up and up mucus relief

Product NDC: 11673-421
11-digit product format: 116730421
Labeler code: 11673
Product ID: 11673-421_071469f4-4417-4729-8e75-1536c4dc422f
Type: HUMAN OTC DRUG
Nonproprietary name: guaifenesin
Dosage form: TABLET, MULTILAYER, EXTENDED RELEASE
Route: ORAL
Labeler: Target Corporation
Application: ANDA078912
Marketing category: ANDA
Marketing start: 2020-07-31
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: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	11673-421	11673-421-60	D	Discontinued by firm		2026-10-05

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
A078912-001	GUAIFENESIN	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL			2011-11-23
A078912-002	GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL			2020-11-05

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 · 81 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	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`bb7c543d1eb4…`

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: up and up mucus relief
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
7c1598f1-1236-48d2-861b-de4715e3f3d2	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
11673-421-01	up and up mucus relief	1 in 1 CARTON	TABLET, MULTILAYER, EXTENDED REL	1	5
11673-421-01	up and up mucus relief	20 in 1 BLISTER PACK	TABLET, MULTILAYER, EXTENDED REL	20	5
11673-421-60	up and up mucus relief	1 in 1 CARTON	TABLET, MULTILAYER, EXTENDED REL	1	5
11673-421-60	up and up mucus relief	20 in 1 BOTTLE	TABLET, MULTILAYER, EXTENDED REL	20	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11673-421	UP AND UP MUCUS RELIEF (GUAIFENESIN) TABLET, MULTILAYER, EXTENDED RELEASE [TARGET CORPORATION]	3	Current NDC, Legacy NDC, 4 package rows	20220601_7c1598f1-1236-48d2-861b-de4715e3f3d2.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 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DG health mucus er max	GUAIFENESIN	Dolgencorp Inc	4353d561-0e6d-4d36-b356-dd6506b5a3ee	2025-06-06	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
Topcare Mucus ER	GUAIFENESIN	Topco Associates LLC	b787eac7-8f87-49a2-899b-5f524eb7b1fc	2025-05-29	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
Guaifenesin Extended-Release	GUAIFENESIN	Precision Dose Inc.	608b00c5-a2c7-4514-9b46-02954d6675d6	2025-05-27	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
Leader Mucus Relief	GUAIFENESIN	Cardinal Health 110, LLC. dba Leader	34981e01-f405-4feb-807b-3a8c02faca96	2025-03-09	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
Topcare mucus er	GUAIFENESIN	Topco Associates LLC	e3c900ad-21b1-4cd0-8c48-f54f115df403	2024-12-12	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
DG Health Mucus ER	GUAIFENESIN	Dolgencorp, LLC	bf99fa83-c3be-4052-b5b6-ad91997cb034	2023-04-06	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
mucus	GUAIFENESIN	CVS Pharmacy	d6f1889e-8228-4c8c-a0e9-6c2afdc07e99	2023-01-25	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
basic care mucus er	GUAIFENESIN	Amazon.com Services LLC	14213a15-5842-456f-a5ab-654268c58f78	2022-04-11	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912

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
636522	guaiFENesin 600 MG 12HR Extended Release Oral Tablet	PSN	7c1598f1-1236-48d2-861b-de4715e3f3d2	5
636522	12 HR guaifenesin 600 MG Extended Release Oral Tablet	SCD	7c1598f1-1236-48d2-861b-de4715e3f3d2	5
636522	guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	7c1598f1-1236-48d2-861b-de4715e3f3d2	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11673-421-01	11673042101	1 BLISTER PACK in 1 CARTON (11673-421-01) / 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK	1 blister pack	2025-09-17		No	No	Current
11673-421-60	11673042160	1 BOTTLE in 1 CARTON (11673-421-60) > 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2020-07-31	0000-00-00	No	No	Current