Application 214407

Type: ANDA
Sponsor: L PERRIGO CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	600MG;60MG	No	No
002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1.2GM;120MG	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
A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL			2022-02-01
A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL			2022-02-01

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 · 64 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	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214407-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214407-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2022-02-01	`1c564ffb4f44…`

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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Mucus Relief D	GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE	Cardinal Health 110, LLC. dba Leader	12971fb2-2314-4443-bf70-b7eb5859b148	2026-05-26	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
mucus d	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Kroger Company	5065f07d-2130-4c84-a64a-dc27ef9cb92e	2026-04-09	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
nasal and chest decongestant	GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE	Publix Super Markets Inc	657aeccc-4f6a-496b-9a69-e64a81e4c91e	2026-04-02	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
equate mucus d	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	WALMART INC.	0d5f6e14-5e42-494b-be1f-a46731007a0d	2026-03-19	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407 ndc (product): 79903-125
mucus d	GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	c8026a56-4249-48de-b763-2d1c55731733	2026-02-26	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
mucus relief d	GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE	Walgreen Company	440c0cf6-d63d-4523-b137-26f70adb977a	2026-02-07	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
foster and thrive mucus relief d	GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE	Strategic Sourcing Services LLC	235a465c-3a5e-4775-92e9-e57fd8d9c9b4	2026-02-07	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
mucus relief d	GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE	H E B	80acd350-7c96-4620-bd7c-848c85f157ed	2026-01-27	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
EQUATE MUCUS D	GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE	WALMART INC.	1ce50a5b-060d-4fb4-ba91-e62fccf9d5f9	2026-01-08	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
Mucus D	GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE	L. Perrigo Company	86993cd9-5d55-4a70-8a33-701d91482292	2025-10-03	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
mucus D	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	L. Perrigo Company	db6ada8a-1799-4d35-8bda-4a322fbd7a06	2025-10-03	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
mucus D	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Meijer, Inc.	5d0c5ded-cf78-4c42-8dc0-8d546884871f	2025-06-10	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
MUCUS D	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	59bce49c-25c9-4710-a68b-271575ceae2f	2025-04-16	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
Rugby Mucus Relief D	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Rugby Laboratories	ec947855-d77b-46ad-88bd-cf05b6ff004b	2025-04-02	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
Leader Mucus Relief D	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Cardinal Health 110, LLC. dba Leader	919f5bf3-3b51-4450-9496-def940b3cb81	2025-03-10	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
Mucus D	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Meijer, Inc.	4a49c617-79d1-488c-a23f-7103c818b365	2025-01-07	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
foster and thrive mucus relief d	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Strategic Sourcing Services LLC	12460719-ff39-49b3-95f8-85e547ad0076	2024-11-21	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
Mucus Relief D	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Walgreen Company	915ca26a-d5d1-40f8-980d-415926e45656	2024-03-30	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
mucus relief d	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	H E B	0a2a2822-ea30-4a50-ad45-d85fd0431f95	2024-01-09	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407
topcare mucus d	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Topco Associates LLC	02134afa-ae8c-4678-a19a-7fd3cab5782f	2023-08-30	Warnings	Exact identifier application applno (ANDA): 214407 application number: ANDA214407

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
79903-125	equate mucus d	guaifenesin and pseudoephedrine hydrochloride	WALMART INC.	ANDA	Current