Guaifenesin Extended-Release 1200 mg

Product NDC: 53041-234
11-digit product format: 530410234
Labeler code: 53041
Product ID: 53041-234_8186c3e8-1ae5-459d-8771-ad2d1ae95387
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Guardian Drug Company
Application: ANDA209215
Marketing category: ANDA
Marketing start: 2018-03-01
Substance: GUAIFENESIN
Active strength: 1200 mg/1
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
A209215-001	GUAIFENESIN	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL			2017-09-06
A209215-002	GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL			2017-09-06

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 3 · 82 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	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Guaifenesin Extended-Release 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
20f9e083-419d-429d-a570-24b312ed5d2a	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
53041-234-37	Guaifenesin Extended-Release 1200 mg	4 in 1 CARTON	TABLET, EXTENDED RELEASE	4	2
53041-234-37	Guaifenesin Extended-Release 1200 mg	7 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	7	2
53041-234-47	Guaifenesin Extended-Release 1200 mg	7 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	7	2
53041-234-47	Guaifenesin Extended-Release 1200 mg	6 in 1 CARTON	TABLET, EXTENDED RELEASE	6	2
53041-234-58	Guaifenesin Extended-Release 1200 mg	7 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	7	2
53041-234-58	Guaifenesin Extended-Release 1200 mg	2 in 1 CARTON	TABLET, EXTENDED RELEASE	2	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53041-234	GUAIFENESIN EXTENDED-RELEASE 600 MG (GUAIFENESIN) TABLET, EXTENDED RELEASE GUAIFENESIN EXTENDED-RELEASE 1200 MG (GUAIFENESIN) TABLET, EXTENDED RELEASE [GUARDIAN DRUG COMPANY]	2	Current NDC, Legacy NDC, 6 package rows	20180301_20f9e083-419d-429d-a570-24b312ed5d2a.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Guaifenesin	GUAIFENESIN	YYBA CORP	4cb11551-31e3-5c01-e063-6394a90ab0d4	2026-06-24	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
MUCUS RELIEF	GUAIFENESIN	YYBA Corp	5074b172-311b-43e2-e063-6394a90aa70f	2026-06-22	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Mucus Relief	GUAIFENESIN	NCS HealthCare of KY, LLC dba Vangard Labs	41f4f8df-87d4-459f-af6d-3a4356a8115b	2026-06-04	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Foster and Thrive Mucus Relief	GUAIFENESIN	Strategic Sourcing Services LLC	f4ab5611-8abb-4c1f-8f85-917e2e1328e3	2026-03-04	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Topco Mucus Relief	GUAIFENESIN	Topco Associates, LLC	03c17c06-6919-4ef4-9d0a-4c039940c671	2025-12-03	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Mucus Relief	GUAIFENESIN	Major Pharmaceuticals	4d98920b-caf7-42d9-bd08-859d27b6d76a	2025-11-24	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Mucus Relief	GUAIFENESIN	Bryant Ranch Prepack	c648e711-e944-4574-83b3-ccce8732384e	2025-06-02	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Mucus Relief Max	GUAIFENESIN	Discount Drug Mart, Inc	2df7e36d-8eb6-827b-e063-6294a90acb1d	2025-02-24	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Mucus Relief	GUAIFENESIN	Discount Drug Mart, Inc	2d5940b8-fdae-edf2-e063-6294a90a68fc	2025-02-24	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Guaifenesin Extended Release 600 mg	GUAIFENESIN	Wal-Mart Stores, Inc.	1769c98d-8bce-6bf5-e063-6394a90a6442	2024-10-22	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Mucus Relief 600 mg	GUAIFENESIN	Guardian Drug Company	e7742a43-9066-4e28-a90d-f07c0e18f045	2024-04-30	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Equate Mucus Relief	GUAIFENESIN	Wal-Mart Stores, Inc.	516c76ac-5e2d-41f9-81bd-20e05f0b2300	2024-04-09	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Mucus Relief	GUAIFENESIN	McKesson Corporation dba SKY Packaging	69b61f05-8f0b-420f-b4ef-df933b70eebc	2022-11-21	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Mucus Relief	GUAIFENESIN	Aphena Pharma Solutions - Tennessee, LLC	01af03f1-5d1b-4893-b7db-7092ba66e842	2021-05-03	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Guaifenesin Extended-Release 600 mg	GUAIFENESIN	Guardian Drug Company	20f9e083-419d-429d-a570-24b312ed5d2a	2018-02-28	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215 ndc (product): 53041-234

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	20f9e083-419d-429d-a570-24b312ed5d2a	2
636522	guaiFENesin 600 MG 12HR Extended Release Oral Tablet	PSN	20f9e083-419d-429d-a570-24b312ed5d2a	2
310621	12 HR guaifenesin 1200 MG Extended Release Oral Tablet	SCD	20f9e083-419d-429d-a570-24b312ed5d2a	2
636522	12 HR guaifenesin 600 MG Extended Release Oral Tablet	SCD	20f9e083-419d-429d-a570-24b312ed5d2a	2
310621	guaifenesin 1200 MG 12 HR Extended Release Oral Tablet	SY	20f9e083-419d-429d-a570-24b312ed5d2a	2
636522	guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	20f9e083-419d-429d-a570-24b312ed5d2a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53041-234-37	53041023437	4 BLISTER PACK in 1 CARTON (53041-234-37) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	4 blister pack	2018-03-01	0000-00-00	No	No	Current
53041-234-47	53041023447	6 BLISTER PACK in 1 CARTON (53041-234-47) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	6 blister pack	2018-03-01	0000-00-00	No	No	Current
53041-234-58	53041023458	2 BLISTER PACK in 1 CARTON (53041-234-58) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2 blister pack	2018-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Guaifenesin Extended Release Tablets 600 mg and 1200 mg	Guardian Drug Company	2018-02-28	Human OTC Drug Label	2