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 1.

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 · 41 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	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…`
2022-09-29 23:25 UTC	2022-09	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091009-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2015-09-03	`cb3db0bc1861…`

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 15 · 281 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucus Relief Extended Release Maximum Strength	GUAIFENESIN	CVS Pharmacy	34314503-b253-4b44-96ff-a42fe2bb161f	2026-07-22	Warnings	Name fallback generic name: GUAIFENESIN
Mucus Relief ER	GUAIFENESIN	Cardinal Health 107, LLC	f7abc2ff-21bc-48b5-9989-c5ac84f5c9cd	2026-07-21	Warnings	Name fallback generic name: GUAIFENESIN
Mucus Relief	GUAIFENESIN	Rugby Laboratories	ee413595-2687-4c38-84ce-18aac933d8e3	2026-07-15	Warnings	Name fallback generic name: GUAIFENESIN
mucus relief	GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	51194399-6ded-4142-8880-9e810e628352	2026-07-13	Warnings	Name fallback generic name: GUAIFENESIN
Good Neighbor Adult Tussin Mucus and chest congestion	GUAIFENESIN	AMERISOURCE BERGEN	97e9cd18-dd55-4a26-80e3-4c17b9e1a1e8	2026-07-13	Warnings	Name fallback generic name: GUAIFENESIN
Guaifenesin 200mg	GUAIFENESIN	Health Pharma USA LLC	d68222f7-b796-7b27-e053-2995a90a2efe	2026-07-07	Warnings	Name fallback generic name: GUAIFENESIN
Mucus Relief Extended Release	GUAIFENESIN	TARGET Corporation	e521e8e1-8227-451a-8858-01c26f6e0657	2026-07-06	Warnings	Name fallback generic name: GUAIFENESIN
Guaifenesin	GUAIFENESIN	Aurohealth LLC	062e3d83-8495-4c8f-b1e6-5eb37fd53224	2026-07-03	Warnings	Name fallback brand name: Guaifenesin generic name: GUAIFENESIN
equate mucus-er	GUAIFENESIN	WALMART INC.	a2cc6dec-388a-46bd-9cbc-1ffb6fd1aea3	2026-07-02	Warnings	Name fallback generic name: GUAIFENESIN
Mucinex	GUAIFENESIN	Bryant Ranch Prepack	a898b584-e17e-45c4-8a28-9f686b95dca0	2026-06-29	Warnings	Name fallback generic name: GUAIFENESIN
Mucinex	GUAIFENESIN	Bryant Ranch Prepack	a8c67e0a-1f2c-4e96-91fe-0d90546d8b1b	2026-06-29	Warnings	Name fallback generic name: GUAIFENESIN
Guaifenesin	GUAIFENESIN	YYBA CORP	4cb11551-31e3-5c01-e063-6394a90ab0d4	2026-06-24	Warnings	Name fallback brand name: Guaifenesin generic name: GUAIFENESIN
MUCUS RELIEF	GUAIFENESIN	YYBA Corp	5074b172-311b-43e2-e063-6394a90aa70f	2026-06-22	Warnings	Name fallback generic name: GUAIFENESIN
Topcare Mucus ER	GUAIFENESIN	Topco Associates LLC	916de841-b1eb-4f00-9e25-1d2e4ab0c6e9	2026-06-18	Warnings	Name fallback generic name: GUAIFENESIN
GUAIFENESIN	GUAIFENESIN	Cardinal Health 107, LLC	888b6a2e-6631-4585-a7fe-eb122eb51b23	2026-06-18	Warnings	Name fallback brand name: GUAIFENESIN generic name: GUAIFENESIN
RUGBY MUCUS RELIEF ER	GUAIFENESIN	Rugby Laboratories	b82ba4cb-8e96-41cc-81c4-ab976410fa30	2026-06-15	Warnings	Name fallback generic name: GUAIFENESIN
Guaifenesin	GUAIFENESIN	Major Pharmaceuticals	aa662428-e61f-4e22-af4d-8cf63df68c99	2026-06-08	Warnings	Name fallback brand name: Guaifenesin generic name: GUAIFENESIN
Mucus Relief	GUAIFENESIN	NCS HealthCare of KY, LLC dba Vangard Labs	41f4f8df-87d4-459f-af6d-3a4356a8115b	2026-06-04	Warnings	Name fallback generic name: GUAIFENESIN
mucus relief	GUAIFENESIN	Rite Aid Corporation	0c68d8f0-7e02-42b3-8150-2ed66a13e282	2026-06-03	Warnings	Name fallback generic name: GUAIFENESIN
Mucinex Maximum Strength	GUAIFENESIN	Reckitt Benckiser LLC	47f5323c-ee3a-400d-b133-31d9c286fafd	2026-05-27	Warnings	Name fallback generic name: GUAIFENESIN

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