Guaifenesin

Product NDC: 55319-902
Requested package NDC: 55319-902-64
11-digit product format: 553190902
Labeler code: 55319
Product ID: 55319-902_20b58c6f-969d-4539-a30c-74e5c83a8335
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Family Dollar, Inc.
Application: ANDA210453
Marketing category: ANDA
Marketing start: 2020-09-22
Marketing end: 0000-00-00
Substance: GUAIFENESIN
Active strength: 1200 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55319-902	55319-902-64	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A210453-001	GUAIFENESIN	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL			2019-10-21
A210453-002	GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL			2019-10-21

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 · 78 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	A210453-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210453-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210453-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210453-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210453-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210453-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210453-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210453-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210453-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210453-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210453-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210453-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210453-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210453-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210453-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210453-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210453-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210453-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210453-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210453-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210453-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210453-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210453-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210453-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210453-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210453-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210453-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210453-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210453-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210453-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210453-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210453-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210453-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210453-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210453-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210453-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210453-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210453-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210453-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210453-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`782e0a99824c…`

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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Guaifenesin	GUAIFENESIN	Aurohealth LLC	062e3d83-8495-4c8f-b1e6-5eb37fd53224	2026-07-03	Warnings	Exact identifier application applno (ANDA): 210453 application number: ANDA210453
Guaifenesin	GUAIFENESIN	TOPCO ASSOCIATES LLC	3a6e96d3-ac86-f388-e063-6394a90ade2d	2026-04-23	Warnings	Exact identifier application applno (ANDA): 210453 application number: ANDA210453
Guaifenesin	GUAIFENESIN	VESPYR BRANDS LLC	e2e3c628-d241-42b6-8c1e-ef997ffa6e87	2026-04-13	Warnings	Exact identifier application applno (ANDA): 210453 application number: ANDA210453
365 WHOLE FOODS MARKET GUAIFENESIN	GUAIFENESIN	Whole Foods Market, Inc.	7c890031-8188-48be-bb69-06db0e01a0c0	2026-01-20	Warnings	Exact identifier application applno (ANDA): 210453 application number: ANDA210453
MUCUS RELIEF MAX	GUAIFENESIN	Better Living Brands, LLC	8b981962-5724-47d0-81f5-945dea169943	2025-11-21	Warnings	Exact identifier application applno (ANDA): 210453 application number: ANDA210453
Guaifenesin	GUAIFENESIN	WALGREEN CO.	51a35002-77ba-47e5-93ab-3f28242d16b6	2025-11-07	Warnings	Exact identifier application applno (ANDA): 210453 application number: ANDA210453
Guaifenesin	GUAIFENESIN	WALGREEN CO.	0c329d9f-8f1e-4b41-a03b-324e5d1b4ae2	2025-11-07	Warnings	Exact identifier application applno (ANDA): 210453 application number: ANDA210453
GUAIFENESIN	GUAIFENESIN	Sam's West Inc	3867a132-1a87-5e08-e063-6294a90a6dc8	2025-08-01	Warnings	Exact identifier application applno (ANDA): 210453 application number: ANDA210453
Guaifenesin	GUAIFENESIN	Aurohealth LLC	4ec1477e-6e33-4c40-a476-cf7f4f00192b	2025-05-08	Warnings	Exact identifier application applno (ANDA): 210453 application number: ANDA210453
Guaifenesin	GUAIFENESIN	Aurohealth LLC	30c27274-a051-4884-b41e-12943d92b199	2025-05-08	Warnings	Exact identifier application applno (ANDA): 210453 application number: ANDA210453
Guaifenesin	GUAIFENESIN	Aurohealth LLC	c3533119-b307-4bad-8c79-254fea08402b	2024-10-28	Warnings	Exact identifier application applno (ANDA): 210453 application number: ANDA210453
Guaifenesin	GUAIFENESIN	Aurohealth LLC	e95b5292-cd6c-4737-9386-f9441fd1bc28	2024-10-28	Warnings	Exact identifier application applno (ANDA): 210453 application number: ANDA210453
Guaifenesin	GUAIFENESIN	BluePoint Laboratories	ee8a2a97-16aa-0f3e-e053-2a95a90a523b	2023-12-12	Warnings	Exact identifier application applno (ANDA): 210453 application number: ANDA210453
Guaifenesin	GUAIFENESIN	Better Living Brands LLC	ba6ccfc6-d2f8-56d0-e053-2a95a90af6a8	2023-12-01	Warnings	Exact identifier application applno (ANDA): 210453 application number: ANDA210453
Guaifenesin	GUAIFENESIN	Aurohealth LLC	84117b6e-4eeb-42b0-90b1-331f70d5a175	2023-12-01	Warnings	Exact identifier application applno (ANDA): 210453 application number: ANDA210453
Guaifenesin	GUAIFENESIN	RITE AID CORPORATION	de16ec42-4a31-4b18-e053-2995a90a78a4	2023-12-01	Warnings	Exact identifier application applno (ANDA): 210453 application number: ANDA210453

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55319-902-64	55319090264	1 BLISTER PACK in 1 CARTON (55319-902-64) > 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	1 blister pack	2020-09-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Family Dollar, Inc. \| Aurohealth LLC \| Aurobindo Pharma Limited	2022-10-29	Human OTC Drug Label	3