Guaifenesin and Dextromethorphan HBr

Product NDC: 58602-714
11-digit product format: 586020714
Labeler code: 58602
Product ID: 58602-714_cfc45418-1bd2-4f68-b1c9-ed3f2bc006aa
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin and Dextromethorphan HBr
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Aurohealth LLC
Application: ANDA206941
Marketing category: ANDA
Marketing start: 2017-03-17
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: 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
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 · 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	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…`
2022-03-09 01:35 UTC	2022-03	A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206941-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206941-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-03-17	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Guaifenesin and Dextromethorphan HBr
Listing expiration: 2026-12-31

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
cc20129b-2556-4452-9222-afd503f1e7a4	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
58602-714-03	Guaifenesin and Dextromethorphan HBr	10 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	10	12
58602-714-05	Guaifenesin and Dextromethorphan HBr	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	12
58602-714-05	Guaifenesin and Dextromethorphan HBr	14 in 1 BOTTLE	TABLET, EXTENDED RELEASE	14	12
58602-714-07	Guaifenesin and Dextromethorphan HBr	6 in 1 CARTON	TABLET, EXTENDED RELEASE	6	12
58602-714-08	Guaifenesin and Dextromethorphan HBr	4 in 1 CARTON	TABLET, EXTENDED RELEASE	4	12
58602-714-09	Guaifenesin and Dextromethorphan HBr	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	12
58602-714-09	Guaifenesin and Dextromethorphan HBr	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	12
58602-714-12	Guaifenesin and Dextromethorphan HBr	40 in 1 BOTTLE	TABLET, EXTENDED RELEASE	40	12
58602-714-12	Guaifenesin and Dextromethorphan HBr	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	12
58602-714-15	Guaifenesin and Dextromethorphan HBr	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60	12
58602-714-15	Guaifenesin and Dextromethorphan HBr	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	12
58602-714-66	Guaifenesin and Dextromethorphan HBr	58 in 1 BOTTLE	TABLET, EXTENDED RELEASE	58	12
58602-714-66	Guaifenesin and Dextromethorphan HBr	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	12
58602-714-67	Guaifenesin and Dextromethorphan HBr	2 in 1 CARTON	TABLET, EXTENDED RELEASE	2	12
58602-714-73	Guaifenesin and Dextromethorphan HBr	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	12
58602-714-73	Guaifenesin and Dextromethorphan HBr	20 in 1 BOTTLE	TABLET, EXTENDED RELEASE	20	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58602-714-67	EA - Each	58602-714	e9aea7b8-ce9e-461f-9e44-2cf997b74be7	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58602-714	GUAIFENESIN AND DEXTROMETHORPHAN HBR TABLET, EXTENDED RELEASE [AUROHEALTH LLC]	12	Current NDC, Legacy NDC, 16 package rows	20241008_cc20129b-2556-4452-9222-afd503f1e7a4.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 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MUCUS RELIEF - DM MAXIMUM STRENGTH	GUAIFENESIN, DEXTROMETHORPHAN HBR	YYBA CORP	4f6da14e-f2ca-cb33-e063-6394a90a9ff8	2026-06-24	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
GUAIFENESIN AND DEXTROMETHORPHAN HBR	GUAIFENESIN AND DEXTROMETHORPHAN HBR	TOPCO ASSOCIATES LLC	3a9737c0-e413-dfd1-e063-6294a90aaebd	2026-04-23	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	VESPYR BRANDS LLC	1c8fbf40-17c1-4ee9-a2b9-ca4a08e08293	2026-04-13	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Sportpharm LLC	2f170b35-03a8-4d2e-a4ea-21cccf693d9e	2026-02-18	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Sportpharm LLC	3b5c5617-8499-7fc8-e063-6394a90aa86c	2026-02-06	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Aurohealth LLC	88bc399a-2b71-45a7-bdfb-226ff1df0536	2026-01-30	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Aurohealth LLC	d0b0ceb8-ef42-4baa-85b3-4d7d2e6f66b7	2025-11-13	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Target Corporation	15434143-ab8e-4cf9-e063-6394a90a2388	2025-10-30	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
AMAZON BASIC CARE MUCUS DM	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Amazon.com Services LLC	10eda178-a9cf-685c-e063-6294a90ae5ec	2025-09-25	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Maximum Strength Mucus DM Extended Release	GUAIFENESIN AND DEXTROMETHORPHAN HBR	CVS Pharmacy, Inc.	5ea560d1-6443-4271-842c-7801fc6a6043	2025-08-11	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Mucus DM Extended Release	GUAIFENESIN AND DEXTROMETHORPHAN HBR	CVS Pharmacy, Inc.	2aa1889f-bb76-4e70-81b5-c25c4ebab113	2025-08-11	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
MUCUS RELIEF DM	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Better Living Brands LLC	dca1d482-062f-4915-b0a7-c00ab47aaff8	2025-07-25	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Mucus Relief DM MAXIMUM STRENGTH	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Better Living Brands LLC	4ee69f46-3dc6-4249-9b04-186fa0a13e84	2025-07-25	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
COUGH AND CONGESTION EXTENDED RELEASE	GUAIFENESIN AND DEXTROMETHORPHAN HBR	CVS Pharmacy, Inc.	14254a0c-a843-6eec-e063-6394a90a72c5	2025-07-16	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	KROGER COMPANY	15e54152-dc82-6442-e063-6294a90a8541	2025-07-16	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	KROGER COMPANY	15b98b7d-2274-450d-e063-6394a90a8d1d	2025-07-16	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
MAXIMUM STRENGTH COUGH AND CONGESTION EXTENDED RELEASE	GUAIFENESIN AND DEXTROMETHORPHAN HBR	CVS Pharmacy, Inc.	13ee8bb1-9525-a5bc-e063-6294a90a9db9	2025-07-16	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
MUCUS RELIEF DM	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Harris Teeter	17eee39b-5a7a-ba20-e063-6294a90ac392	2025-04-29	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
Mucus Relief DM	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Harris Teeter	826d9c3c-7535-48bb-906e-d75e2ec670db	2025-04-29	Warnings	Exact identifier application applno (ANDA): 206941 application number: ANDA206941
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

