Mucus Relief

Product NDC: 85828-723
11-digit product format: 858280723
Labeler code: 85828
Product ID: 85828-723_4cf63f34-143f-6575-e063-6294a90a0f80
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Grocery Outlet, Inc.
Application: ANDA217780
Marketing category: ANDA
Marketing start: 2026-03-13
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

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
A217780-001	GUAIFENESIN	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL			2023-08-21
A217780-002	GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL			2023-08-21

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.

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	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217780-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217780-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2023-08-21	`a50c72e98297…`

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 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucus Relief	GUAIFENESIN	CVS Pharmacy	2cfbb804-de2b-5b2f-e063-6394a90a0824	2026-04-28	Warnings	Exact identifier application applno (ANDA): 217780 application number: ANDA217780
Mucus Relief	GUAIFENESIN	Grocery Outlet, Inc.	4466623c-6387-e725-e063-6394a90ad95e	2026-03-14	Warnings	Exact identifier application applno (ANDA): 217780 application number: ANDA217780 ndc (product): 85828-723
Guaifenesin 1200 mg	GUAIFENESIN 1200 MG	MARKSANS PHARMA LIMITED	fedf43d0-d6d1-4f50-bbab-396701e45cb2	2025-10-17	Warnings	Exact identifier application applno (ANDA): 217780 application number: ANDA217780
Mucus Relief	GUAIFENESIN	BJWC (Berkley & Jensen / BJ's)	2f32e8f9-260c-fa36-e063-6294a90a953d	2025-08-19	Warnings	Exact identifier application applno (ANDA): 217780 application number: ANDA217780
Maximum Strength Mucus Relief	GUAIFENESIN	SAM'S WEST INC	39282544-e1e8-8270-e063-6394a90a23fe	2025-08-13	Warnings	Exact identifier application applno (ANDA): 217780 application number: ANDA217780
Mucus Relief ER	GUAIFENESIN	Rugby Laboratories	2e6901aa-16f6-9b73-e063-6294a90a4d72	2025-08-02	Warnings	Exact identifier application applno (ANDA): 217780 application number: ANDA217780
Mucus Relief	GUAIFENESIN	LEADER/ Cardinal Health 110, Inc.	3099ac87-e61f-2f56-e063-6294a90aa891	2025-04-16	Warnings	Exact identifier application applno (ANDA): 217780 application number: ANDA217780
Maximum Strength Mucus Relief	GUAIFENESIN	KROGER COMPANY	100ff8e2-88ed-0e8c-e063-6294a90a5716	2024-05-25	Warnings	Exact identifier application applno (ANDA): 217780 application number: ANDA217780
Mucus Relief	GUAIFENESIN	KROGER COMPANY	100f59fb-f9e7-5acb-e063-6394a90af450	2024-05-21	Warnings	Exact identifier application applno (ANDA): 217780 application number: ANDA217780
Guaifenesin Extended Release 600 mg	GUAIFENESIN	TIME CAP LABORATORIES, INC.	10c42869-7df0-3046-e063-6394a90aa679	2024-02-07	Warnings	Exact identifier application applno (ANDA): 217780 application number: ANDA217780

Additional Listing Data#

Finished product: Yes
Brand name base: 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
4466623c-6387-e725-e063-6394a90ad95e	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	Strength	SPL version
85828-723-02	Mucus Relief	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1		2
85828-723-02	Mucus Relief	20 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	20		2

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	4466623c-6387-e725-e063-6394a90ad95e	2
636522	12 HR guaifenesin 600 MG Extended Release Oral Tablet	SCD	4466623c-6387-e725-e063-6394a90ad95e	2
636522	guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	4466623c-6387-e725-e063-6394a90ad95e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85828-723-02	85828072302	1 BLISTER PACK in 1 CARTON (85828-723-02) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	1 blister pack	2026-03-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Grocery Outlet Guaifenesin Extended Release Tablets USP 600 mg	Grocery Outlet, Inc. \| TIME CAP LABORATORIES, INC. \| MARKSANS PHARMA LIMITED	2026-03-14	HUMAN OTC DRUG LABEL	2