FDA.reportPublic FDA data

Mucinex DM

Product NDC
63824-056
Requested package NDC
63824-056-50
11-digit product format
638240056
Labeler code
63824
Product ID
63824-056_324ae895-9603-57d1-e063-6394a90aaf45
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan Hydrobromide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
RB Health (US) LLC
Application
NDA021620
Marketing category
NDA
Marketing start
2012-06-26
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
30; 600 mg/1; mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63824-05663824-056-50DDiscontinued by firm2026-07-31

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-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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29a50c72e98297…
2026-08-01 22:54:322026-06N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (package): 63824-056-50
ndc (product): 63824-056
ndc11 (package): 63824005650
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

Additional Listing Data#

Finished product
Yes
Brand name base
Mucinex DM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN30 mg/1
DEXTROMETHORPHAN HYDROBROMIDE600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1298324Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
70987d06-d206-445f-bd0d-5e1345b8465cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-056-01Mucinex DM20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE2018
63824-056-01Mucinex DM5 in 1 CARTONTABLET, EXTENDED RELEASE518
63824-056-11Mucinex DM2 in 1 CARTONTABLET, EXTENDED RELEASE218
63824-056-11Mucinex DM12 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1218
63824-056-32Mucinex DM1 in 1 CARTONTABLET, EXTENDED RELEASE118
63824-056-32Mucinex DM20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE2018
63824-056-34Mucinex DM2 in 1 CARTONTABLET, EXTENDED RELEASE218
63824-056-34Mucinex DM20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE2018
63824-056-36Mucinex DM1 in 1 CARTONTABLET, EXTENDED RELEASE118
63824-056-36Mucinex DM6 in 1 BLISTER PACKTABLET, EXTENDED RELEASE618
63824-056-50Mucinex DM500 in 1 BOTTLETABLET, EXTENDED RELEASE50018
63824-056-69Mucinex DM20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE2018
63824-056-69Mucinex DM3 in 1 CARTONTABLET, EXTENDED RELEASE318
63824-056-72Mucinex DM2 in 1 POUCHTABLET, EXTENDED RELEASE218
63824-056-73Mucinex DM2 in 1 POUCHTABLET, EXTENDED RELEASE218
63824-056-74Mucinex DM24 in 1 CARTONTABLET, EXTENDED RELEASE2418
63824-056-80Mucinex DM2 in 1 CARTONTABLET, EXTENDED RELEASE218
63824-056-80Mucinex DM20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE2018
63824-056-89Mucinex DM4 in 1 CARTONTABLET, EXTENDED RELEASE418
63824-056-89Mucinex DM17 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1718

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-056-11EA - Each63824-056655a18b2-6c33-406d-8991-df75dc62ce5012021-04-08
63824-056-32EA - Each63824-056618c9634-633e-4967-9062-e99d6d608aab12012-07-24
63824-056-34EA - Each63824-05680569af0-2f07-4c5f-afdd-03fa8c52725612012-07-24
63824-056-36EA - Each63824-0566e774f37-0653-4855-a554-aa950008a74e12015-08-04
63824-056-50EA - Each63824-056219793fd-10e1-4304-a49e-36b3fcd093cc12021-07-15
63824-056-69EA - Each63824-056dea4a8a7-ef9d-4fd9-878a-24860e0261d112012-07-24
63824-056-80EA - Each63824-056022c0ea0-bcea-44b4-8022-eba46b028ae212024-08-12
63824-056-89EA - Each63824-0561858b821-0392-4596-912a-f59857e7c3a812019-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
GuaifenesinACTIVE INGREDIENT495W7451VQMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
DextromethorphanACTIVE MOIETY7355X3ROTSMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
GuaifenesinACTIVE MOIETY495W7451VQMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
aluminum oxideINACTIVE INGREDIENTLMI26O6933MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)INACTIVE INGREDIENTHHT01ZNK31MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3GMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
hypromellosesINACTIVE INGREDIENT3NXW29V3WOMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
magnesium stearateINACTIVE INGREDIENT70097M6I30MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
GUAIFENESINACTIVE MOIETY495W7451VQMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CARBOMER 934INACTIVE INGREDIENTZ135WT9208MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-056MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RB HEALTH (US) LLC]17Current NDC, Legacy NDC, 20 package rows20250410_70987d06-d206-445f-bd0d-5e1345b8465c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN70987d06-d206-445f-bd0d-5e1345b8465c18
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD70987d06-d206-445f-bd0d-5e1345b8465c18
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY70987d06-d206-445f-bd0d-5e1345b8465c18
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSNfcaf1df9-b396-44f2-94ce-e46e80aba66c16
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCDfcaf1df9-b396-44f2-94ce-e46e80aba66c16
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSYfcaf1df9-b396-44f2-94ce-e46e80aba66c16
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSNc04e67da-51f6-4ce3-9852-419d7b3a374212
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCDc04e67da-51f6-4ce3-9852-419d7b3a374212
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSYc04e67da-51f6-4ce3-9852-419d7b3a374212
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN4226f394-f85e-45b1-8d5f-7cffb7dd492f4
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN02be2813-9584-4d7a-98c9-ad591ea246be4
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD02be2813-9584-4d7a-98c9-ad591ea246be4
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD4226f394-f85e-45b1-8d5f-7cffb7dd492f4
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY4226f394-f85e-45b1-8d5f-7cffb7dd492f4
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY02be2813-9584-4d7a-98c9-ad591ea246be4
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN3c9c8fb0-8a00-4b0f-e063-6394a90af6322
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD3c9c8fb0-8a00-4b0f-e063-6394a90af6322
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY3c9c8fb0-8a00-4b0f-e063-6394a90af6322
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN8f4af6dd-6df4-49a7-98cf-6551369237341
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSNc818e103-9578-469c-97c0-d3515b934c031
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN25936338-9474-4b53-bd74-ff8c92d151b51
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD8f4af6dd-6df4-49a7-98cf-6551369237341
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD25936338-9474-4b53-bd74-ff8c92d151b51
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCDc818e103-9578-469c-97c0-d3515b934c031
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY8f4af6dd-6df4-49a7-98cf-6551369237341
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSYc818e103-9578-469c-97c0-d3515b934c031
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY25936338-9474-4b53-bd74-ff8c92d151b51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63824-056-5063824005650500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63824-056-50) 2021-06-010000-00-00NoNoCurrent