Application 021282

Type: NDA
Sponsor: RB HLTH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MUCINEX	GUAIFENESIN	TABLET, EXTENDED RELEASE;ORAL	600MG	Yes	No
002	MUCINEX	GUAIFENESIN	TABLET, EXTENDED RELEASE;ORAL	1.2GM	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N021282-001	MUCINEX	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2002-07-12
N021282-002	MUCINEX	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2002-12-18

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`a50c72e98297…`

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	N021282-001	6372252	2020-04-28	U-489			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021282-001	6955821	2020-04-28	U-489	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021282-001	7838032	2020-04-28		Drug product	2010-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021282-002	6372252	2020-04-28	U-489			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021282-002	6955821	2020-04-28	U-489	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021282-002	7838032	2020-04-28		Drug product		`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021282-001	6372252	2020-04-28	U-489			`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021282-001	6955821	2020-04-28	U-489	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021282-001	7838032	2020-04-28		Drug product	2010-12-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021282-002	6372252	2020-04-28	U-489			`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021282-002	6955821	2020-04-28	U-489	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021282-002	7838032	2020-04-28		Drug product		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021282-001	6372252	2020-04-28	U-489			`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021282-001	6955821	2020-04-28	U-489	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021282-001	7838032	2020-04-28		Drug product	2010-12-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021282-002	6372252	2020-04-28	U-489			`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021282-002	6955821	2020-04-28	U-489	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021282-002	7838032	2020-04-28		Drug product		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021282-001	6372252	2020-04-28	U-489			`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021282-001	6955821	2020-04-28	U-489	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021282-001	7838032	2020-04-28		Drug product	2010-12-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021282-002	6372252	2020-04-28	U-489			`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021282-002	6955821	2020-04-28	U-489	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021282-002	7838032	2020-04-28		Drug product		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021282-001	6372252	2020-04-28	U-489			`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021282-001	6955821	2020-04-28	U-489	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021282-001	7838032	2020-04-28		Drug product	2010-12-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021282-002	6372252	2020-04-28	U-489			`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021282-002	6955821	2020-04-28	U-489	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021282-002	7838032	2020-04-28		Drug product		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021282-001	6372252	2020-04-28	U-489			`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021282-001	6955821	2020-04-28	U-489	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021282-001	7838032	2020-04-28		Drug product	2010-12-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021282-002	6372252	2020-04-28	U-489			`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021282-002	6955821	2020-04-28	U-489	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021282-002	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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex	GUAIFENESIN	Bryant Ranch Prepack	a898b584-e17e-45c4-8a28-9f686b95dca0	2026-06-29	Warnings	Exact identifier application applno (NDA): 021282 application number: NDA021282 ndc (product): 63629-7115
Mucinex	GUAIFENESIN	Bryant Ranch Prepack	a8c67e0a-1f2c-4e96-91fe-0d90546d8b1b	2026-06-29	Warnings	Exact identifier application applno (NDA): 021282 application number: NDA021282 ndc (product): 63629-7886
