Guaifenesin

Product NDC: 0363-0570
11-digit product format: 003630570
Labeler code: 0363
Product ID: 0363-0570_46543546-17f6-6061-e063-6294a90a2e18
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: TABLET
Route: ORAL
Labeler: Walgreens
Application: ANDA213420
Marketing category: ANDA
Marketing start: 2024-06-13
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
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 · 74 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	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…`
2021-12-28 21:50 UTC	2021-12	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`87673890dc5c…`

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
fd913bc8-9e1e-3a63-e053-6394a90a34fb	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0363-0570-27	Guaifenesin	14 in 1 BLISTER PACK	TABLET	14		4
0363-0570-28	Guaifenesin	28 in 1 BLISTER PACK	TABLET	28		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0570	GUAIFENESIN TABLET [WALGREENS]	3	Current NDC, 2 package rows	20241222_fd913bc8-9e1e-3a63-e053-6394a90a34fb.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 3 · 58 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topcare Mucus ER	GUAIFENESIN	Topco Associates LLC	916de841-b1eb-4f00-9e25-1d2e4ab0c6e9	2026-06-18	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Dr. Simi Mucus Relief	GUAIFENESIN	Farmacias De Similares TX LLC	4ef7dae3-9081-bc3b-e063-6294a90a9a75	2026-04-08	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
MUCUS RELIEF GUAIFENESIN EXTENDED-RELEASE 600 mg	GUAIFENESIN	TWIN MED LLC	d9d13c67-51a1-aa79-e053-2995a90abdbb	2026-03-26	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
good neighbor pharmacy mucus er	GUAIFENESIN	Amerisource Bergen	41b4a15d-f5a7-4c45-b950-0aa6b093be1c	2026-03-12	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Curist Mucus Relief Maximum Strength	GUAIFENESIN	Little Pharma, Inc.	c7d1136c-a712-2ac5-e053-2995a90a4dd4	2026-03-03	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
GUAIFENESIN	GUAIFENESIN	Proficient Rx LP	28b31f37-6896-40f5-8f3a-60c93c5c1278	2026-02-01	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Mucus Relief	GUAIFENESIN	HYVEE INC	462cb425-1fdf-0623-e063-6294a90abd18	2026-01-13	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Guaifenesin	GUAIFENESIN	GRANULES USA, INC.	a62d427e-f339-f225-e053-2a95a90ab387	2025-12-22	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Guaifenesin	GUAIFENESIN	GRANULES USA, INC.	a62e2045-8ec2-1771-e053-2995a90a03b4	2025-12-22	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Mucus Relief	GUAIFENESIN	Pioneer Life Sciences, LLC	be8ec612-41a8-479e-a889-7e09f2d27c10	2025-12-22	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Guaifenesin	GUAIFENESIN	Safeway, Inc	f32e5b0f-1fd9-9b33-e053-2995a90a8103	2025-12-19	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Guaifenesin	GUAIFENESIN	TARGET CORPORATION	09957814-61e2-4488-e063-6294a90a2201	2025-12-19	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Guaifenesin	GUAIFENESIN	TARGET CORPORATION	0a0aa190-8dc7-f9cc-e063-6394a90a6078	2025-12-19	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Guaifenesin	GUAIFENESIN	SAM'S WEST INC	00c40e3b-6962-dfb4-e063-6294a90afec6	2025-12-19	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Guaifenesin	GUAIFENESIN	CVS PHARMACY, INC	bdaf7359-8698-87d6-e053-2a95a90ada28	2025-12-19	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Guaifenesin	GUAIFENESIN	Walgreens	fd913bc8-9e1e-3a63-e053-6394a90a34fb	2025-12-19	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420 ndc (product): 0363-0570
Guaifenesin	GUAIFENESIN	Walgreens	fd91621b-c969-8851-e053-6294a90ad8b2	2025-12-19	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Mucus Relief	GUAIFENESIN	NUVICARE LLC	a6608a39-2023-4953-a7c3-1764a6b215a3	2025-12-16	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Mucus Relief	GUAIFENESIN	NUVICARE LLC	d6734345-29a1-4356-a063-ff37ed4fbe9a	2025-12-05	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
Mucus Relief	GUAIFENESIN	Pioneer Life Sciences, LLC	d635b228-a51f-42d9-885c-3cd566fd352b	2025-12-04	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
310621	guaiFENesin 1200 MG 12HR Extended Release Oral Tablet	PSN	fd913bc8-9e1e-3a63-e053-6394a90a34fb	4
310621	12 HR guaifenesin 1200 MG Extended Release Oral Tablet	SCD	fd913bc8-9e1e-3a63-e053-6394a90a34fb	4
310621	guaifenesin 1200 MG 12 HR Extended Release Oral Tablet	SY	fd913bc8-9e1e-3a63-e053-6394a90a34fb	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0363-0570-27	00363057027	14 TABLET in 1 BLISTER PACK (0363-0570-27)	14 tablet	2024-06-13	No	No	Current
0363-0570-28	00363057028	28 TABLET in 1 BLISTER PACK (0363-0570-28)	28 tablet	2024-06-13	No	No	Current