MUCINEX

Product NDC: 55045-3143
11-digit product format: 550453143
Labeler code: 55045
Product ID: 55045-3143_20baf571-544d-4945-b3dc-b905a54ec7bd
Type: HUMAN OTC DRUG
Nonproprietary name: GUAIFENESIN
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Dispensing Solutions, Inc.
Application: NDA021282
Marketing category: NDA
Marketing start: 2010-05-12
Marketing end: 0000-00-00
Substance: GUAIFENESIN
Active strength: 600 mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
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	55045-3143		I	Inactivated by FDA		2026-08-11
excluded package	package	55045-3143	55045-3143-2	I	Inactivated by FDA		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 · 44 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	55045-3143-2	`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	55045-3143-2	`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	55045-3143-2	`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	55045-3143-2	`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	55045-3143-2	`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	55045-3143-2	`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	55045-3143-2	`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	55045-3143-2	`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	55045-3143-2	`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	55045-3143-2	`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	55045-3143-2	`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	55045-3143-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55045-3143-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55045-3143-2	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55045-3143-2	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55045-3143-2	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55045-3143-2	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55045-3143-2	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	55045-3143-2	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	55045-3143-2	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	55045-3143-2	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	55045-3143-2	`110d247fa046…`	`a55b01930146…`

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
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 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	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021282-001	MUCINEX	600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021282-002	MUCINEX	1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-12-18	`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	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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55045-3143-2	2019-10-29	C162847	48780-1	960f7f55-ccb0-8e05-e053-dbdaa90a074a	Mucinex ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55045-3143-2	MUCINEX	20 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	20		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55045-3143-2	EA - Each	55045-3143	d0b4d890-44ce-42bc-931d-673a9798a6ef	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]	1
CARBOMER HOMOPOLYMER TYPE B	INACTIVE INGREDIENT	HHT01ZNK31	MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55045-3143	MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]	1	Legacy NDC, 1 package rows	20110630_6c53cc58-aaab-49f5-8d61-7ce2681bc6a8.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 · 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
Mucinex	GUAIFENESIN	Bryant Ranch Prepack	a8c67e0a-1f2c-4e96-91fe-0d90546d8b1b	2026-06-29	Warnings	Exact identifier application applno (NDA): 021282 application number: NDA021282
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
Mucinex	GUAIFENESIN	Reckitt Benckiser LLC	dd379cdd-90ab-42e0-ad89-f50d3220f611	2026-05-27	Warnings	Exact identifier application applno (NDA): 021282 application number: NDA021282
Mucinex	GUAIFENESIN	Cardinal Health 107, LLC	8b0d6d01-f1dd-41b0-a71e-46668bc9cde6	2026-05-12	Warnings	Exact identifier application applno (NDA): 021282 application number: NDA021282
Mucinex	GUAIFENESIN	ATLANTIC BIOLOGICAS CORP.	40c67cca-f202-4652-9507-2442d26cfd67	2025-12-04	Warnings	Exact identifier application applno (NDA): 021282 application number: NDA021282
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
Mucinex	GUAIFENESIN	American Health Packaging	0129f47d-abc2-414c-b4e1-1064c5d6a623	2024-07-25	Warnings	Exact identifier application applno (NDA): 021282 application number: NDA021282
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
Mucinex	GUAIFENESIN	A-S Medication Solutions	92a70574-c373-4261-b20d-8ea8ef677bcf	2023-12-09	Warnings	Exact identifier application applno (NDA): 021282 application number: NDA021282
MUCINEX	GUAIFENESIN	A-S Medication Solutions	08ea92cc-4a0f-44c9-9edf-71f67e014431	2023-10-23	Warnings	Exact identifier application applno (NDA): 021282 application number: NDA021282
Mucinex	GUAIFENESIN	Proficient Rx LP	f3ade814-2759-4ad0-a196-210e84d8cde9	2021-01-01	Warnings	Exact identifier application applno (NDA): 021282 application number: NDA021282
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

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	6c53cc58-aaab-49f5-8d61-7ce2681bc6a8	1
891301	Mucinex Expectorant 600 MG 12HR Extended Release Oral Tablet	PSN	6c53cc58-aaab-49f5-8d61-7ce2681bc6a8	1
891301	12 HR guaifenesin 600 MG Extended Release Oral Tablet [Mucinex]	SBD	6c53cc58-aaab-49f5-8d61-7ce2681bc6a8	1
636522	12 HR guaifenesin 600 MG Extended Release Oral Tablet	SCD	6c53cc58-aaab-49f5-8d61-7ce2681bc6a8	1
636522	guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	6c53cc58-aaab-49f5-8d61-7ce2681bc6a8	1
891301	Mucinex 600 MG 12 HR Extended Release Oral Tablet	SY	6c53cc58-aaab-49f5-8d61-7ce2681bc6a8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
55045-3143-2	55045314302	20 in 1 BOTTLE, PLASTIC	Historical