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 4 of 14 · 279 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tusnel EX	GUAIFENESIN	A-S Medication Solutions	7f703c9c-2256-4524-9d31-c51919399d26	2026-03-03	Warnings	Name fallback generic name: GUAIFENESIN
Revasol Tussin	GUAIFENESIN	Rnv LLC	f66dc593-9023-40e8-9cc3-0380b04b4305	2026-02-23	Warnings	Name fallback generic name: GUAIFENESIN
MUCUS AND CHEST CONGESTION	GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	f341aa99-5339-4087-a98a-469231dfc6d0	2026-02-17	Warnings	Name fallback generic name: GUAIFENESIN
Guaifenesin	GUAIFENESIN	Ohm Laboratories, Inc.	7076e42a-17ff-4c42-9963-2dc02c0a5e49	2026-02-12	Warnings	Name fallback brand name: Guaifenesin generic name: GUAIFENESIN
Mucus Relief Extended Release Maximum Strength	GUAIFENESIN	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	54a59e95-f95a-4bcd-ac9d-8d4ace85277f	2026-02-10	Warnings	Name fallback generic name: GUAIFENESIN
up and up mucus relief	GUAIFENESIN	Target Corporation	7c1598f1-1236-48d2-861b-de4715e3f3d2	2026-02-05	Warnings	Name fallback generic name: GUAIFENESIN
mucus er	GUAIFENESIN	HyVee Inc	74136552-55b2-4dee-9c66-3f84e9dc63d6	2026-02-03	Warnings	Name fallback generic name: GUAIFENESIN
GUAIFENESIN	GUAIFENESIN	Proficient Rx LP	28b31f37-6896-40f5-8f3a-60c93c5c1278	2026-02-01	Warnings	Name fallback brand name: GUAIFENESIN generic name: GUAIFENESIN
MUCUS RELIEF	GUAIFENESIN	Prodose, Inc.	7e5de5b0-18f0-4807-8686-da9821f918ce	2026-01-26	Warnings	Name fallback generic name: GUAIFENESIN
365 WHOLE FOODS MARKET GUAIFENESIN	GUAIFENESIN	Whole Foods Market, Inc.	7c890031-8188-48be-bb69-06db0e01a0c0	2026-01-20	Warnings	Name fallback generic name: GUAIFENESIN
MUCUS AND CHEST CONGESTION	GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	f505e0bd-8881-4e51-a2fc-4e649bac3bff	2026-01-14	Warnings	Name fallback generic name: GUAIFENESIN
Mucus Relief	GUAIFENESIN	HYVEE INC	462cb425-1fdf-0623-e063-6294a90abd18	2026-01-13	Warnings	Name fallback generic name: GUAIFENESIN
GUAIFENESIN 400MG CAPLETS	GUAIFENESIN	Gendose Pharmaceuticals, LLC	e7b82ec7-ef23-50c1-e053-2a95a90a662f	2026-01-10	Warnings	Name fallback generic name: GUAIFENESIN
Guaifenesin	GUAIFENESIN	Oncor Pharmaceuticals	fd35036c-b722-48a3-85fd-60471beb6e74	2026-01-05	Warnings	Name fallback brand name: Guaifenesin generic name: GUAIFENESIN
Reliable-1 Tussin	GUAIFENESIN	RELIABLE 1 LABORATORIES LLC	2a33ff82-49df-7aaa-e063-6294a90a1281	2026-01-02	Warnings	Name fallback generic name: GUAIFENESIN
Llorens Care Tussin	GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	474459c1-bfd7-dec7-e063-6394a90ac18d	2025-12-31	Warnings	Name fallback generic name: GUAIFENESIN
Geri-Tussin	GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	65545ca3-4e93-4b59-9e17-4742e086e8e7	2025-12-31	Warnings	Name fallback generic name: GUAIFENESIN
Curewell Tussin	GUAIFENESIN	RMT HEALTH LLC	47455587-5074-e70d-e063-6294a90a78bb	2025-12-31	Warnings	Name fallback generic name: GUAIFENESIN
Chest Congestion Relief	GUAIFENESIN	RUGBY LABORATORIES	51b088bc-b44f-44b9-a08e-133509a35a2c	2025-12-30	Warnings	Name fallback generic name: GUAIFENESIN
Tusnel EX	GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	77c16288-68c4-476c-995f-86f505663270	2025-12-29	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