Mucus Relief Extended Release

Product NDC: 55315-732
Requested package NDC: 55315-732-14
11-digit product format: 553150732
Labeler code: 55315
Product ID: 55315-732_ec708689-613e-4e80-bc96-32abea56e6b1
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: TABLET
Route: ORAL
Labeler: Freds Inc
Application: ANDA207342
Marketing category: ANDA
Marketing start: 2019-02-28
Marketing end: 0000-00-00
Substance: GUAIFENESIN
Active strength: 1200 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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	55315-732	55315-732-14	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2020-10-27	Drug Facts
2020-09-27	Drug Facts
2020-09-25	Drug Facts
2020-07-22	Drug Facts

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55315-732-14	55315073214	14 BLISTER PACK in 1 CARTON (55315-732-14) > 1 TABLET in 1 BLISTER PACK	14 blister pack	2019-02-28	0000-00-00	No	No	Current