Guaifenesin

Product NDC: 68001-561
11-digit product format: 680010561
Labeler code: 68001
Product ID: 68001-561_0c4ee6ca-2596-fbd2-e063-6394a90a0806
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: BluePoint Laboratories
Application: ANDA210453
Marketing category: ANDA
Marketing start: 2023-03-15
Substance: GUAIFENESIN
Active strength: 600 mg/1
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210453-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210453-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2019-10-21	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Guaifenesin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
495W7451VQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
636522	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ee8a2a97-16aa-0f3e-e053-2a95a90a523b	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68001-561-16	Guaifenesin	10 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	10		4
68001-561-17	Guaifenesin	8 in 1 CARTON	TABLET, EXTENDED RELEASE	8		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-561-16	EA - Each	68001-561	0162114e-b013-487d-8194-63df04f61549	1	2023-03-13
68001-561-17	EA - Each	68001-561	ba15f2d4-8194-47a2-a15d-267437a55bb7	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-561	GUAIFENESIN TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	4	Current NDC, Legacy NDC, 2 package rows	20231213_ee8a2a97-16aa-0f3e-e053-2a95a90a523b.zip

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 ndc (product): 68001-561
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
636522	guaiFENesin 600 MG 12HR Extended Release Oral Tablet	PSN	ee8a2a97-16aa-0f3e-e053-2a95a90a523b	4
636522	12 HR guaifenesin 600 MG Extended Release Oral Tablet	SCD	ee8a2a97-16aa-0f3e-e053-2a95a90a523b	4
636522	guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	ee8a2a97-16aa-0f3e-e053-2a95a90a523b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-561-16	68001056116	10 in 1 BLISTER PACK						Historical
68001-561-17	68001056117	8 BLISTER PACK in 1 CARTON (68001-561-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68001-561-16)	8 blister pack	2023-03-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Guaifenesin Extended Release Tablets 600 mg	BluePoint Laboratories \| APL HEALTHCARE LIMITED	2023-12-12	HUMAN OTC DRUG LABEL	4