Guaifenesin

Product NDC: 58602-810
11-digit product format: 586020810
Labeler code: 58602
Product ID: 58602-810_e6952325-704d-4774-847c-02a6feb77434
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Aurohealth LLC
Application: ANDA210453
Marketing category: ANDA
Marketing start: 2019-10-21
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 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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (product): 58602-810
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

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
e95b5292-cd6c-4737-9386-f9441fd1bc28	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58602-810-12	Guaifenesin	40 in 1 BOTTLE	TABLET, EXTENDED RELEASE	40	7
58602-810-12	Guaifenesin	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	7
58602-810-21	Guaifenesin	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	7
58602-810-21	Guaifenesin	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	7
58602-810-38	Guaifenesin	10 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	10	7
58602-810-38	Guaifenesin	8 in 1 CARTON	TABLET, EXTENDED RELEASE	8	7
58602-810-73	Guaifenesin	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	7
58602-810-73	Guaifenesin	20 in 1 BOTTLE	TABLET, EXTENDED RELEASE	20	7
58602-810-96	Guaifenesin	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	7
58602-810-96	Guaifenesin	20 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	20	7
58602-810-97	Guaifenesin	2 in 1 CARTON	TABLET, EXTENDED RELEASE	2	7
58602-810-97	Guaifenesin	20 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	20	7
58602-810-98	Guaifenesin	20 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	20	7
58602-810-98	Guaifenesin	5 in 1 CARTON	TABLET, EXTENDED RELEASE	5	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58602-810-97	EA - Each	58602-810	de48e26f-a046-4003-ae9d-f749880526d1	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58602-810	GUAIFENESIN TABLET, EXTENDED RELEASE [AUROHEALTH LLC]	7	Current NDC, Legacy NDC, 14 package rows	20241102_e95b5292-cd6c-4737-9386-f9441fd1bc28.zip

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	e95b5292-cd6c-4737-9386-f9441fd1bc28	7
636522	12 HR guaifenesin 600 MG Extended Release Oral Tablet	SCD	e95b5292-cd6c-4737-9386-f9441fd1bc28	7
636522	guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	e95b5292-cd6c-4737-9386-f9441fd1bc28	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58602-810-12	58602081012	1 BOTTLE in 1 CARTON (58602-810-12) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2019-10-21	0000-00-00	No	No	Current
58602-810-21	58602081021	1 BOTTLE in 1 CARTON (58602-810-21) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2019-10-21	0000-00-00	No	No	Current
58602-810-38	58602081038	8 BLISTER PACK in 1 CARTON (58602-810-38) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	8 blister pack	2022-12-07		No	No	Current
58602-810-73	58602081073	1 BOTTLE in 1 CARTON (58602-810-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2019-10-21	0000-00-00	No	No	Current
58602-810-96	58602081096	1 BLISTER PACK in 1 CARTON (58602-810-96) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	1 blister pack	2019-10-21	0000-00-00	No	No	Current
58602-810-97	58602081097	2 BLISTER PACK in 1 CARTON (58602-810-97) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2 blister pack	2019-10-21	0000-00-00	No	No	Current
58602-810-98	58602081098	5 BLISTER PACK in 1 CARTON (58602-810-98) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	5 blister pack	2019-10-21	0000-00-00	No	No	Current