Guaifenesin and Pseudoephedrine Hydrochloride

Product NDC: 0363-0077
11-digit product format: 003630077
Labeler code: 0363
Product ID: 0363-0077_23bd928b-a15a-4da4-80c3-c599113f8376
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin and Pseudoephedrine Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: WALGREEN COMPANY
Application: NDA021585
Marketing category: NDA
Marketing start: 2017-08-01
Substance: GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 600; 60 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
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
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Guaifenesin and Pseudoephedrine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	600 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
495W7451VQ	Internal UNII lookup
6V9V2RYJ8N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1305603	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
310d14be-e7ea-44b8-8b04-cffa39440d50	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
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
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-0077-18	Guaifenesin and Pseudoephedrine Hydrochloride	18 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	18	2
0363-0077-18	Guaifenesin and Pseudoephedrine Hydrochloride	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	2
0363-0077-36	Guaifenesin and Pseudoephedrine Hydrochloride	2 in 1 CARTON	TABLET, EXTENDED RELEASE	2	2
0363-0077-36	Guaifenesin and Pseudoephedrine Hydrochloride	18 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	18	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0077	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [WALGREEN COMPANY]	2	Current NDC, Legacy NDC, 4 package rows	20181102_310d14be-e7ea-44b8-8b04-cffa39440d50.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 · 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 ndc (product): 0363-0077

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1305603	guaiFENesin 600 MG / pseudoephedrine HCl 60 MG 12HR Extended Release Oral Tablet	PSN	310d14be-e7ea-44b8-8b04-cffa39440d50	2
1305603	12 HR guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG Extended Release Oral Tablet	SCD	310d14be-e7ea-44b8-8b04-cffa39440d50	2
1305603	guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG 12 HR Extended Release Oral Tablet	SY	310d14be-e7ea-44b8-8b04-cffa39440d50	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-0077-18	00363007718	1 BLISTER PACK in 1 CARTON (0363-0077-18) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	1 blister pack	2017-08-01	0000-00-00	No	No	Current
0363-0077-36	00363007736	2 BLISTER PACK in 1 CARTON (0363-0077-36) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2 blister pack	2017-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Guaifenesin and Pseudoephedrine Hydrochloride	WALGREEN COMPANY \| Ohm Laboratories Inc.	2018-10-27	HUMAN OTC DRUG LABEL	2