Guaifenesin 1200 mg

Product NDC: 25000-041
11-digit product format: 250000041
Labeler code: 25000
Product ID: 25000-041_0af3bdb4-c1f3-4941-a1de-6e08c49849cb
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin 1200 mg
Dosage form: TABLET
Route: ORAL
Labeler: MARKSANS PHARMA LIMITED
Application: ANDA217780
Marketing category: ANDA
Marketing start: 2023-08-23
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
A217780-001	GUAIFENESIN	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL			2023-08-21
A217780-002	GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL			2023-08-21

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.

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	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Guaifenesin 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310621	Internal RxNorm lookup
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
fedf43d0-d6d1-4f50-bbab-396701e45cb2	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
25000-041-12	Guaifenesin 1200 mg	500 in 1 BOTTLE	TABLET	500	6
25000-041-34	Guaifenesin 1200 mg	2 in 1 CARTON	TABLET	2	6
25000-041-34	Guaifenesin 1200 mg	14 in 1 BLISTER PACK	TABLET	14	6
25000-041-75	Guaifenesin 1200 mg	2 in 1 CARTON	TABLET	2	6
25000-041-75	Guaifenesin 1200 mg	6 in 1 BLISTER PACK	TABLET	6	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25000-041	GUAIFENESIN 600 MG TABLET GUAIFENESIN 1200 MG TABLET [MARKSANS PHARMA LIMITED]	4	Current NDC, 5 package rows	20250426_fedf43d0-d6d1-4f50-bbab-396701e45cb2.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 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucus Relief	GUAIFENESIN	CVS Pharmacy	2cfbb804-de2b-5b2f-e063-6394a90a0824	2026-04-28	Warnings	Exact identifier application applno (ANDA): 217780 application number: ANDA217780
Mucus Relief	GUAIFENESIN	Grocery Outlet, Inc.	4466623c-6387-e725-e063-6394a90ad95e	2026-03-14	Warnings	Exact identifier application applno (ANDA): 217780 application number: ANDA217780
Guaifenesin 1200 mg	GUAIFENESIN 1200 MG	MARKSANS PHARMA LIMITED	fedf43d0-d6d1-4f50-bbab-396701e45cb2	2025-10-17	Warnings	Exact identifier application applno (ANDA): 217780 application number: ANDA217780 ndc (product): 25000-041
Mucus Relief	GUAIFENESIN	BJWC (Berkley & Jensen / BJ's)	2f32e8f9-260c-fa36-e063-6294a90a953d	2025-08-19	Warnings	Exact identifier application applno (ANDA): 217780 application number: ANDA217780
Maximum Strength Mucus Relief	GUAIFENESIN	SAM'S WEST INC	39282544-e1e8-8270-e063-6394a90a23fe	2025-08-13	Warnings	Exact identifier application applno (ANDA): 217780 application number: ANDA217780
Mucus Relief ER	GUAIFENESIN	Rugby Laboratories	2e6901aa-16f6-9b73-e063-6294a90a4d72	2025-08-02	Warnings	Exact identifier application applno (ANDA): 217780 application number: ANDA217780
Mucus Relief	GUAIFENESIN	LEADER/ Cardinal Health 110, Inc.	3099ac87-e61f-2f56-e063-6294a90aa891	2025-04-16	Warnings	Exact identifier application applno (ANDA): 217780 application number: ANDA217780
Maximum Strength Mucus Relief	GUAIFENESIN	KROGER COMPANY	100ff8e2-88ed-0e8c-e063-6294a90a5716	2024-05-25	Warnings	Exact identifier application applno (ANDA): 217780 application number: ANDA217780
Mucus Relief	GUAIFENESIN	KROGER COMPANY	100f59fb-f9e7-5acb-e063-6394a90af450	2024-05-21	Warnings	Exact identifier application applno (ANDA): 217780 application number: ANDA217780
Guaifenesin Extended Release 600 mg	GUAIFENESIN	TIME CAP LABORATORIES, INC.	10c42869-7df0-3046-e063-6394a90aa679	2024-02-07	Warnings	Exact identifier application applno (ANDA): 217780 application number: ANDA217780

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	fedf43d0-d6d1-4f50-bbab-396701e45cb2	6
636522	guaiFENesin 600 MG 12HR Extended Release Oral Tablet	PSN	fedf43d0-d6d1-4f50-bbab-396701e45cb2	6
310621	12 HR guaifenesin 1200 MG Extended Release Oral Tablet	SCD	fedf43d0-d6d1-4f50-bbab-396701e45cb2	6
636522	12 HR guaifenesin 600 MG Extended Release Oral Tablet	SCD	fedf43d0-d6d1-4f50-bbab-396701e45cb2	6
310621	guaifenesin 1200 MG 12 HR Extended Release Oral Tablet	SY	fedf43d0-d6d1-4f50-bbab-396701e45cb2	6
636522	guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	fedf43d0-d6d1-4f50-bbab-396701e45cb2	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
25000-041-12	25000004112	500 TABLET in 1 BOTTLE (25000-041-12)	500 tablet	2023-08-23	No	No	Current
25000-041-34	25000004134	2 BLISTER PACK in 1 CARTON (25000-041-34) / 14 TABLET in 1 BLISTER PACK	2 blister pack	2025-04-18	No	No	Current
25000-041-75	25000004175	2 BLISTER PACK in 1 CARTON (25000-041-75) / 6 TABLET in 1 BLISTER PACK	2 blister pack	2023-08-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Guaifenesin Extended-Release Tablets 600 mg and 1200 mg	MARKSANS PHARMA LIMITED	2025-10-17	Human OTC Drug Label	6