Application 078912

Type: ANDA
Sponsor: PERRIGO R AND D

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 43.

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
A078912-001	GUAIFENESIN	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL			2011-11-23
A078912-002	GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL			2020-11-05

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 · 81 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	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`bb7c543d1eb4…`

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 2 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DG health mucus er max	GUAIFENESIN	Dolgencorp Inc	4353d561-0e6d-4d36-b356-dd6506b5a3ee	2025-06-06	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
Topcare Mucus ER	GUAIFENESIN	Topco Associates LLC	b787eac7-8f87-49a2-899b-5f524eb7b1fc	2025-05-29	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
Guaifenesin Extended-Release	GUAIFENESIN	Precision Dose Inc.	608b00c5-a2c7-4514-9b46-02954d6675d6	2025-05-27	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
Leader Mucus Relief	GUAIFENESIN	Cardinal Health 110, LLC. dba Leader	34981e01-f405-4feb-807b-3a8c02faca96	2025-03-09	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
Topcare mucus er	GUAIFENESIN	Topco Associates LLC	e3c900ad-21b1-4cd0-8c48-f54f115df403	2024-12-12	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912 ndc (product): 76162-123
DG Health Mucus ER	GUAIFENESIN	Dolgencorp, LLC	bf99fa83-c3be-4052-b5b6-ad91997cb034	2023-04-06	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
mucus	GUAIFENESIN	CVS Pharmacy	d6f1889e-8228-4c8c-a0e9-6c2afdc07e99	2023-01-25	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912 ndc (product): 69842-806
basic care mucus er	GUAIFENESIN	Amazon.com Services LLC	14213a15-5842-456f-a5ab-654268c58f78	2022-04-11	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912 ndc (product): 72288-298

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 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-2023	good sense mucus er	guaifenesin	L. Perrigo Company	ANDA	Current
0113-2023	good sense mucus er	guaifenesin	L. Perrigo Company	ANDA	Current
0615-7712	Guaifenesin Extended Release	Guaifenesin	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
11673-421	up and up mucus relief	guaifenesin	Target Corporation	ANDA	Current
11673-421	up and up mucus relief	guaifenesin	Target Corporation	ANDA	Current
11822-2123	mucus relief	guaifenesin	Rite Aid Corporation	ANDA	Current
41250-684	mucus relief	Guaifenesin	Meijer Distribution Inc	ANDA	Current
41250-684	mucus relief	Guaifenesin	Meijer Distribution Inc	ANDA	Current
41250-684	mucus relief	Guaifenesin	Meijer Distribution Inc	ANDA	Current
49035-498	Equate Mucus ER	Guaifenesin	Wal-Mart Stores Inc	ANDA	Current
55910-310	DG Health Mucus ER	Guaifenesin	Dolgencorp Inc	ANDA	Current
64024-222	welby mucus relief	guaifenesin	Aldi Inc	ANDA	Current
64024-222	welby mucus relief	guaifenesin	Aldi Inc	ANDA	Current
69842-806	mucus	guaifenesin	CVS Pharmacy	ANDA	Current
72288-298	basic care mucus er	Guaifenesin	Amazon.com Services LLC	ANDA	Current
72288-298	basic care mucus er	Guaifenesin	Amazon.com Services LLC	ANDA	Current
72288-298	basic care mucus er	Guaifenesin	Amazon.com Services LLC	ANDA	Current
72288-298	basic care mucus er	Guaifenesin	Amazon.com Services LLC	ANDA	Current
76162-123	Topcare mucus er	guaifenesin	Topco Associates LLC	ANDA	Current
81522-006	caring mill mucus er	guaifenesin	FSA Store Inc.	ANDA	Current