Maximum Strength Mucus Relief

Product NDC: 68196-033
11-digit product format: 681960033
Labeler code: 68196
Product ID: 68196-033_3c3db64c-3dad-c118-e063-6294a90adc1b
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: SAM'S WEST INC
Application: ANDA217780
Marketing category: ANDA
Marketing start: 2025-08-20
Substance: GUAIFENESIN
Active strength: 1200 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
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Maximum Strength Mucus Relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	1200 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
310621	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
39282544-e1e8-8270-e063-6394a90a23fe	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
68196-033-56	Maximum Strength Mucus Relief	14 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	14		2
68196-033-56	Maximum Strength Mucus Relief	4 in 1 CARTON	TABLET, EXTENDED RELEASE	4		2

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 · 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
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 ndc (product): 68196-033
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

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
310621	guaiFENesin 1200 MG 12HR Extended Release Oral Tablet	PSN	39282544-e1e8-8270-e063-6394a90a23fe	2
310621	12 HR guaifenesin 1200 MG Extended Release Oral Tablet	SCD	39282544-e1e8-8270-e063-6394a90a23fe	2
310621	guaifenesin 1200 MG 12 HR Extended Release Oral Tablet	SY	39282544-e1e8-8270-e063-6394a90a23fe	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68196-033-56	68196003356	4 BLISTER PACK in 1 CARTON (68196-033-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	4 blister pack	2025-08-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sams Club Maximum Strength Mucus Relief Guaifenesin Extended Release Tablets 1200 mg	SAM'S WEST INC \| TIME CAP LABORATORIES,INC \| MARKSANS PHARMA LIMITED	2025-08-13	HUMAN OTC DRUG LABEL	2