Guaifenesin

Product NDC: 58602-811
11-digit product format: 586020811
Labeler code: 58602
Product ID: 58602-811_209f74eb-400d-40fe-943e-cecd8aec3a1d
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: 1200 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 ndc (product): 58602-811
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	1200 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
310621	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
c3533119-b307-4bad-8c79-254fea08402b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58602-811-01	Guaifenesin	14 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	14	8
58602-811-01	Guaifenesin	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	8
58602-811-02	Guaifenesin	2 in 1 CARTON	TABLET, EXTENDED RELEASE	2	8
58602-811-02	Guaifenesin	14 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	14	8
58602-811-03	Guaifenesin	14 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	14	8
58602-811-03	Guaifenesin	3 in 1 CARTON	TABLET, EXTENDED RELEASE	3	8
58602-811-05	Guaifenesin	14 in 1 BOTTLE	TABLET, EXTENDED RELEASE	14	8
58602-811-05	Guaifenesin	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	8
58602-811-12	Guaifenesin	40 in 1 BOTTLE	TABLET, EXTENDED RELEASE	40	8
58602-811-12	Guaifenesin	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	8
58602-811-21	Guaifenesin	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	8
58602-811-56	Guaifenesin	14 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	14	8
58602-811-56	Guaifenesin	4 in 1 CARTON	TABLET, EXTENDED RELEASE	4	8
58602-811-57	Guaifenesin	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	8
58602-811-57	Guaifenesin	28 in 1 BOTTLE	TABLET, EXTENDED RELEASE	28	8
58602-811-60	Guaifenesin	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	8
58602-811-60	Guaifenesin	42 in 1 BOTTLE	TABLET, EXTENDED RELEASE	42	8
58602-811-64	Guaifenesin	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	8
58602-811-64	Guaifenesin	7 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	7	8
58602-811-73	Guaifenesin	20 in 1 BOTTLE	TABLET, EXTENDED RELEASE	20	8
58602-811-73	Guaifenesin	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58602-811	GUAIFENESIN TABLET, EXTENDED RELEASE [AUROHEALTH LLC]	8	Current NDC, Legacy NDC, 21 package rows	20241102_c3533119-b307-4bad-8c79-254fea08402b.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
310621	guaiFENesin 1200 MG 12HR Extended Release Oral Tablet	PSN	c3533119-b307-4bad-8c79-254fea08402b	8
310621	12 HR guaifenesin 1200 MG Extended Release Oral Tablet	SCD	c3533119-b307-4bad-8c79-254fea08402b	8
310621	guaifenesin 1200 MG 12 HR Extended Release Oral Tablet	SY	c3533119-b307-4bad-8c79-254fea08402b	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58602-811-01	58602081101	1 BLISTER PACK in 1 CARTON (58602-811-01) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	1 blister pack	2019-10-21	0000-00-00	No	No	Current
58602-811-02	58602081102	2 BLISTER PACK in 1 CARTON (58602-811-02) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2 blister pack	2019-10-21	0000-00-00	No	No	Current
58602-811-03	58602081103	3 BLISTER PACK in 1 CARTON (58602-811-03) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	3 blister pack	2019-10-21	0000-00-00	No	No	Current
58602-811-05	58602081105	1 BOTTLE in 1 CARTON (58602-811-05) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2019-10-21	0000-00-00	No	No	Current
58602-811-12	58602081112	1 BOTTLE in 1 CARTON (58602-811-12) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2019-10-21	0000-00-00	No	No	Current
58602-811-21	58602081121	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-811-21)		2019-10-21	0000-00-00	No	No	Current
58602-811-56	58602081156	4 BLISTER PACK in 1 CARTON (58602-811-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	4 blister pack	2020-01-31	0000-00-00	No	No	Current
58602-811-57	58602081157	1 BOTTLE in 1 CARTON (58602-811-57) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2019-10-21	0000-00-00	No	No	Current
58602-811-60	58602081160	1 BOTTLE in 1 CARTON (58602-811-60) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2019-10-21	0000-00-00	No	No	Current
58602-811-64	58602081164	1 BLISTER PACK in 1 CARTON (58602-811-64) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	1 blister pack	2020-11-26	0000-00-00	No	No	Current
58602-811-73	58602081173	1 BOTTLE in 1 CARTON (58602-811-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2019-10-21	0000-00-00	No	No	Current