Guaifenesin and Dextromethorphan Hydrobromide

Product NDC
51660-073
Requested package NDC
51660-073-86
11-digit product format
516600073
Labeler code
51660
Product ID
51660-073_62d9d841-9307-45a7-89a7-cba5cded1462
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan Hydrobromide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
OHM LABORATORIES 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51660-07351660-073-86IInactivated by FDA2026-08-17

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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…

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51660-073-54Guaifenesin and Dextromethorphan Hydrobromide14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE143
51660-073-54Guaifenesin and Dextromethorphan Hydrobromide1 in 1 CARTONTABLET, EXTENDED RELEASE13
51660-073-86Guaifenesin and Dextromethorphan Hydrobromide2 in 1 CARTONTABLET, EXTENDED RELEASE23
51660-073-86Guaifenesin and Dextromethorphan Hydrobromide14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE143

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51660-073-54EA - Each51660-0736e964448-c4fb-436c-9650-fb58e3d2d81d12019-03-12
51660-073-86EA - Each51660-0737dc7f87e-a60b-42bb-8e2c-e4e1721a203712019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-073GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET, EXTENDED RELEASE [OHM LABORATORIES INC]3Legacy NDC, 4 package rows20181102_ed496cde-4355-45c4-80f0-84df06c32523.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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSNed496cde-4355-45c4-80f0-84df06c325233
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCDed496cde-4355-45c4-80f0-84df06c325233
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYed496cde-4355-45c4-80f0-84df06c325233

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51660-073-86516600073862 BLISTER PACK in 1 CARTON (51660-073-86) > 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2017-12-100000-00-00NoNoCurrent