GUAIFENESIN - ODAAT

Product NDC: 83139-175
11-digit product format: 831390175
Labeler code: 83139
Product ID: 83139-175_f61d3ae0-11ec-2a82-e053-2995a90a95da
Type: HUMAN OTC DRUG
Nonproprietary name: GUAIFENESIN
Dosage form: TABLET
Route: ORAL
Labeler: LODAAT LLC
Application: ANDA213420
Marketing category: ANDA
Marketing start: 2023-03-04
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 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 - ODAAT
Brand name suffix: 1200 MG
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
f61d3ae0-11eb-2a82-e053-2995a90a95da	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83139-175-01	GUAIFENESIN - ODAAT1200 MG	100 in 1 BOTTLE	TABLET	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83139-175	GUAIFENESIN - ODAAT 1200 MG (GUAIFENESIN) TABLET [LODAAT LLC]	1	Current NDC, 1 package rows	20230307_f61d3ae0-11eb-2a82-e053-2995a90a95da.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
Curist Mucus Relief Maximum Strength	GUAIFENESIN	Little Pharma, Inc.	c7d1136c-a712-2ac5-e053-2995a90a4dd4	2026-08-24	Warnings	Exact identifier application applno (ANDA): 213420 application number: ANDA213420
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
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
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	f61d3ae0-11eb-2a82-e053-2995a90a95da	1
310621	12 HR guaifenesin 1200 MG Extended Release Oral Tablet	SCD	f61d3ae0-11eb-2a82-e053-2995a90a95da	1
310621	guaifenesin 1200 MG 12 HR Extended Release Oral Tablet	SY	f61d3ae0-11eb-2a82-e053-2995a90a95da	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83139-175-01	83139017501	100 TABLET in 1 BOTTLE (83139-175-01)	100 tablet	2023-03-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LODAAT- GUAIFENESIN - ODAAT 1200 mg CAPLETS (83139-175)	LODAAT LLC	2023-03-04	HUMAN OTC DRUG LABEL	1