Guaifenesin Extended-Release

Product NDC: 68094-048
11-digit product format: 680940048
Labeler code: 68094
Product ID: 68094-048_9147ee25-d849-468c-a83d-7b413539c487
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin
Dosage form: TABLET, MULTILAYER, EXTENDED RELEASE
Route: ORAL
Labeler: Precision Dose Inc.
Application: ANDA078912
Marketing category: ANDA
Marketing start: 2023-03-22
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
A078912-001	GUAIFENESIN	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL			2011-11-23
A078912-002	GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL			2020-11-05

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 2 · 77 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	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078912-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-11-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078912-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2011-11-23	`87673890dc5c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Guaifenesin Extended-Release
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
608b00c5-a2c7-4514-9b46-02954d6675d6	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
68094-048-59	Guaifenesin Extended-Release	10 in 1 BLISTER PACK	TABLET, MULTILAYER, EXTENDED REL	10		3
68094-048-61	Guaifenesin Extended-Release	10 in 1 CARTON	TABLET, MULTILAYER, EXTENDED REL	10		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68094-048-59	EA - Each	68094-048	d0f4fa0d-d413-4fe0-838f-1d7512c92957	1	2023-06-06
68094-048-61	EA - Each	68094-048	802f3665-498b-44d8-ac74-625a850278ae	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68094-048	GUAIFENESIN EXTENDED-RELEASE (GUAIFENESIN) TABLET, MULTILAYER, EXTENDED RELEASE [PRECISION DOSE INC.]	3	Current NDC, 2 package rows	20250529_608b00c5-a2c7-4514-9b46-02954d6675d6.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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
mucus relief	GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	51194399-6ded-4142-8880-9e810e628352	2026-07-13	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
equate mucus-er	GUAIFENESIN	WALMART INC.	a2cc6dec-388a-46bd-9cbc-1ffb6fd1aea3	2026-07-02	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
RUGBY MUCUS RELIEF ER	GUAIFENESIN	Rugby Laboratories	b82ba4cb-8e96-41cc-81c4-ab976410fa30	2026-06-15	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
mucus relief	GUAIFENESIN	Rite Aid Corporation	0c68d8f0-7e02-42b3-8150-2ed66a13e282	2026-06-03	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
equate mucus relief	GUAIFENESIN	WALMART INC.	154602ca-91c4-4030-ae77-9bf179cc95e8	2026-05-26	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
MUCUS RELIEF	GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	2caa7f8e-695c-441a-a968-fcc3f527d117	2026-05-13	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
good sense mucus er	GUAIFENESIN	Redpharm Drug	4fb57f87-f761-b52e-e063-6294a90ae4ee	2026-04-18	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
Leader Mucus Relief	GUAIFENESIN	Cardinal Health 110, LLC. dba Leader	ca735722-0baa-4c85-8311-17dbce915fc5	2026-04-08	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
mucus er	GUAIFENESIN	HyVee Inc	851f49b5-34a0-4c58-90fa-51e265c7f731	2026-03-26	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
MUCUS AND CHEST CONGESTION	GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	f341aa99-5339-4087-a98a-469231dfc6d0	2026-02-17	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
up and up mucus relief	GUAIFENESIN	Target Corporation	7c1598f1-1236-48d2-861b-de4715e3f3d2	2026-02-05	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
mucus er	GUAIFENESIN	HyVee Inc	74136552-55b2-4dee-9c66-3f84e9dc63d6	2026-02-03	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
MUCUS AND CHEST CONGESTION	GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	f505e0bd-8881-4e51-a2fc-4e649bac3bff	2026-01-14	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
UP AND UP MUCUS RELIEF	GUAIFENESIN	Target Corporation	059cff23-b6a5-40dc-ac4e-9bcb552e9764	2025-09-22	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
Good Sense Mucus ER	GUAIFENESIN	L. Perrigo Company	30860399-d9a3-409b-bfac-00597c74b175	2025-07-16	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
basic care mucus er max	GUAIFENESIN	Amazon.com Services LLC	3552346e-4650-44c1-9233-57251a029133	2025-07-02	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
Good Neighbor Pharmacy Mucus ER	GUAIFENESIN	Amerisource Bergen	5810b584-bbfa-4dd2-b237-71520a214c09	2025-06-17	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
mucus extended release	GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	9fcf96a7-bef4-4cc8-bd9e-c245ccbea17d	2025-06-17	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
Rugby Mucus Relief ER	GUAIFENESIN	Rugby Laboratories	1c579aea-c9c5-44d0-997b-f350f84ac6d0	2025-06-17	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912
DG health mucus er max	GUAIFENESIN	Dolgencorp Inc	4353d561-0e6d-4d36-b356-dd6506b5a3ee	2025-06-06	Warnings	Exact identifier application applno (ANDA): 078912 application number: ANDA078912

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	608b00c5-a2c7-4514-9b46-02954d6675d6	3
636522	12 HR guaifenesin 600 MG Extended Release Oral Tablet	SCD	608b00c5-a2c7-4514-9b46-02954d6675d6	3
636522	guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	608b00c5-a2c7-4514-9b46-02954d6675d6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68094-048-59	68094004859	10 in 1 BLISTER PACK					Historical
68094-048-61	68094004861	10 BLISTER PACK in 1 CARTON (68094-048-61) / 10 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK (68094-048-59)	10 blister pack	2023-03-22	No	No	Current