Application 091009

Type: ANDA
Sponsor: ACTAVIS LABS FL

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091009-002	GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL			2015-09-03

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 · 43 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	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`f41ea6bd6efb…`

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 6 of 14 · 279 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Mucus Relief Chest Congestion	GUAIFENESIN	Chain Drug Manufacturing Assn	034d39c0-9aad-4dff-a158-a041b9f0504f	2025-12-04	Warnings	Name fallback generic name: GUAIFENESIN
Mucinex	GUAIFENESIN	ATLANTIC BIOLOGICAS CORP.	40c67cca-f202-4652-9507-2442d26cfd67	2025-12-04	Warnings	Name fallback generic name: GUAIFENESIN
Topco Mucus Relief	GUAIFENESIN	Topco Associates, LLC	03c17c06-6919-4ef4-9d0a-4c039940c671	2025-12-03	Warnings	Name fallback generic name: GUAIFENESIN
GUAIFENESIN	GUAIFENESIN	Granules India Ltd	e3531e9e-2ae7-4188-b95a-90f35613fc05	2025-12-02	Warnings	Name fallback brand name: GUAIFENESIN generic name: GUAIFENESIN
Quality Choice Mucus Relief	GUAIFENESIN	Chain Drug Marketing Association	f1a73da7-0dbb-49bd-857e-7dd6bc11b63c	2025-12-02	Warnings	Name fallback generic name: GUAIFENESIN
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 1200 mg	GUAIFENESIN	YYBA CORP	d9d2539b-bd31-66bd-e053-2a95a90aa583	2025-11-27	Warnings	Name fallback generic name: GUAIFENESIN
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mg	GUAIFENESIN	YYBA CORP	d9d1ce2d-d96a-4950-e053-2995a90ad988	2025-11-27	Warnings	Name fallback generic name: GUAIFENESIN
Childrens Chest Congestion Relief	GUAIFENESIN	WALGREENS COMPANY	c1382512-e6f3-4bdf-a9e6-4f68dd5ea553	2025-11-26	Warnings	Name fallback generic name: GUAIFENESIN
Walgreen Cherry	GUAIFENESIN	WALGREEN COMPANY	1f1cb4a5-1ebd-483c-bf82-16931da00e05	2025-11-26	Warnings	Name fallback generic name: GUAIFENESIN
Mucus Relief	GUAIFENESIN	Major Pharmaceuticals	4d98920b-caf7-42d9-bd08-859d27b6d76a	2025-11-24	Warnings	Name fallback generic name: GUAIFENESIN
MUCUS RELIEF MAX	GUAIFENESIN	Better Living Brands, LLC	8b981962-5724-47d0-81f5-945dea169943	2025-11-21	Warnings	Name fallback generic name: GUAIFENESIN
Mucus Relief	GUAIFENESIN	AMERIFOODS TRADING COMPANY	3802d63d-7dba-50de-e063-6294a90acf7b	2025-11-20	Warnings	Name fallback generic name: GUAIFENESIN
MUCUS RELIEF	GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	c5ea5a7a-c806-e5e0-e053-2995a90a15e9	2025-11-17	Warnings	Name fallback generic name: GUAIFENESIN
Guaifenesin 400mg	GUAIFENESIN	Marlex Pharmaceuticals Inc	13f4db4e-687e-9d7b-e063-6294a90ab088	2025-11-13	Warnings	Name fallback generic name: GUAIFENESIN
Guaifenesin 200mg	GUAIFENESIN	Marlex Pharmaceuticals Inc	13b8f480-d1ac-d70c-e063-6394a90ab4f4	2025-11-13	Warnings	Name fallback generic name: GUAIFENESIN
Mucus Relief	GUAIFENESIN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	32f58b4a-3e1b-424f-8296-a9bf9a7d7025	2025-11-11	Warnings	Name fallback generic name: GUAIFENESIN
Guaifenesin	GUAIFENESIN	WALGREEN CO.	51a35002-77ba-47e5-93ab-3f28242d16b6	2025-11-07	Warnings	Name fallback brand name: Guaifenesin generic name: GUAIFENESIN
Guaifenesin	GUAIFENESIN	WALGREEN CO.	0c329d9f-8f1e-4b41-a03b-324e5d1b4ae2	2025-11-07	Warnings	Name fallback brand name: Guaifenesin generic name: GUAIFENESIN
