Mucus Relief ER

Product NDC: 0904-6718
Requested package NDC: 0904-6718-39
11-digit product format: 009046718
Labeler code: 0904
Product ID: 0904-6718_ebcfe516-e74c-4f97-8ade-85cfbadf4f33
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA207342
Marketing category: ANDA
Marketing start: 2018-09-30
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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (package): 0904-6718-39 ndc (product): 0904-6718 ndc11 (package): 00904671839
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

Additional Listing Data#

Finished product: Yes
Brand name base: Mucus Relief ER
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 · 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
e5a242bf-3008-4c92-a930-e76f733be5cf	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-6718-39	Mucus Relief ER	1 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	1		6
0904-6718-39	Mucus Relief ER	100 in 1 CARTON	TABLET, EXTENDED RELEASE	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6718-39	EA - Each	0904-6718	d92d08de-0344-44fe-b4c0-e7f1ab2254bd	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6718	MUCUS RELIEF ER (GUAIFENESIN) TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]	6	Current NDC, Legacy NDC, 2 package rows	20250313_e5a242bf-3008-4c92-a930-e76f733be5cf.zip

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	e5a242bf-3008-4c92-a930-e76f733be5cf	6
636522	12 HR guaifenesin 600 MG Extended Release Oral Tablet	SCD	e5a242bf-3008-4c92-a930-e76f733be5cf	6
636522	guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	e5a242bf-3008-4c92-a930-e76f733be5cf	6
636522	guaiFENesin 600 MG 12HR Extended Release Oral Tablet	PSN	f7abc2ff-21bc-48b5-9989-c5ac84f5c9cd	5
636522	12 HR guaifenesin 600 MG Extended Release Oral Tablet	SCD	f7abc2ff-21bc-48b5-9989-c5ac84f5c9cd	5
636522	guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	f7abc2ff-21bc-48b5-9989-c5ac84f5c9cd	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6718-39	00904671839	100 BLISTER PACK in 1 CARTON (0904-6718-39) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	100 blister pack	2018-09-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Cardinal Health 107, LLC	2026-07-21	HUMAN OTC DRUG LABEL	7
Drug Facts	Major Pharmaceuticals	2025-03-07	HUMAN OTC DRUG LABEL	6