Guaifenesin and Dextromethorphan Hydrobromide

Product NDC: 51316-600
11-digit product format: 513160600
Labeler code: 51316
Product ID: 51316-600_4fe39452-8d46-ba50-e063-6294a90ac53a
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin and Dextromethorphan Hydrobromide
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: CVS PHARMACY, INC
Application: ANDA214781
Marketing category: ANDA
Marketing start: 2022-04-19
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
A214781-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL			2021-07-01
A214781-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL			2021-07-01

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 2 · 66 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	A214781-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214781-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214781-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214781-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214781-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214781-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214781-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214781-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214781-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214781-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214781-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214781-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214781-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214781-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214781-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214781-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214781-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214781-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214781-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214781-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214781-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214781-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214781-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214781-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214781-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214781-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214781-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214781-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214781-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214781-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214781-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214781-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214781-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214781-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214781-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214781-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214781-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214781-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214781-001	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214781-002	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	2021-07-01	`6a51e52b5d6a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Guaifenesin and Dextromethorphan Hydrobromide
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
dd00dfc0-e523-4dec-8fc0-50363eadec57	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
51316-600-70	Guaifenesin and Dextromethorphan Hydrobromide	5 in 1 CARTON	TABLET, EXTENDED RELEASE	5		5
51316-600-70	Guaifenesin and Dextromethorphan Hydrobromide	14 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	14		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51316-600	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET, EXTENDED RELEASE [CVS PHARMACY, INC]	3	Current NDC, Legacy NDC, 2 package rows	20220422_dd00dfc0-e523-4dec-8fc0-50363eadec57.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	OHM LABORATORIES INC	f2eb5494-2672-444f-afa3-d1ef8ed1eaa1	2026-04-22	Warnings	Exact identifier application applno (ANDA): 214781 application number: ANDA214781
Guaifenesin and Dextromethorphan Hydrobromide	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	CVS PHARMACY, INC	dd00dfc0-e523-4dec-8fc0-50363eadec57	2026-04-20	Warnings	Exact identifier application applno (ANDA): 214781 application number: ANDA214781 ndc (product): 51316-600
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	OHM LABORATORIES INC	07b9854d-1ec6-4c8a-983e-96ed1e2de1c2	2026-04-20	Warnings	Exact identifier application applno (ANDA): 214781 application number: ANDA214781
MUCUS RELIEF - DM MAXIMUM STRENGTH	GUAIFENESIN, DEXTROMETHORPHAN HBR	YYBA CORP	325b5e55-ba58-312c-e063-6394a90aee55	2025-08-21	Warnings	Exact identifier application applno (ANDA): 214781 application number: ANDA214781
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	PUBLIX SUPER MARKETS, INC	74fa022a-bad9-4d0f-8dda-5624fae3867b	2025-02-10	Warnings	Exact identifier application applno (ANDA): 214781 application number: ANDA214781
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	PUBLIX SUPER MARKETS, INC	9870b7ee-2bfb-42f5-9762-77d2dd13434a	2022-12-06	Warnings	Exact identifier application applno (ANDA): 214781 application number: ANDA214781
Guaifenesin and Dextromethorphan Hydrobromide HBR	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	RITE-AID	2343f031-d658-498a-b5d1-6dcdb26b3cf0	2022-12-06	Warnings	Exact identifier application applno (ANDA): 214781 application number: ANDA214781
Guaifenesin and Dextromethorphan HBr	GUAIFENESIN AND DEXTROMETHORPHAN HBR	SUN PHARMACEUTICAL INDUSTRIES, INC.	06328741-03e3-49cf-ae44-d4c2116e38a3	2022-12-06	Warnings	Exact identifier application applno (ANDA): 214781 application number: ANDA214781
GUAIFENESIN AND DEXTROMETHORPHAN HBR	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Kroger Company	11b3c01a-93c5-4cd1-8422-d3c3d19d8dff	2022-05-24	Warnings	Exact identifier application applno (ANDA): 214781 application number: ANDA214781
GUAIFENESIN AND DEXTROMETHORPHAN HBR	GUAIFENESIN AND DEXTROMETHORPHAN HBR	Kroger Company	8f7200ff-3e4d-414a-a1f9-fe8daac67cb1	2022-05-24	Warnings	Exact identifier application applno (ANDA): 214781 application number: ANDA214781

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	dd00dfc0-e523-4dec-8fc0-50363eadec57	5
1099074	12 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral Tablet	SCD	dd00dfc0-e523-4dec-8fc0-50363eadec57	5
1099074	dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral Tablet	SY	dd00dfc0-e523-4dec-8fc0-50363eadec57	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51316-600-70	51316060070	5 BLISTER PACK in 1 CARTON (51316-600-70) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	5 blister pack	2022-04-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Guaifenesin and Dextromethorphan HBr	CVS PHARMACY, INC \| Ohm Laboratories Inc.	2026-04-20	HUMAN OTC DRUG LABEL	5