Mucinex DM

Product NDC
50090-2299
11-digit product format
500902299
Labeler code
50090
Product ID
50090-2299_a16e3992-5ac3-4040-960f-f7caa92d2388
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan Hydrobromide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA021620
Marketing category
NDA
Marketing start
2012-06-26
Marketing end
0000-00-00
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
600 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-2299DDiscontinued by firm2026-08-17
excluded packagepackage50090-229950090-2299-0DDiscontinued by firm2026-08-17

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-2299-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-2299-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-2299-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-2299-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-2299-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-2299-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-2299-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-2299-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-2299-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-2299-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-2299-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-2299-0557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021620-001MUCINEX DMDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29
N021620-002MUCINEX DMDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29bb7c543d1eb4…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021620-00163722522020-04-28Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021620-00169558212020-04-28U-685Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021620-00178380322020-04-28Drug product2010-12-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021620-00263722522020-04-28Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021620-00269558212020-04-28U-685Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021620-00278380322020-04-28Drug product74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021620-00163722522020-04-28Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021620-00169558212020-04-28U-685Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021620-00178380322020-04-28Drug product2010-12-218869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021620-00263722522020-04-28Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021620-00269558212020-04-28U-685Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021620-00278380322020-04-28Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021620-00163722522020-04-28Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021620-00169558212020-04-28U-685Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021620-00178380322020-04-28Drug product2010-12-21c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021620-00263722522020-04-28Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021620-00269558212020-04-28U-685Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021620-00278380322020-04-28Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021620-00163722522020-04-28Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021620-00169558212020-04-28U-685Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021620-00178380322020-04-28Drug product2010-12-213f01610625f2…
2019-12-14 00:12 UTC2019-12N021620-00263722522020-04-28Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021620-00269558212020-04-28U-685Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021620-00278380322020-04-28Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021620-00163722522020-04-28Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021620-00169558212020-04-28U-685Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021620-00178380322020-04-28Drug product2010-12-21b00525d2431f…
2019-09-15 20:21 UTC2019-09N021620-00263722522020-04-28Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021620-00269558212020-04-28U-685Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021620-00278380322020-04-28Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021620-00163722522020-04-28Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021620-00169558212020-04-28U-685Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021620-00178380322020-04-28Drug product2010-12-21ea99ee380514…
2019-07-19 19:46 UTC2019-07N021620-00263722522020-04-28Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021620-00269558212020-04-28U-685Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021620-00278380322020-04-28Drug productea99ee380514…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC70987d06-d206-445f-bd0d-5e1345b8465c2026-06-15WarningsExact identifier
application applno (NDA): 021620
application number: NDA021620
Mucinex DM Maximum StrengthGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC588eddc1-fa30-41cc-8ed9-c01319ea21c62026-05-27WarningsExact identifier
application applno (NDA): 021620
application number: NDA021620
Mucinex DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutionsc04e67da-51f6-4ce3-9852-419d7b3a37422026-05-22WarningsExact identifier
application applno (NDA): 021620
application number: NDA021620
Mucinex DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDESportpharm LLC8f4af6dd-6df4-49a7-98cf-6551369237342026-02-26WarningsExact identifier
application applno (NDA): 021620
application number: NDA021620
Mucinex DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDESelect Consumer Group3c9c8fb0-8a00-4b0f-e063-6394a90af6322025-12-28WarningsExact identifier
application applno (NDA): 021620
application number: NDA021620
MUCINEX DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutionsfcaf1df9-b396-44f2-94ce-e46e80aba66c2025-10-01WarningsExact identifier
application applno (NDA): 021620
application number: NDA021620
Mucinex DM, TRAVEL BASIXGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDELil' Drug Store Products, Inc.c274b05c-8f05-4980-9a93-77affb322e572023-10-10WarningsExact identifier
application applno (NDA): 021620
application number: NDA021620
Mucinex DM Maximum StrengthGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutions104b29ed-a377-4436-8e24-413c63579f2e2023-07-27WarningsExact identifier
application applno (NDA): 021620
application number: NDA021620
Mucinex DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINNavajo Manufacturing Company Inc.4226f394-f85e-45b1-8d5f-7cffb7dd492f2023-03-16WarningsExact identifier
application applno (NDA): 021620
application number: NDA021620