Mucus Relief

Product NDC: 67296-1804
11-digit product format: 672961804
Labeler code: 67296
Product ID: 67296-1804_d61ce253-b396-18cb-e053-2995a90a4bbf
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: RedPharm Drug
Application: ANDA209215
Marketing category: ANDA
Marketing start: 2019-09-23
Marketing end: 0000-00-00
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: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	67296-1804		I	Inactivated by FDA		2026-08-17
excluded package	package	67296-1804	67296-1804-7	I	Inactivated by FDA		2026-08-17

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67296-1804-7	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-1804-7	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-1804-7	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-1804-7	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A209215-001	GUAIFENESIN	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL			2017-09-06
A209215-002	GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL			2017-09-06

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209215-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209215-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2017-09-06	`bb7c543d1eb4…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-1804-7	2024-07-25	C162847	48780-1	1030e365-673e-111a-e063-dadaa90a10e2	MUCUS RELIEF 600mg
67296-1804-7	2024-01-30	C162847	48780-1	1030e365-673e-111a-e063-dadaa90a10e2	MUCUS RELIEF 600mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1804-7	Mucus Relief	14 in 1 BOTTLE	TABLET, EXTENDED RELEASE	14		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1804	MUCUS RELIEF (GUAIFENESIN) TABLET, EXTENDED RELEASE [REDPHARM DRUG]	5	Legacy NDC, 1 package rows	20240727_b2e85973-2179-5a21-e053-2a95a90ad6bb.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 1 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Guaifenesin	GUAIFENESIN	YYBA CORP	4cb11551-31e3-5c01-e063-6394a90ab0d4	2026-06-24	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
MUCUS RELIEF	GUAIFENESIN	YYBA Corp	5074b172-311b-43e2-e063-6394a90aa70f	2026-06-22	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Mucus Relief	GUAIFENESIN	NCS HealthCare of KY, LLC dba Vangard Labs	41f4f8df-87d4-459f-af6d-3a4356a8115b	2026-06-04	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Foster and Thrive Mucus Relief	GUAIFENESIN	Strategic Sourcing Services LLC	f4ab5611-8abb-4c1f-8f85-917e2e1328e3	2026-03-04	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Topco Mucus Relief	GUAIFENESIN	Topco Associates, LLC	03c17c06-6919-4ef4-9d0a-4c039940c671	2025-12-03	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Mucus Relief	GUAIFENESIN	Major Pharmaceuticals	4d98920b-caf7-42d9-bd08-859d27b6d76a	2025-11-24	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Mucus Relief	GUAIFENESIN	Bryant Ranch Prepack	c648e711-e944-4574-83b3-ccce8732384e	2025-06-02	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Mucus Relief Max	GUAIFENESIN	Discount Drug Mart, Inc	2df7e36d-8eb6-827b-e063-6294a90acb1d	2025-02-24	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Mucus Relief	GUAIFENESIN	Discount Drug Mart, Inc	2d5940b8-fdae-edf2-e063-6294a90a68fc	2025-02-24	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Guaifenesin Extended Release 600 mg	GUAIFENESIN	Wal-Mart Stores, Inc.	1769c98d-8bce-6bf5-e063-6394a90a6442	2024-10-22	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Mucus Relief 600 mg	GUAIFENESIN	Guardian Drug Company	e7742a43-9066-4e28-a90d-f07c0e18f045	2024-04-30	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Equate Mucus Relief	GUAIFENESIN	Wal-Mart Stores, Inc.	516c76ac-5e2d-41f9-81bd-20e05f0b2300	2024-04-09	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Mucus Relief	GUAIFENESIN	McKesson Corporation dba SKY Packaging	69b61f05-8f0b-420f-b4ef-df933b70eebc	2022-11-21	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Mucus Relief	GUAIFENESIN	Aphena Pharma Solutions - Tennessee, LLC	01af03f1-5d1b-4893-b7db-7092ba66e842	2021-05-03	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215
Guaifenesin Extended-Release 600 mg	GUAIFENESIN	Guardian Drug Company	20f9e083-419d-429d-a570-24b312ed5d2a	2018-02-28	Warnings	Exact identifier application applno (ANDA): 209215 application number: ANDA209215

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	b2e85973-2179-5a21-e053-2a95a90ad6bb	5
636522	12 HR guaifenesin 600 MG Extended Release Oral Tablet	SCD	b2e85973-2179-5a21-e053-2a95a90ad6bb	5
636522	guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	b2e85973-2179-5a21-e053-2a95a90ad6bb	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1804-7	67296180407	14 TABLET, EXTENDED RELEASE in 1 BOTTLE (67296-1804-7)	2019-09-23	0000-00-00	No	No	Current