FDA.reportPublic FDA data

Mucinex D

Product NDC
63824-041
Requested package NDC
63824-041-12
11-digit product format
638240041
Labeler code
63824
Product ID
63824-041_302b8792-38f6-a209-e063-6294a90af24f
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Pseudoephedrine Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
RB Health (US) LLC
Application
NDA021585
Marketing category
NDA
Marketing start
2012-06-26
Substance
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
1200; 120 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]
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 packagepackage63824-04163824-041-12DDiscontinued 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
N021585-001MUCINEX DGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-22
N021585-002MUCINEX DGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-22

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 22:54:322026-06N021585-001MUCINEX D600MG;60MGTABLET, EXTENDED RELEASE / ORALRLD2004-06-22a50c72e98297…
2026-08-01 22:54:322026-06N021585-002MUCINEX D1.2GM;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2004-06-22a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEReckitt Benckiser LLCd5f046c0-66b9-4cdc-9a1e-8e2cb5ece84f2026-05-27WarningsExact identifier
application applno (NDA): 021585
application number: NDA021585
Mucinex D Maximum StrengthGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEReckitt Benckiser LLCd9264518-2f2c-498f-b733-6f3397336a012026-04-21WarningsExact identifier
application applno (NDA): 021585
application number: NDA021585
ndc (package): 63824-041-12
ndc (product): 63824-041
ndc11 (package): 63824004112
Mucinex DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEA-S Medication Solutions7f9cc03f-7cc9-4e3b-9ba9-a8d0103b98c92025-06-23WarningsExact identifier
application applno (NDA): 021585
application number: NDA021585
MUCINEX DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEA-S Medication Solutionsd47cdbbc-34ae-4177-a222-225e1d7efbed2024-01-11WarningsExact identifier
application applno (NDA): 021585
application number: NDA021585
Guaifenesin and Pseudoephedrine HydrochlorideGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEWALGREEN COMPANY310d14be-e7ea-44b8-8b04-cffa39440d502018-10-27WarningsExact identifier
application applno (NDA): 021585
application number: NDA021585

Additional Listing Data#

Finished product
Yes
Brand name base
Mucinex D
Brand name suffix
Maximum Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN1200 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE120 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
6V9V2RYJ8NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1244675Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9264518-2f2c-498f-b733-6f3397336a01Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-041-12Mucinex DMaximum Strength1 in 1 CARTONTABLET, EXTENDED RELEASE112
63824-041-12Mucinex DMaximum Strength12 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1212
63824-041-24Mucinex DMaximum Strength12 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1212
63824-041-24Mucinex DMaximum Strength2 in 1 CARTONTABLET, EXTENDED RELEASE212
63824-041-36Mucinex DMaximum Strength3 in 1 CARTONTABLET, EXTENDED RELEASE312
63824-041-36Mucinex DMaximum Strength12 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1212
63824-041-71Mucinex DMaximum Strength1 in 1 POUCHTABLET, EXTENDED RELEASE112
63824-041-71Mucinex DMaximum Strength24 in 1 CARTONTABLET, EXTENDED RELEASE2412

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-041-24EA - Each63824-04161015d30-476d-485d-9f12-8b703c060b4b12012-07-24
63824-041-36EA - Each63824-04147d8722a-355a-4e8b-bc31-657a5615e30812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GuaifenesinACTIVE INGREDIENT495W7451VQMUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
Pseudoephedrine HydrochlorideACTIVE INGREDIENT6V9V2RYJ8NMUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
GuaifenesinACTIVE MOIETY495W7451VQMUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
PseudoephedrineACTIVE MOIETY7CUC9DDI9FMUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
aluminum oxideINACTIVE INGREDIENTLMI26O6933MUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
carbomer homopolymer type B (allyl pentaerythritol crosslinked)INACTIVE INGREDIENTHHT01ZNK31MUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
FD&C yellow NO. 6INACTIVE INGREDIENTH77VEI93A8MUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
hypromellosesINACTIVE INGREDIENT3NXW29V3WOMUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]6
magnesium stearateINACTIVE INGREDIENT70097M6I30MUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-041MUCINEX D MAXIMUM STRENGTH (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RB HEALTH (US) LLC]11Current NDC, Legacy NDC, 8 package rows20250315_d9264518-2f2c-498f-b733-6f3397336a01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1244675guaiFENesin 1200 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSNd9264518-2f2c-498f-b733-6f3397336a0112
124467512 HR guaifenesin 1200 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCDd9264518-2f2c-498f-b733-6f3397336a0112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-041-12638240041121 BLISTER PACK in 1 CARTON (63824-041-12) > 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2020-01-010000-00-00NoNoCurrent