Guaifenesin

Product NDC: 65162-036
11-digit product format: 651620036
Labeler code: 65162
Product ID: 65162-036_f1b3934b-1fc2-4ce8-9465-e1f031daf9c5
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA207342
Marketing category: ANDA
Marketing start: 2018-07-27
Substance: GUAIFENESIN
Active strength: 600 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
A207342-001	GUAIFENESIN	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL			2018-07-11
A207342-002	GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL			2018-07-11

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	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Guaifenesin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	600 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
ad67e6fd-a68f-44db-9718-84a2cef86e09	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
65162-036-02	Guaifenesin	2 in 1 CARTON	TABLET, EXTENDED RELEASE	2	12
65162-036-02	Guaifenesin	10 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	10	12
65162-036-03	Guaifenesin	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	12
65162-036-03	Guaifenesin	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	12
65162-036-06	Guaifenesin	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	12
65162-036-06	Guaifenesin	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-036	GUAIFENESIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]	12	Current NDC, Legacy NDC, 6 package rows	20241027_ad67e6fd-a68f-44db-9718-84a2cef86e09.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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucus Relief Extended Release Maximum Strength	GUAIFENESIN	CVS Pharmacy	34314503-b253-4b44-96ff-a42fe2bb161f	2026-07-22	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief ER	GUAIFENESIN	Cardinal Health 107, LLC	f7abc2ff-21bc-48b5-9989-c5ac84f5c9cd	2026-07-21	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief	GUAIFENESIN	Rugby Laboratories	ee413595-2687-4c38-84ce-18aac933d8e3	2026-07-15	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief Extended Release	GUAIFENESIN	TARGET Corporation	e521e8e1-8227-451a-8858-01c26f6e0657	2026-07-06	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief	GUAIFENESIN	Harris Teeter, LLC	f7f2e64c-0fb9-413d-80ed-4d7cc2a07e0c	2026-05-01	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief Maximum Strength	GUAIFENESIN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	3ee82152-7c6f-4d93-909d-e1c50eee27e5	2026-04-20	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief	GUAIFENESIN	Best Choice (Valu Merchandisers Company)	9bac4bbb-a20c-48c5-891b-63f14a664d04	2026-04-15	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief Extended Release Maximum Strength	GUAIFENESIN	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	54a59e95-f95a-4bcd-ac9d-8d4ace85277f	2026-02-10	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief	GUAIFENESIN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	32f58b4a-3e1b-424f-8296-a9bf9a7d7025	2025-11-11	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief	GUAIFENESIN	Family Dollar (FAMILY WELLNESS)	1e1a9335-58ac-4722-9188-c847e62e7215	2025-11-05	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief	GUAIFENESIN	Family Dollar (FAMILY WELLNESS)	ddc18f31-acb2-4305-929a-f4746efd4224	2025-10-24	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief Extended Release Maximum Strength	GUAIFENESIN	Walgreens	e4b27b9b-5f3b-4314-9717-54d73cf6b74e	2025-08-28	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief	GUAIFENESIN	Rite Aid Corporation	73fb2194-a582-4d3c-bc82-c5f110efcd81	2025-08-20	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief Extended Release	GUAIFENESIN	Rugby Laboratories, Inc.	8bc6f08e-a941-4fa8-8dd6-a699abf2337d	2025-04-21	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief	GUAIFENESIN	H E B	efebda97-5234-451c-a854-91a32303a6b7	2025-03-17	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief ER	GUAIFENESIN	Major Pharmaceuticals	e5a242bf-3008-4c92-a930-e76f733be5cf	2025-03-07	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief	GUAIFENESIN	P & L Development, LLC	a2d14780-4a69-496e-86fe-7f2443cb0f20	2025-02-12	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief Extended Release	GUAIFENESIN	Redpharm Drug Inc.	f4c1e725-bcae-2255-e053-2995a90ad335	2025-01-23	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief	GUAIFENESIN	P & L Development, LLC	3c01a88f-35c8-4e43-9997-ebee7943820f	2024-11-14	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Guaifenesin	GUAIFENESIN	Amneal Pharmaceuticals LLC	ad67e6fd-a68f-44db-9718-84a2cef86e09	2024-10-07	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342 ndc (product): 65162-036

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	ad67e6fd-a68f-44db-9718-84a2cef86e09	12
636522	guaiFENesin 600 MG 12HR Extended Release Oral Tablet	PSN	ad67e6fd-a68f-44db-9718-84a2cef86e09	12
310621	12 HR guaifenesin 1200 MG Extended Release Oral Tablet	SCD	ad67e6fd-a68f-44db-9718-84a2cef86e09	12
636522	12 HR guaifenesin 600 MG Extended Release Oral Tablet	SCD	ad67e6fd-a68f-44db-9718-84a2cef86e09	12
310621	guaifenesin 1200 MG 12 HR Extended Release Oral Tablet	SY	ad67e6fd-a68f-44db-9718-84a2cef86e09	12
636522	guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	ad67e6fd-a68f-44db-9718-84a2cef86e09	12
636522	guaiFENesin 600 MG 12HR Extended Release Oral Tablet	PSN	efebda97-5234-451c-a854-91a32303a6b7	4
636522	12 HR guaifenesin 600 MG Extended Release Oral Tablet	SCD	efebda97-5234-451c-a854-91a32303a6b7	4
636522	guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	efebda97-5234-451c-a854-91a32303a6b7	4
636522	guaiFENesin 600 MG 12HR Extended Release Oral Tablet	PSN	f7f2e64c-0fb9-413d-80ed-4d7cc2a07e0c	3
636522	guaiFENesin 600 MG 12HR Extended Release Oral Tablet	PSN	3c01a88f-35c8-4e43-9997-ebee7943820f	3
636522	12 HR guaifenesin 600 MG Extended Release Oral Tablet	SCD	f7f2e64c-0fb9-413d-80ed-4d7cc2a07e0c	3
636522	12 HR guaifenesin 600 MG Extended Release Oral Tablet	SCD	3c01a88f-35c8-4e43-9997-ebee7943820f	3
636522	guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	f7f2e64c-0fb9-413d-80ed-4d7cc2a07e0c	3
636522	guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	3c01a88f-35c8-4e43-9997-ebee7943820f	3
636522	guaiFENesin 600 MG 12HR Extended Release Oral Tablet	PSN	3578086b-f961-4494-9bbd-530532048727	1
636522	12 HR guaifenesin 600 MG Extended Release Oral Tablet	SCD	3578086b-f961-4494-9bbd-530532048727	1
636522	guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	3578086b-f961-4494-9bbd-530532048727	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-036-02	65162003602	2 BLISTER PACK in 1 CARTON (65162-036-02) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2 blister pack	2018-07-27	0000-00-00	No	No	Current
65162-036-03	65162003603	1 BOTTLE in 1 CARTON (65162-036-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2018-07-27	0000-00-00	No	No	Current
65162-036-06	65162003606	1 BOTTLE in 1 CARTON (65162-036-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2018-07-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	P & L Development, LLC	2026-08-10	HUMAN OTC DRUG LABEL	4
Drug Facts	Harris Teeter, LLC	2026-05-01	HUMAN OTC DRUG LABEL	3
Drug Facts	H E B	2025-03-17	HUMAN OTC DRUG LABEL	4
Guaifenesin Extended-Release Tablets	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals of New York, LLC	2024-10-07	HUMAN OTC DRUG LABEL	12
Drug Facts	Strategic Sourcing Services LLC	2023-04-21	HUMAN OTC DRUG LABEL	1