Guaifenesin

Product NDC: 68196-996
11-digit product format: 681960996
Labeler code: 68196
Product ID: 68196-996_1cb900ed-18b4-4999-a149-0b4667abcda1
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: SAM'S WEST INC
Application: ANDA209254
Marketing category: ANDA
Marketing start: 2022-01-12
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
A209254-001	GUAIFENESIN	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL			2018-07-16
A209254-002	GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL			2018-07-16

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	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209254-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209254-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-16	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Guaifenesin
Brand name suffix: Extended Release
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
64297bb8-cd4e-46d3-ae79-ea4aa4c03bca	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
68196-996-56	GuaifenesinExtended Release	14 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	14		4
68196-996-56	GuaifenesinExtended Release	4 in 1 CARTON	TABLET, EXTENDED RELEASE	4		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68196-996	GUAIFENESIN EXTENDED RELEASE (GUAIFENESIN) TABLET, EXTENDED RELEASE [SAM'S WEST INC]	4	Current NDC, Legacy NDC, 2 package rows	20220626_64297bb8-cd4e-46d3-ae79-ea4aa4c03bca.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Guaifenesin	GUAIFENESIN	Ohm Laboratories, Inc.	7076e42a-17ff-4c42-9963-2dc02c0a5e49	2026-02-12	Warnings	Exact identifier application applno (ANDA): 209254 application number: ANDA209254
Guaifenesin Extended Release	GUAIFENESIN	PUBLIX SUPER MARKETS, INC	038e1801-b978-4a2e-ae8c-8803596ec09c	2025-05-20	Warnings	Exact identifier application applno (ANDA): 209254 application number: ANDA209254
GUAIFENESIN	GUAIFENESIN	Publix Super Markets, Inc	435e627c-b4f4-4214-904a-7527aab32cbf	2025-05-20	Warnings	Exact identifier application applno (ANDA): 209254 application number: ANDA209254
Guaifenesin	GUAIFENESIN	AMERISOURCE BERGEN	d1d94d37-4423-4914-9d86-c5ca6d5122f6	2025-04-22	Warnings	Exact identifier application applno (ANDA): 209254 application number: ANDA209254
GUAIFENESIN	GUAIFENESIN	CVS	4efa8bf9-3394-47b4-b630-9476b15d2dfc	2022-11-23	Warnings	Exact identifier application applno (ANDA): 209254 application number: ANDA209254
Guaifenesin Extended Release	GUAIFENESIN	SAM'S WEST INC	64297bb8-cd4e-46d3-ae79-ea4aa4c03bca	2022-06-24	Warnings	Exact identifier application applno (ANDA): 209254 application number: ANDA209254 ndc (product): 68196-996
GUAIFENESIN	GUAIFENESIN	Walmart Stores, Inc.	794e383d-2cae-49d7-9c2d-ae5547bde536	2022-05-09	Warnings	Exact identifier application applno (ANDA): 209254 application number: ANDA209254
GUAIFENESIN	GUAIFENESIN	Kroger Company	d1ffd899-2a2a-41c0-b0c0-7c42f8cabf8d	2022-04-29	Warnings	Exact identifier application applno (ANDA): 209254 application number: ANDA209254
Guaifenesin Extended Release	GUAIFENESIN	Kroger Company	d434656a-221b-40fc-81ad-2b698be1aa33	2022-04-20	Warnings	Exact identifier application applno (ANDA): 209254 application number: ANDA209254

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	64297bb8-cd4e-46d3-ae79-ea4aa4c03bca	4
310621	12 HR guaifenesin 1200 MG Extended Release Oral Tablet	SCD	64297bb8-cd4e-46d3-ae79-ea4aa4c03bca	4
310621	guaifenesin 1200 MG 12 HR Extended Release Oral Tablet	SY	64297bb8-cd4e-46d3-ae79-ea4aa4c03bca	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68196-996-56	68196099656	4 BLISTER PACK in 1 CARTON (68196-996-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	4 blister pack	2022-01-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Guaifenesin Extended Release	SAM'S WEST INC \| Ohm Laboratories Inc.	2022-06-24	HUMAN OTC DRUG LABEL	4