Mucinex Maximum Strength	GUAIFENESIN	Reckitt Benckiser LLC	47f5323c-ee3a-400d-b133-31d9c286fafd	2026-05-27	Warnings	Exact identifier application applno (NDA): 021282 application number: NDA021282 ndc (product): 63824-023
Mucinex	GUAIFENESIN	Reckitt Benckiser LLC	dd379cdd-90ab-42e0-ad89-f50d3220f611	2026-05-27	Warnings	Exact identifier application applno (NDA): 021282 application number: NDA021282 ndc (product): 63824-008
Mucinex	GUAIFENESIN	Cardinal Health 107, LLC	8b0d6d01-f1dd-41b0-a71e-46668bc9cde6	2026-05-12	Warnings	Exact identifier application applno (NDA): 021282 application number: NDA021282 ndc (product): 55154-4680
Mucinex	GUAIFENESIN	ATLANTIC BIOLOGICAS CORP.	40c67cca-f202-4652-9507-2442d26cfd67	2025-12-04	Warnings	Exact identifier application applno (NDA): 021282 application number: NDA021282 ndc (product): 17856-0008
Mucinex Maximum Strength	GUAIFENESIN	A-S Medication Solutions	7e09314c-3421-4053-a2ac-b67bf5610f83	2025-06-09	Warnings	Exact identifier application applno (NDA): 021282 application number: NDA021282 ndc (product): 50090-2301
Mucinex	GUAIFENESIN	American Health Packaging	0129f47d-abc2-414c-b4e1-1064c5d6a623	2024-07-25	Warnings	Exact identifier application applno (NDA): 021282 application number: NDA021282 ndc (product): 68084-572
MUCINEX	GUAIFENESIN	A-S Medication Solutions	69c83a02-377f-4c6c-96f6-557b3a3d8ca1	2024-05-29	Warnings	Exact identifier application applno (NDA): 021282 application number: NDA021282
Mucinex	GUAIFENESIN	A-S Medication Solutions	37a1c123-d623-40d0-a7fb-d4f7d126b340	2024-01-05	Warnings	Exact identifier application applno (NDA): 021282 application number: NDA021282 ndc (product): 50090-0818
Mucinex	GUAIFENESIN	A-S Medication Solutions	92a70574-c373-4261-b20d-8ea8ef677bcf	2023-12-09	Warnings	Exact identifier application applno (NDA): 021282 application number: NDA021282 ndc (product): 50090-1340
MUCINEX	GUAIFENESIN	A-S Medication Solutions	08ea92cc-4a0f-44c9-9edf-71f67e014431	2023-10-23	Warnings	Exact identifier application applno (NDA): 021282 application number: NDA021282 ndc (product): 50090-2380
Mucinex	GUAIFENESIN	Proficient Rx LP	f3ade814-2759-4ad0-a196-210e84d8cde9	2021-01-01	Warnings	Exact identifier application applno (NDA): 021282 application number: NDA021282 ndc (product): 63187-954
Mucinex	GUAIFENESIN	Aphena Pharma Solutions - Tennessee, LLC	1c84bf00-ebaa-4e69-a2c6-716631d209d9	2017-12-18	Warnings	Exact identifier application applno (NDA): 021282 application number: NDA021282 ndc (product): 67544-149

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 83 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0071	Mucus	Guaifenesin	walgreens	NDA	Current
0363-0074	Mucus	Guaifenesin	walgreens	NDA	Current
17856-0008	Mucinex	Guaifenesin	Atlantic Biologicals Corps	NDA	Current
17856-0008	Mucinex	Guaifenesin	Atlantic Biologicals Corps	NDA	Current
17856-0008	Mucinex	Guaifenesin	Atlantic Biologicals Corps	NDA	Current
17856-0008	Mucinex	Guaifenesin	Atlantic Biologicals Corps	NDA	Current
21695-870	Mucinex	Guaifenesin	Rebel Distributors Corp	NDA	Current
30142-701	Mucus	Guaifenesin	KROGER COMPANY	NDA	Current
30142-701	Mucus	Guaifenesin	KROGER COMPANY	NDA	Current
30142-701	Mucus	Guaifenesin	KROGER COMPANY	NDA	Current
30142-703	Guaifenesin	Guaifenesin	KROGER COMPANY	NDA	Current
30142-703	Guaifenesin	Guaifenesin	KROGER COMPANY	NDA	Current
30142-703	Guaifenesin	Guaifenesin	KROGER COMPANY	NDA	Current
46122-416	Mucus	Guaifenesin	AMERISOURCEBERGEN DRUG CORPORATION	NDA	Current
46122-416	Mucus	Guaifenesin	AMERISOURCEBERGEN DRUG CORPORATION	NDA	Current
46122-416	Mucus	Guaifenesin	AMERISOURCEBERGEN DRUG CORPORATION	NDA	Current
46122-417	Mucus	Guaifenesin	AMERISOURCEBERGEN DRUG CORPORATION	NDA	Current
49035-070	Mucus	Guaifenesin	WALMART STORES, INC.	NDA	Current
49035-070	Mucus	Guaifenesin	WALMART STORES, INC.	NDA	Current
49035-074	Guaifenesin	Guaifenesin	WALMART STORES, INC.	NDA	Current
49035-074	Guaifenesin	Guaifenesin	WALMART STORES, INC.	NDA	Current
50090-0818	Mucinex	Guaifenesin	A-S Medication Solutions	NDA	Current
50090-0818	Mucinex	Guaifenesin	A-S Medication Solutions	NDA	Current
50090-1340	Mucinex	Guaifenesin	A-S Medication Solutions	NDA	Current