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	cc20129b-2556-4452-9222-afd503f1e7a4	12
1298324	12 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral Tablet	SCD	cc20129b-2556-4452-9222-afd503f1e7a4	12
1298324	dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	cc20129b-2556-4452-9222-afd503f1e7a4	12
1298324	guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral Tablet	PSN	2f170b35-03a8-4d2e-a4ea-21cccf693d9e	1
1298324	12 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral Tablet	SCD	2f170b35-03a8-4d2e-a4ea-21cccf693d9e	1
1298324	dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	2f170b35-03a8-4d2e-a4ea-21cccf693d9e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58602-714-03	58602071403	10 in 1 BLISTER PACK						Historical
58602-714-05	58602071405	1 BOTTLE in 1 CARTON (58602-714-05) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2017-03-17	0000-00-00	No	No	Current
58602-714-07	58602071407	6 BLISTER PACK in 1 CARTON (58602-714-07) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (58602-714-03)	6 blister pack	2017-03-17	0000-00-00	No	No	Current
58602-714-08	58602071408	4 BLISTER PACK in 1 CARTON (58602-714-08) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (58602-714-03)	4 blister pack	2017-03-17	0000-00-00	No	No	Current
58602-714-09	58602071409	1 BOTTLE in 1 CARTON (58602-714-09) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2017-03-17	0000-00-00	No	No	Current
58602-714-12	58602071412	1 BOTTLE in 1 CARTON (58602-714-12) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2017-03-17	0000-00-00	No	No	Current
58602-714-15	58602071415	1 BOTTLE in 1 CARTON (58602-714-15) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2017-03-17	0000-00-00	No	No	Current
58602-714-66	58602071466	1 BOTTLE in 1 CARTON (58602-714-66) / 58 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2017-03-17	0000-00-00	No	No	Current
58602-714-67	58602071467	2 BLISTER PACK in 1 CARTON (58602-714-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (58602-714-03)	2 blister pack	2017-03-17	0000-00-00	No	No	Current
58602-714-73	58602071473	1 BOTTLE in 1 CARTON (58602-714-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2017-03-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Sportpharm LLC	2026-02-18	HUMAN OTC DRUG LABEL	1
Drug Facts	Aurohealth LLC \| Aurobindo Pharma Limited	2024-10-03	Human OTC Drug Label	12
Drug Facts	Preferred Pharmaceuticals Inc.	2020-07-28	HUMAN OTC DRUG LABEL	2