXTENDED RELEASE	40	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0113-2219-01	EA - Each	0113-2219	b0256d15-448c-41aa-9847-3b991fcd608c	1	2022-05-04
0113-2219-49	EA - Each	0113-2219	d24588a1-41a9-4bfd-9e76-6e027330485a	1	2024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0113-2219	GOOD SENSE MUCUS DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) TABLET, EXTENDED RELEASE [L. PERRIGO COMPANY]	3	Current NDC, Legacy NDC, 4 package rows	20230726_34f26b33-af34-470a-b57e-921fbdcbd9af.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 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GOOD SENSE MUCUS DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	A-S Medication Solutions	9995f480-da71-4e3b-8154-9eefaeb9299d	2024-09-26	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
Robitussin Maximum Strength 12 Hour Cough and Mucus Relief	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Haleon US Holdings LLC	96409b52-b0ec-444b-bc39-fd41070e9855	2024-04-07	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
equaline mucus dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	United Natural Foods, Inc. dba UNFI	1db69578-2331-4fce-91a4-95c54cb7dc07	2023-08-07	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
Equaline Mucus DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	United Natural Foods, Inc. dba UNFI	04334889-f75e-4a19-a8b4-47b8db18b9aa	2023-08-02	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
DG health mucus dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	Dolgencorp, LLC	add72ca5-94cd-437f-b30f-6149c08b5f21	2022-11-14	Warnings	Exact identifier application applno (ANDA): 207602 application number: ANDA207602
basic care mucus dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	Amazon.com Services LLC	ac01ad52-483a-4cce-9279-51ceecada9b9	2021-07-13	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
1298324	guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral Tablet	PSN	34f26b33-af34-470a-b57e-921fbdcbd9af	4
1298324	12 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral Tablet	SCD	34f26b33-af34-470a-b57e-921fbdcbd9af	4
1298324	dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	34f26b33-af34-470a-b57e-921fbdcbd9af	4
1298324	guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral Tablet	PSN	81fb0ce7-1b13-4b9d-8f98-671ffd9205c3	1
1298324	12 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral Tablet	SCD	81fb0ce7-1b13-4b9d-8f98-671ffd9205c3	1
1298324	dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	81fb0ce7-1b13-4b9d-8f98-671ffd9205c3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0113-2219-01	00113221901	1 BOTTLE in 1 CARTON (0113-2219-01) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2019-07-10	0000-00-00	No	No	Current
0113-2219-49	00113221949	1 BOTTLE in 1 CARTON (0113-2219-49) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2023-06-19		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Perrigo Mucus•DM Drug Facts	L. Perrigo Company	2026-07-13	HUMAN OTC DRUG LABEL	5
Perrigo Mucus DM Drug Facts	Sportpharm LLC	2026-02-23	HUMAN OTC DRUG LABEL	1