Mucinex D

Product NDC: 70518-0523
11-digit product format: 705180523
Labeler code: 70518
Product ID: 70518-0523_eca852c1-37de-861d-e053-2a95a90a95e1
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin and Pseudoephedrine Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: NDA021585
Marketing category: NDA
Marketing start: 2017-05-11
Marketing end: 0000-00-00
Substance: GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 600 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]
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	70518-0523		D	Discontinued by firm		2026-08-11
excluded package	package	70518-0523	70518-0523-0	D	Discontinued by firm		2026-08-11

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 · 24 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-0523-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-0523-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-0523-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-0523-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-0523-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-0523-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-0523-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-0523-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-0523-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-0523-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-0523-0	`367a005e9d99…`	`383a685ebd0f…`
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	70518-0523-0	`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
N021585-001	MUCINEX D	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-06-22
N021585-002	MUCINEX D	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2004-06-22

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`782e0a99824c…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021585-001	6372252	2020-04-28		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021585-001	6955821	2020-04-28	U-686	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021585-001	7838032	2020-04-28		Drug product	2010-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021585-002	6372252	2020-04-28		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021585-002	6955821	2020-04-28	U-686	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021585-002	7838032	2020-04-28		Drug product		`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021585-001	6372252	2020-04-28		Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021585-001	6955821	2020-04-28	U-686	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021585-001	7838032	2020-04-28		Drug product	2010-12-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021585-002	6372252	2020-04-28		Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021585-002	6955821	2020-04-28	U-686	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021585-002	7838032	2020-04-28		Drug product		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021585-001	6372252	2020-04-28		Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021585-001	6955821	2020-04-28	U-686	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021585-001	7838032	2020-04-28		Drug product	2010-12-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021585-002	6372252	2020-04-28		Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021585-002	6955821	2020-04-28	U-686	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021585-002	7838032	2020-04-28		Drug product		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021585-001	6372252	2020-04-28		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021585-001	6955821	2020-04-28	U-686	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021585-001	7838032	2020-04-28		Drug product	2010-12-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021585-002	6372252	2020-04-28		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021585-002	6955821	2020-04-28	U-686	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021585-002	7838032	2020-04-28		Drug product		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021585-001	6372252	2020-04-28		Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021585-001	6955821	2020-04-28	U-686	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021585-001	7838032	2020-04-28		Drug product	2010-12-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021585-002	6372252	2020-04-28		Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021585-002	6955821	2020-04-28	U-686	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021585-002	7838032	2020-04-28		Drug product		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021585-001	6372252	2020-04-28		Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021585-001	6955821	2020-04-28	U-686	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021585-001	7838032	2020-04-28		Drug product	2010-12-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021585-002	6372252	2020-04-28		Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021585-002	6955821	2020-04-28	U-686	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021585-002	7838032	2020-04-28		Drug product		`ea99ee380514…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex D	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Reckitt Benckiser LLC	d5f046c0-66b9-4cdc-9a1e-8e2cb5ece84f	2026-05-27	Warnings	Exact identifier application applno (NDA): 021585 application number: NDA021585
Mucinex D Maximum Strength	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Reckitt Benckiser LLC	d9264518-2f2c-498f-b733-6f3397336a01	2026-04-21	Warnings	Exact identifier application applno (NDA): 021585 application number: NDA021585
Mucinex D	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	A-S Medication Solutions	7f9cc03f-7cc9-4e3b-9ba9-a8d0103b98c9	2025-06-23	Warnings	Exact identifier application applno (NDA): 021585 application number: NDA021585
MUCINEX D	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	A-S Medication Solutions	d47cdbbc-34ae-4177-a222-225e1d7efbed	2024-01-11	Warnings	Exact identifier application applno (NDA): 021585 application number: NDA021585
Guaifenesin and Pseudoephedrine Hydrochloride	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	WALGREEN COMPANY	310d14be-e7ea-44b8-8b04-cffa39440d50	2018-10-27	Warnings	Exact identifier application applno (NDA): 021585 application number: NDA021585

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-0523-0	70518052300	1 BLISTER PACK in 1 CARTON (70518-0523-0) > 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	1 blister pack	2017-05-11	0000-00-00	No	No	Current