Mucus Relief Extended Release

Product NDC: 11673-732
11-digit product format: 116730732
Labeler code: 11673
Product ID: 11673-732_4f1ef6de-331e-4faa-bb90-62b2e1ce4348
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: TABLET
Route: ORAL
Labeler: TARGET Corporation
Application: ANDA207342
Marketing category: ANDA
Marketing start: 2018-07-11
Marketing end: 2026-10-28
Substance: GUAIFENESIN
Active strength: 1200 mg/1
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag: No
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
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 · 86 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	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207342-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207342-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2018-07-11	`caaa826d4ba7…`
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…`

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: Mucus Relief Extended Release

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
e521e8e1-8227-451a-8858-01c26f6e0657	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11673-732-14	Mucus Relief Extended Release	1 in 1 BLISTER PACK	TABLET	1	3
11673-732-14	Mucus Relief Extended Release	14 in 1 CARTON	TABLET	14	3
11673-732-28	Mucus Relief Extended Release	1 in 1 BLISTER PACK	TABLET	1	3
11673-732-28	Mucus Relief Extended Release	28 in 1 CARTON	TABLET	28	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11673-732	MUCUS RELIEF EXTENDED RELEASE (GUAIFENESIN) TABLET [TARGET CORPORATION]	3	Current NDC, Legacy NDC, 4 package rows	20221118_e521e8e1-8227-451a-8858-01c26f6e0657.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 2 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucus Relief	GUAIFENESIN	United Natural Foods, Inc. dba UNFI	e7d457a6-05f9-407c-bf9b-a82e3cf2568c	2023-09-07	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief	GUAIFENESIN	Strategic Sourcing Services LLC	3578086b-f961-4494-9bbd-530532048727	2023-04-21	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief Extended Release Maximum Strength	GUAIFENESIN	H E B	6f075c29-8256-4cac-96c4-a772a53ad21d	2022-12-09	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief Extended Release	GUAIFENESIN	Care One (American Sales Company)	96569c70-0936-4041-ab32-2b2262402f34	2022-11-21	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief Maximum Strength	GUAIFENESIN	Care One (American Sales Company)	c94e3943-20da-4bd4-b0ff-6aa60b03a1bf	2022-11-21	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief	GUAIFENESIN	H E B	562b6ab6-4795-4909-8008-e919173844c9	2022-11-07	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342
Mucus Relief	GUAIFENESIN	WinCo Foods, LLC	90e72075-d08a-41c8-a6b0-5fbb99a7ea41	2022-05-11	Warnings	Exact identifier application applno (ANDA): 207342 application number: ANDA207342

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	e521e8e1-8227-451a-8858-01c26f6e0657	3
310621	12 HR guaifenesin 1200 MG Extended Release Oral Tablet	SCD	e521e8e1-8227-451a-8858-01c26f6e0657	3
310621	guaifenesin 1200 MG 12 HR Extended Release Oral Tablet	SY	e521e8e1-8227-451a-8858-01c26f6e0657	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11673-732-14	11673073214	14 BLISTER PACK in 1 CARTON (11673-732-14) / 1 TABLET in 1 BLISTER PACK	14 blister pack	2018-07-11	2026-10-28	No	No	Current
11673-732-28	11673073228	28 BLISTER PACK in 1 CARTON (11673-732-28) / 1 TABLET in 1 BLISTER PACK	28 blister pack	2018-07-11	2026-10-28	No	No	Current