Guaifenesin 1200 mg

Product NDC: 43598-108
11-digit product format: 435980108
Labeler code: 43598
Product ID: 43598-108_ef6a6eb4-cde7-cd56-0290-29d56beec22c
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Dr. Reddy's Laboratories Inc.
Application: ANDA215932
Marketing category: ANDA
Marketing start: 2022-09-01
Substance: GUAIFENESIN
Active strength: 1200 mg/1
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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
A215932-001	GUAIFENESIN	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL			2022-03-15
A215932-002	GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL			2022-03-15

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 · 60 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	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215932-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215932-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2022-03-15	`a72a2bbeb626…`

Additional Listing Data#

Finished product: Yes
Brand name base: Guaifenesin 1200 mg
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	1200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
495W7451VQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310621	Internal RxNorm lookup
636522	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
525fda90-134c-f038-c403-eb5ffc1fb1f1	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
43598-108-37	Guaifenesin 1200 mg	14 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	14		4
43598-108-37	Guaifenesin 1200 mg	3 in 1 CARTON	TABLET, EXTENDED RELEASE	3		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-108	GUAIFENESIN 600 MG (GUAIFENESIN ) TABLET, EXTENDED RELEASE GUAIFENESIN 1200 MG (GUAIFENESIN) TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC.]	3	Current NDC, Legacy NDC, 2 package rows	20241113_525fda90-134c-f038-c403-eb5ffc1fb1f1.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Guaifenesin 1200 mg	GUAIFENESIN	Dr. Reddy's Laboratories Inc.	525fda90-134c-f038-c403-eb5ffc1fb1f1	2025-09-22	Warnings	Exact identifier application applno (ANDA): 215932 application number: ANDA215932 ndc (product): 43598-108
Guaifenesin 600 mg	GUAIFENESIN	CVS Pharmacy	ed242994-facd-750e-b7e1-2eec42c1f65f	2024-11-11	Warnings	Exact identifier application applno (ANDA): 215932 application number: ANDA215932
Guaifenesin 600 mg	GUAIFENESIN	Strategic Sourcing Services, LLC	469c5f00-1b6c-6fc7-a352-65764ff25d45	2024-11-09	Warnings	Exact identifier application applno (ANDA): 215932 application number: ANDA215932
Guaifenesin 600 mg	GUAIFENESIN	Dr. Reddy's Laboratories Inc.	99307c61-5df3-0a83-1e21-ddb03bc905b4	2024-07-26	Warnings	Exact identifier application applno (ANDA): 215932 application number: ANDA215932

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310621	guaiFENesin 1200 MG 12HR Extended Release Oral Tablet	PSN	525fda90-134c-f038-c403-eb5ffc1fb1f1	4
636522	guaiFENesin 600 MG 12HR Extended Release Oral Tablet	PSN	525fda90-134c-f038-c403-eb5ffc1fb1f1	4
310621	12 HR guaifenesin 1200 MG Extended Release Oral Tablet	SCD	525fda90-134c-f038-c403-eb5ffc1fb1f1	4
636522	12 HR guaifenesin 600 MG Extended Release Oral Tablet	SCD	525fda90-134c-f038-c403-eb5ffc1fb1f1	4
310621	guaifenesin 1200 MG 12 HR Extended Release Oral Tablet	SY	525fda90-134c-f038-c403-eb5ffc1fb1f1	4
636522	guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	525fda90-134c-f038-c403-eb5ffc1fb1f1	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43598-108-37	43598010837	3 BLISTER PACK in 1 CARTON (43598-108-37) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	3 blister pack	2022-09-01	0000-00-00	No	No	Current