FDA.reportPublic FDA data

Mucinex DM

Product NDC
63824-072
11-digit product format
638240072
Labeler code
63824
Product ID
63824-072_324b0a12-8964-731d-e063-6394a90a00a7
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
60; 1200 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 packagepackage63824-07263824-072-18DDiscontinued 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
Mucinex DM Maximum StrengthGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC588eddc1-fa30-41cc-8ed9-c01319ea21c62026-05-27WarningsExact identifier
application applno (NDA): 021620
application number: NDA021620
ndc (product): 63824-072
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
Brand name suffix
Maximum Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN60 mg/1
DEXTROMETHORPHAN HYDROBROMIDE1200 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
1099074Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
588eddc1-fa30-41cc-8ed9-c01319ea21c6Available 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
63824-072-02Mucinex DMMaximum Strength1 in 1 CARTONTABLET, EXTENDED RELEASE118
63824-072-02Mucinex DMMaximum Strength1 in 1 POUCHTABLET, EXTENDED RELEASE118
63824-072-07Mucinex DMMaximum Strength1 in 1 CARTONTABLET, EXTENDED RELEASE118
63824-072-07Mucinex DMMaximum Strength7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE718
63824-072-18Mucinex DMMaximum Strength2 in 1 CARTONTABLET, EXTENDED RELEASE218
63824-072-18Mucinex DMMaximum Strength9 in 1 BLISTER PACKTABLET, EXTENDED RELEASE918
63824-072-35Mucinex DMMaximum Strength1 in 1 CARTONTABLET, EXTENDED RELEASE118
63824-072-35Mucinex DMMaximum Strength14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1418
63824-072-36Mucinex DMMaximum Strength14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1418
63824-072-36Mucinex DMMaximum Strength2 in 1 CARTONTABLET, EXTENDED RELEASE218
63824-072-46Mucinex DMMaximum Strength3 in 1 CARTONTABLET, EXTENDED RELEASE318
63824-072-46Mucinex DMMaximum Strength14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1418
63824-072-48Mucinex DMMaximum Strength4 in 1 CARTONTABLET, EXTENDED RELEASE418
63824-072-48Mucinex DMMaximum Strength12 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1218
63824-072-56Mucinex DMMaximum Strength4 in 1 CARTONTABLET, EXTENDED RELEASE418
63824-072-56Mucinex DMMaximum Strength14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1418

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-072-07EA - Each63824-0721a92612a-1867-48de-b636-76856e8a4eff12015-08-04
63824-072-18EA - Each63824-07237cc9afa-3a15-4710-9860-34e75bb1126812021-05-05
63824-072-35EA - Each63824-072ece4c5f8-5fd4-446a-acd5-58bfee9cd56a12012-07-24
63824-072-36EA - Each63824-0729cc6f6f8-37c5-4a46-b3d1-cb9f284b194312012-07-24
63824-072-45EA - Each63824-07262ba5fca-2281-40b6-8e33-b5ff0e5489e412012-07-24
63824-072-46EA - Each63824-072ed63d0ad-77d3-4ecc-a20e-acb1f577dd7512012-07-24
63824-072-48EA - Each63824-0726d7befc8-f5c3-4f32-9d9f-8b9dfc191aab12012-07-24
63824-072-56EA - Each63824-0727cacc7e0-d118-471c-bba3-9e1bc8c67c3412021-08-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHMUCINEX DM MAXIMUM STRENGTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
GuaifenesinACTIVE INGREDIENT495W7451VQMUCINEX DM MAXIMUM STRENGTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
DextromethorphanACTIVE MOIETY7355X3ROTSMUCINEX DM MAXIMUM STRENGTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
GuaifenesinACTIVE MOIETY495W7451VQMUCINEX DM MAXIMUM STRENGTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
aluminum oxideINACTIVE INGREDIENTLMI26O6933MUCINEX DM MAXIMUM STRENGTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)INACTIVE INGREDIENTHHT01ZNK31MUCINEX DM MAXIMUM STRENGTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMUCINEX DM MAXIMUM STRENGTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3GMUCINEX DM MAXIMUM STRENGTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
hypromellosesINACTIVE INGREDIENT3NXW29V3WOMUCINEX DM MAXIMUM STRENGTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]8
magnesium stearateINACTIVE INGREDIENT70097M6I30MUCINEX DM MAXIMUM STRENGTH (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.]2
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
GUAIFENESINACTIVE MOIETY495W7451VQMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
CARBOMER 934INACTIVE INGREDIENTZ135WT9208MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOMUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-072MUCINEX DM MAXIMUM STRENGTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [RB HEALTH (US) LLC]17Current NDC, Legacy NDC, 16 package rows20250410_588eddc1-fa30-41cc-8ed9-c01319ea21c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN588eddc1-fa30-41cc-8ed9-c01319ea21c618
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD588eddc1-fa30-41cc-8ed9-c01319ea21c618
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY588eddc1-fa30-41cc-8ed9-c01319ea21c618
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN104b29ed-a377-4436-8e24-413c63579f2e4
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD104b29ed-a377-4436-8e24-413c63579f2e4
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY104b29ed-a377-4436-8e24-413c63579f2e4
1099074guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral TabletPSN60720afd-c08a-4cfa-989f-dbc4b13d4a102
109907412 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral TabletSCD60720afd-c08a-4cfa-989f-dbc4b13d4a102
1099074dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY60720afd-c08a-4cfa-989f-dbc4b13d4a102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-072-02638240072021 POUCH in 1 CARTON (63824-072-02) / 1 TABLET, EXTENDED RELEASE in 1 POUCH1 pouch2021-08-010000-00-00NoNoCurrent
63824-072-07638240072071 BLISTER PACK in 1 CARTON (63824-072-07) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2012-06-260000-00-00NoNoCurrent
63824-072-18638240072182 BLISTER PACK in 1 CARTON (63824-072-18) > 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2012-06-260000-00-00NoNoCurrent
63824-072-35638240072351 BLISTER PACK in 1 CARTON (63824-072-35) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2012-06-260000-00-00NoNoCurrent
63824-072-36638240072362 BLISTER PACK in 1 CARTON (63824-072-36) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2012-06-260000-00-00NoNoCurrent
63824-072-46638240072463 BLISTER PACK in 1 CARTON (63824-072-46) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK3 blister pack2012-06-260000-00-00NoNoCurrent
63824-072-48638240072484 BLISTER PACK in 1 CARTON (63824-072-48) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2012-06-260000-00-00NoNoCurrent
63824-072-56638240072564 BLISTER PACK in 1 CARTON (63824-072-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2021-07-010000-00-00NoNoCurrent