Guaifenesin

Product NDC: 69848-017
11-digit product format: 698480017
Labeler code: 69848
Product ID: 69848-017_46909531-34b7-b81b-e063-6394a90a8515
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: GRANULES USA, INC.
Application: ANDA213420
Marketing category: ANDA
Marketing start: 2021-12-31
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 43.

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
A213420-001	GUAIFENESIN	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL			2020-05-08
A213420-002	GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL			2020-05-08

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
2026-09-14 22:38:34	2026-08	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
a62d427e-f339-f225-e053-2a95a90ab387	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	Strength	SPL version
69848-017-02	Guaifenesin	20 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	20		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69848-017	GUAIFENESIN TABLET, EXTENDED RELEASE [GRANULES USA, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20241212_a62d427e-f339-f225-e053-2a95a90ab387.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 2 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GUAIFENESIN	GUAIFENESIN	Granules India Ltd	e3531e9e-2ae7-4188-b95a-90f35613fc05	2025-12-02	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 1200 mg	GUAIFENESIN	YYBA CORP	d9d2539b-bd31-66bd-e053-2a95a90aa583	2025-11-27	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mg	GUAIFENESIN	YYBA CORP	d9d1ce2d-d96a-4950-e053-2995a90ad988	2025-11-27	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Mucus Relief	GUAIFENESIN	AMERIFOODS TRADING COMPANY	3802d63d-7dba-50de-e063-6294a90acf7b	2025-11-20	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
GUAIFENESIN	GUAIFENESIN	Granules India Ltd	ba7c1e26-b7d0-4aea-e053-2a95a90a903e	2025-10-16	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
GUAIFENESIN	GUAIFENESIN	Advanced Rx LLC	cb7cd1df-8cfb-4a9c-9567-809a2343622e	2025-07-01	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Mucus Relief	GUAIFENESIN	Meijer	2d7aa3c1-5a4f-7197-e063-6394a90aff47	2025-05-21	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
mucus relief	GUAIFENESIN	Meijer Distribution Inc	a0510998-d297-4222-857c-c8e80c657ddf	2025-05-08	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Mucus Relief	GUAIFENESIN	Bi-Mart	41da5f65-a662-4353-9e44-21ba35fb1534	2025-05-01	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
MUCUS RELIEF	GUAIFENESIN	Bi-Mart	d995a6a5-d68b-44e4-9281-32c5417fb5e3	2025-04-01	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Curist Mucus Relief	GUAIFENESIN	Little Pharma, Inc.	d8892a82-25a7-552d-e053-2a95a90a72fd	2025-02-27	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
12 Hour Mucus Relief	GUAIFENESIN	CHAIN DRUG MARKETING ASSOCIATION INC	0d3b8e23-90d2-431b-a395-a9ddf2457e64	2024-10-11	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Maximum Strength Mucus Relief	GUAIFENESIN	CHAIN DRUG MARKETING ASSOCIATION INC	c20f64e3-485b-4ea7-b73d-56e5c898ed2e	2024-10-11	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Mucus Relief	GUAIFENESIN	Advanced Rx LLC	6046a5c6-96b1-4c20-acac-2716025c1665	2024-08-29	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Mucus Relief	GUAIFENESIN	CHAIN DRUG MARKETING ASSOCIATION, INC.	1445433b-69bc-487c-aa5a-e4ac7f5bef21	2024-08-07	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Mucus Relief	GUAIFENESIN	CHAIN DRUG MARKETING ASSOCIATION, INC.	b630357a-4166-4b30-8137-47ca3d579e79	2024-07-18	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
GUAIFENESIN	GUAIFENESIN	GRANULES PHARMACEUTICALS INC.	e6994e38-2a21-4bcf-e053-2995a90a0854	2024-07-08	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Mucus Relief	GUAIFENESIN	HARRIS TEETER	114a858c-a021-8915-e063-6394a90afdcf	2024-06-14	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Mucus Relief Maximum Strength	GUAIFENESIN	HARRIS TEETER	114a8c26-25be-5a0b-e063-6294a90a3e18	2024-06-14	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Mucus Relief	GUAIFENESIN	AAA Pharmaceutical, Inc.	68d6b88a-85ed-414d-8369-c7cceb8e9780	2024-06-13	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420

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	a62d427e-f339-f225-e053-2a95a90ab387	5
636522	12 HR guaifenesin 600 MG Extended Release Oral Tablet	SCD	a62d427e-f339-f225-e053-2a95a90ab387	5
636522	guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	a62d427e-f339-f225-e053-2a95a90ab387	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69848-017-02	69848001702	20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (69848-017-02)	2022-01-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Guaifenesin Extended-Release Tablets 600 mg Expectorant 12 HR	GRANULES USA, INC.	2025-12-22	HUMAN OTC DRUG LABEL	5