Application 209254

Type: ANDA
Sponsor: OHM LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GUAIFENESIN	GUAIFENESIN	TABLET, EXTENDED RELEASE;ORAL	600MG	No	No
002	GUAIFENESIN	GUAIFENESIN	TABLET, EXTENDED RELEASE;ORAL	1.2GM	No	No

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
A209254-001	GUAIFENESIN	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL			2018-07-16
A209254-002	GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL			2018-07-16

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	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`782e0a99824c…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Guaifenesin	GUAIFENESIN	Ohm Laboratories, Inc.	7076e42a-17ff-4c42-9963-2dc02c0a5e49	2026-02-12	Warnings	Exact identifier application applno (ANDA): 209254 application number: ANDA209254 ndc (product): 51660-566 ndc (product): 51660-567
Guaifenesin Extended Release	GUAIFENESIN	PUBLIX SUPER MARKETS, INC	038e1801-b978-4a2e-ae8c-8803596ec09c	2025-05-20	Warnings	Exact identifier application applno (ANDA): 209254 application number: ANDA209254 ndc (product): 41415-997
GUAIFENESIN	GUAIFENESIN	Publix Super Markets, Inc	435e627c-b4f4-4214-904a-7527aab32cbf	2025-05-20	Warnings	Exact identifier application applno (ANDA): 209254 application number: ANDA209254 ndc (product): 41415-996
Guaifenesin	GUAIFENESIN	AMERISOURCE BERGEN	d1d94d37-4423-4914-9d86-c5ca6d5122f6	2025-04-22	Warnings	Exact identifier application applno (ANDA): 209254 application number: ANDA209254
GUAIFENESIN	GUAIFENESIN	CVS	4efa8bf9-3394-47b4-b630-9476b15d2dfc	2022-11-23	Warnings	Exact identifier application applno (ANDA): 209254 application number: ANDA209254 ndc (product): 51316-071
Guaifenesin Extended Release	GUAIFENESIN	SAM'S WEST INC	64297bb8-cd4e-46d3-ae79-ea4aa4c03bca	2022-06-24	Warnings	Exact identifier application applno (ANDA): 209254 application number: ANDA209254 ndc (product): 68196-996
GUAIFENESIN	GUAIFENESIN	Walmart Stores, Inc.	794e383d-2cae-49d7-9c2d-ae5547bde536	2022-05-09	Warnings	Exact identifier application applno (ANDA): 209254 application number: ANDA209254 ndc (product): 79903-124
GUAIFENESIN	GUAIFENESIN	Kroger Company	d1ffd899-2a2a-41c0-b0c0-7c42f8cabf8d	2022-04-29	Warnings	Exact identifier application applno (ANDA): 209254 application number: ANDA209254 ndc (product): 30142-961
Guaifenesin Extended Release	GUAIFENESIN	Kroger Company	d434656a-221b-40fc-81ad-2b698be1aa33	2022-04-20	Warnings	Exact identifier application applno (ANDA): 209254 application number: ANDA209254 ndc (product): 30142-962

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
30142-961	GUAIFENESIN	Guaifenesin	Kroger Company	ANDA	Current
30142-962	Guaifenesin	Guaifenesin	Kroger Company	ANDA	Current
41415-996	GUAIFENESIN	Guaifenesin	Publix Super Markets, Inc	ANDA	Current
41415-997	Guaifenesin	Guaifenesin	PUBLIX SUPER MARKETS, INC	ANDA	Current
51316-071	GUAIFENESIN	guaifenesin	CVS	ANDA	Current
51660-566	Guaifenesin	Guaifenesin	Ohm Laboratories, Inc.	ANDA	Current
51660-566	Guaifenesin	Guaifenesin	Ohm Laboratories, Inc.	ANDA	Current
51660-567	Guaifenesin	Guaifenesin	Ohm Laboratories, Inc.	ANDA	Current
51660-567	Guaifenesin	Guaifenesin	Ohm Laboratories, Inc.	ANDA	Current
68196-996	Guaifenesin	Guaifenesin	SAM'S WEST INC	ANDA	Current
68196-996	Guaifenesin	Guaifenesin	SAM'S WEST INC	ANDA	Current
68196-996	Guaifenesin	Guaifenesin	SAM'S WEST INC	ANDA	Current
79903-124	GUAIFENESIN	Guaifenesin	Walmart Stores, Inc.	ANDA	Current