50090-1340	Mucinex	Guaifenesin	A-S Medication Solutions	NDA	Current
50090-1340	Mucinex	Guaifenesin	A-S Medication Solutions	NDA	Current
50090-2301	Mucinex	Guaifenesin	A-S Medication Solutions	NDA	Current
50090-2301	Mucinex	Guaifenesin	A-S Medication Solutions	NDA	Current
50090-2301	Mucinex	Guaifenesin	A-S Medication Solutions	NDA	Current
50090-2301	Mucinex	Guaifenesin	A-S Medication Solutions	NDA	Current
50090-2380	Mucinex	Guaifenesin	A-S Medication Solutions	NDA	Current
50090-2380	Mucinex	Guaifenesin	A-S Medication Solutions	NDA	Current
51316-070	GUAIFENESIN	Guaifenesin	CVS PHARMACY, INC	NDA	Current
51660-070	GUAIFENESIN	Guaifenesin	OHM LABORATORIES INC	NDA	Current
51660-070	GUAIFENESIN	Guaifenesin	OHM LABORATORIES INC	NDA	Current
51660-072	Guaifenesin	Guaifenesin	OHM LABORATORIES INC	NDA	Current
53808-0871	Mucinex	Guaifenesin	State of Florida DOH Central Pharmacy	NDA	Current
55045-3143	MUCINEX	GUAIFENESIN	Dispensing Solutions, Inc.	NDA	Current
55154-4680	Mucinex	Guaifenesin	Cardinal Health 107, LLC	NDA	Current
55154-4680	Mucinex	Guaifenesin	Cardinal Health	NDA	Current
55289-087	Mucinex	Guaifenesin	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-087	Mucinex	Guaifenesin	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-087	Mucinex	Guaifenesin	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55700-489	Mucinex	Guaifenesin	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
61919-651	MUCINEX	MUCINEX	DIRECT RX	NDA	Current
61919-651	MUCINEX	MUCINEX	DIRECT RX	NDA	Current
62011-0347	Mucus	Guaifenesin	MCKESSON (HEALTH MART)	NDA	Current
63187-954	Mucinex	Guaifenesin	Proficient Rx LP	NDA	Current
63187-954	Mucinex	Guaifenesin	Proficient Rx LP	NDA	Current
63187-954	Mucinex	Guaifenesin	Proficient Rx LP	NDA	Current
63629-7115	Mucinex	Guaifenesin	Bryant Ranch Prepack	NDA	Current
63629-7115	Mucinex	Guaifenesin	Bryant Ranch Prepack	NDA	Current
63629-7115	Mucinex	Guaifenesin	Bryant Ranch Prepack	NDA	Current
63629-7115	Mucinex	Guaifenesin	Bryant Ranch Prepack	NDA	Current
63629-7886	Mucinex	Guaifenesin	Bryant Ranch Prepack	NDA	Current
63629-7886	Mucinex	Guaifenesin	Bryant Ranch Prepack	NDA	Current
63629-7886	Mucinex	Guaifenesin	Bryant Ranch Prepack	NDA	Current
63629-7886	Mucinex	Guaifenesin	Bryant Ranch Prepack	NDA	Current
63824-008	Mucinex	Guaifenesin	RB Health (US) LLC	NDA	Current
63824-008	Mucinex	Guaifenesin	RB Health (US) LLC	NDA	Current
63824-008	Mucinex	Guaifenesin	RB Health (US) LLC	NDA	Current
63824-008	Mucinex	Guaifenesin	RB Health (US) LLC	NDA	Current
63824-023	Mucinex	Guaifenesin	RB Health (US) LLC	NDA	Current
63824-023	Mucinex	Guaifenesin	RB Health (US) LLC	NDA	Current
63824-023	Mucinex	Guaifenesin	Reckitt Benckiser LLC	NDA	Current
63824-023	Mucinex	Guaifenesin	RB Health (US) LLC	NDA	Current
63868-389	Mucus	Guaifenesin	CHAIN DRUG MARKETING ASSOCIATION INC	NDA	Current
63868-390	Guaifenesin	Guaifenesin	CHAIN DRUG MARKETING ASSOCIATION INC	NDA	Current
67296-0569	Mucinex	Guaifenesin	RedPharm Drug, Inc.	NDA	Current
67544-149	Mucinex	Guaifenesin	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
68084-572	Mucinex	Guaifenesin	American Health Packaging	NDA	Current
68084-572	Mucinex	Guaifenesin	American Health Packaging	NDA	Current
68084-572	Mucinex	Guaifenesin	American Health Packaging	NDA	Current
68196-072	Guaifenesin	Guaifenesin	SAM'S WEST INC	NDA	Current
69842-016	Guaifenesin	Guaifenesin	CVS PHARMACY	NDA	Current
70518-0228	Mucinex	Guaifenesin	REMEDYREPACK INC.	NDA	Current
70518-0228	Mucinex	Guaifenesin	REMEDYREPACK INC.	NDA	Current
70518-0228	Mucinex	Guaifenesin	REMEDYREPACK INC.	NDA	Current
70518-0228	Mucinex	Guaifenesin	REMEDYREPACK INC.	NDA	Current
70518-0228	Mucinex	Guaifenesin	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79531	SUPPL	2024-09-03
79526	SUPPL	2024-09-03
68307	SUPPL	2021-08-06
66337	SUPPL	2021-02-23
66331	SUPPL	2021-02-23
64276	SUPPL	2020-08-13
60157	SUPPL	2019-09-30
60156	SUPPL	2019-09-30
60155	SUPPL	2019-09-30
60154	SUPPL	2019-09-30
60153	SUPPL	2019-09-30
54607	SUPPL	2018-06-19
48920	SUPPL	2017-07-06
48917	SUPPL	2017-07-06
27358	SUPPL	2014-03-07
4887	SUPPL	2014-03-07
4886	SUPPL	2009-04-07
27357	SUPPL	2008-08-22
36561	SUPPL	2007-09-07
27356	SUPPL	2007-09-07
27355	SUPPL	2006-11-22
4885	SUPPL	2006-09-18
4884	SUPPL	2002-12-18
21572	ORIG	2002-11-25
36560	ORIG	2002-07-12
27354	ORIG	2002-07-12