Mucus Relief	GUAIFENESIN	Family Dollar (FAMILY WELLNESS)	1e1a9335-58ac-4722-9188-c847e62e7215	2025-11-05	Warnings	Name fallback generic name: GUAIFENESIN
Mucus Relief	GUAIFENESIN	Family Dollar (FAMILY WELLNESS)	ddc18f31-acb2-4305-929a-f4746efd4224	2025-10-24	Warnings	Name fallback generic name: GUAIFENESIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0325	Good Sense Mucus ER	Guaifenesin	L. Perrigo Company	ANDA	Current
0113-0325	Good Sense Mucus ER	Guaifenesin	L. Perrigo Company	ANDA	Current
0363-0325	mucus relief er	Guaifenesin	Walgreen Company	ANDA	Current
11673-325	Up and Up mucus relief	Guaifenesin	Target Corporation	ANDA	Current
11673-325	Up and Up mucus relief	Guaifenesin	Target Corporation	ANDA	Current
11822-0325	mucus relief	Guaifenesin	Rite Aid Corporation	ANDA	Current
11822-0325	mucus relief	Guaifenesin	Rite Aid Corporation	ANDA	Current
21130-086	Signature Care Mucus Relief Max	Guaifenesin	Safeway	ANDA	Current
21130-086	Signature Care Mucus Relief Max	Guaifenesin	Safeway	ANDA	Current
30142-325	mucus er max	Guaifenesin	Kroger Company	ANDA	Current
36800-325	TopCare Mucus ER	Guaifenesin	Topco Associates LLC	ANDA	Current
37012-325	Mucus ER Max	Guaifenesin	Shopko Stores Operating Co., LLC	ANDA	Current
37808-325	mucus er	Guaifenesin	H E B	ANDA	Current
37808-325	mucus er	Guaifenesin	H E B	ANDA	Current
41163-325	Equaline Mucus ER	Guaifenesin	Supervalu Inc	ANDA	Current
41250-325	Mucus ER	Guaifenesin	Meijer Distribution Inc	ANDA	Current
41250-672	maximum strength mucus relief	Guaifenesin	Meijer Distribution Inc	ANDA	Current
45802-325	Guaifenesin Extended Release	Guaifenesin	Perrigo New York Inc	ANDA	Current
45802-325	Guaifenesin Extended Release	Guaifenesin	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-325	Guaifenesin Extended Release	Guaifenesin	Perrigo New York Inc	ANDA	Current
46122-351	Good Neighbor Pharmacy Mucus ER	Guaifenesin	Amerisource Bergen	ANDA	Current
46122-351	Good Neighbor Pharmacy Mucus ER	Guaifenesin	Amerisource Bergen	ANDA	Current
49035-325	Equate Mucus ER Max	Guaifenesin	Wal-Mart Stores Inc	ANDA	Current
49035-325	Equate Mucus ER Max	Guaifenesin	Wal-Mart Stores Inc	ANDA	Current
49738-325	Smart Sense Mucus Relief ER	Guaifenesin	Kmart Corporation	ANDA	Current
55316-325	Healthy Accents Mucus Relief	Guaifenesin	DZA Brands LLC	ANDA	Current
55910-728	DG Health Mucus ER	Guaifenesin	Dolgencorp, LLC	ANDA	Current
59779-948	Mucus Extended Release	Guaifenesin	CVS Pharmacy	ANDA	Current
59779-948	Mucus Extended Release	Guaifenesin	CVS Pharmacy	ANDA	Current
59779-948	Mucus Extended Release	Guaifenesin	CVS Pharmacy	ANDA	Current
62011-0299	Health Mart Mucus ER	Guaifenesin	Mckesson	ANDA	Current
62011-0299	Health Mart Mucus ER	Guaifenesin	Strategic Sourcing Services LLC	ANDA	Current
68196-325	Members Mark mucus relief ER	Guaifenesin	Sam's West Inc	ANDA	Current
69256-325	Harris Teeter Mucus Relief Max	Guaifenesin	Harris Teeter, LLC	ANDA	Current
70000-0167	Leader Mucus ER Max	Guaifenesin	Cardinal Health	ANDA	Current
70000-0167	Leader Mucus ER Max	Guaifenesin	Cardinal Health	ANDA	Current
70677-0035	sunmark mucus er	Guaifenesin	Strategic Sourcing Services LLC	ANDA	Current
70677-0035	sunmark mucus er	Guaifenesin	Strategic Sourcing Services LLC	ANDA	Current