Guaifenesin and Dextromethorphan Hydrobromide

Product NDC: 63868-391
11-digit product format: 638680391
Labeler code: 63868
Product ID: 63868-391_0e0be98e-adad-4427-aac5-7d37736f0cdd
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin and Dextromethorphan Hydrobromide
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: CHAIN DRUG MARKETING ASSOCIATION INC
Application: NDA021620
Marketing category: NDA
Marketing start: 2017-12-10
Marketing end: 0000-00-00
Substance: GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 1200 mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
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	63868-391		I	Inactivated by FDA		2026-08-17
excluded package	package	63868-391	63868-391-14	I	Inactivated by FDA		2026-08-17

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 · 38 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	63868-391-14	`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	63868-391-14	`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	63868-391-14	`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	63868-391-14	`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	63868-391-14	`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	63868-391-14	`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	63868-391-14	`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	63868-391-14	`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	63868-391-14	`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	63868-391-14	`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	63868-391-14	`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	63868-391-14	`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	63868-391-14	`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	63868-391-14	`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	63868-391-14	`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	63868-391-14	`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	63868-391-14	`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	63868-391-14	`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	63868-391-14	`8dfbde2a14a4…`	`c9ff85d89658…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021620-001	MUCINEX DM	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2004-04-29
N021620-002	MUCINEX DM	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-04-29

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021620-001	MUCINEX DM	60MG;1.2GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-04-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021620-002	MUCINEX DM	30MG;600MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-04-29	`bb7c543d1eb4…`

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	N021620-001	6372252	2020-04-28		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021620-001	6955821	2020-04-28	U-685	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021620-001	7838032	2020-04-28		Drug product	2010-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021620-002	6372252	2020-04-28		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021620-002	6955821	2020-04-28	U-685	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021620-002	7838032	2020-04-28		Drug product		`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021620-001	6372252	2020-04-28		Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021620-001	6955821	2020-04-28	U-685	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021620-001	7838032	2020-04-28		Drug product	2010-12-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021620-002	6372252	2020-04-28		Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021620-002	6955821	2020-04-28	U-685	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021620-002	7838032	2020-04-28		Drug product		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021620-001	6372252	2020-04-28		Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021620-001	6955821	2020-04-28	U-685	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021620-001	7838032	2020-04-28		Drug product	2010-12-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021620-002	6372252	2020-04-28		Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021620-002	6955821	2020-04-28	U-685	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021620-002	7838032	2020-04-28		Drug product		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021620-001	6372252	2020-04-28		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021620-001	6955821	2020-04-28	U-685	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021620-001	7838032	2020-04-28		Drug product	2010-12-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021620-002	6372252	2020-04-28		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021620-002	6955821	2020-04-28	U-685	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021620-002	7838032	2020-04-28		Drug product		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021620-001	6372252	2020-04-28		Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021620-001	6955821	2020-04-28	U-685	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021620-001	7838032	2020-04-28		Drug product	2010-12-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021620-002	6372252	2020-04-28		Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021620-002	6955821	2020-04-28	U-685	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021620-002	7838032	2020-04-28		Drug product		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021620-001	6372252	2020-04-28		Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021620-001	6955821	2020-04-28	U-685	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021620-001	7838032	2020-04-28		Drug product	2010-12-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021620-002	6372252	2020-04-28		Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021620-002	6955821	2020-04-28	U-685	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021620-002	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
63868-391-14	2021-01-29	C162847	48780-1	ba0f9c33-4125-a910-e053-dadaa90a0b85	Guaifenesin 1200 mg & Dextromethorphan HBr 60 mg Extended-Release Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-391-14	Guaifenesin and Dextromethorphan Hydrobromide	2 in 1 CARTON	TABLET, EXTENDED RELEASE	2		2
63868-391-14	Guaifenesin and Dextromethorphan Hydrobromide	14 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	14		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-391	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET, EXTENDED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]	2	Legacy NDC, 2 package rows	20171210_bf76e2f5-f2d0-4998-8ca7-969100fda42c.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex DM	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	70987d06-d206-445f-bd0d-5e1345b8465c	2026-06-15	Warnings	Exact identifier application applno (NDA): 021620 application number: NDA021620
Mucinex DM Maximum Strength	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	588eddc1-fa30-41cc-8ed9-c01319ea21c6	2026-05-27	Warnings	Exact identifier application applno (NDA): 021620 application number: NDA021620
Mucinex DM	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	A-S Medication Solutions	c04e67da-51f6-4ce3-9852-419d7b3a3742	2026-05-22	Warnings	Exact identifier application applno (NDA): 021620 application number: NDA021620
Mucinex DM	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Sportpharm LLC	8f4af6dd-6df4-49a7-98cf-655136923734	2026-02-26	Warnings	Exact identifier application applno (NDA): 021620 application number: NDA021620
Mucinex DM	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Select Consumer Group	3c9c8fb0-8a00-4b0f-e063-6394a90af632	2025-12-28	Warnings	Exact identifier application applno (NDA): 021620 application number: NDA021620
MUCINEX DM	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	A-S Medication Solutions	fcaf1df9-b396-44f2-94ce-e46e80aba66c	2025-10-01	Warnings	Exact identifier application applno (NDA): 021620 application number: NDA021620
Mucinex DM, TRAVEL BASIX	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Lil' Drug Store Products, Inc.	c274b05c-8f05-4980-9a93-77affb322e57	2023-10-10	Warnings	Exact identifier application applno (NDA): 021620 application number: NDA021620
Mucinex DM Maximum Strength	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	A-S Medication Solutions	104b29ed-a377-4436-8e24-413c63579f2e	2023-07-27	Warnings	Exact identifier application applno (NDA): 021620 application number: NDA021620
Mucinex DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Navajo Manufacturing Company Inc.	4226f394-f85e-45b1-8d5f-7cffb7dd492f	2023-03-16	Warnings	Exact identifier application applno (NDA): 021620 application number: NDA021620

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1099074	guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral Tablet	PSN	bf76e2f5-f2d0-4998-8ca7-969100fda42c	2
1099074	12 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral Tablet	SCD	bf76e2f5-f2d0-4998-8ca7-969100fda42c	2
1099074	dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral Tablet	SY	bf76e2f5-f2d0-4998-8ca7-969100fda42c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
63868-391-14	63868039114	2 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Guaifenesin 1200 mg & Dextromethorphan HBr 60 mg Extended-Release Tablets	CHAIN DRUG MARKETING ASSOCIATION INC \| RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD	2017-10-16	HUMAN OTC DRUG LABEL	2