FDA.reportPublic FDA data

Mucinex D

Product NDC
63824-057
11-digit product format
638240057
Labeler code
63824
Product ID
63824-057_30dff058-07d6-63b5-e063-6294a90ad81f
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
600; 60 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

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
ndc (product): 63824-057
Mucinex D Maximum StrengthGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEReckitt Benckiser LLCd9264518-2f2c-498f-b733-6f3397336a012026-04-21WarningsExact identifier
application applno (NDA): 021585
application number: NDA021585
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN600 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE60 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
1305603Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d5f046c0-66b9-4cdc-9a1e-8e2cb5ece84fAvailable 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
63824-057-18Mucinex D1 in 1 CARTONTABLET, EXTENDED RELEASE111
63824-057-18Mucinex D18 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1811
63824-057-36Mucinex D4 in 1 CARTONTABLET, EXTENDED RELEASE411
63824-057-36Mucinex D9 in 1 BLISTER PACKTABLET, EXTENDED RELEASE911

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-057-18EA - Each63824-0579f595d60-5dc2-4bdd-9cd6-2fa7809a206312012-07-24
63824-057-36EA - Each63824-0571429e946-65a4-4011-8ae9-3c4ba733909d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GuaifenesinACTIVE INGREDIENT495W7451VQMUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]4
Pseudoephedrine HydrochlorideACTIVE INGREDIENT6V9V2RYJ8NMUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]4
GuaifenesinACTIVE MOIETY495W7451VQMUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]4
PseudoephedrineACTIVE MOIETY7CUC9DDI9FMUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]4
aluminum oxideINACTIVE INGREDIENTLMI26O6933MUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]4
carbomer homopolymer type B (allyl pentaerythritol crosslinked)INACTIVE INGREDIENTHHT01ZNK31MUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]4
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]4
FD&C yellow NO. 6INACTIVE INGREDIENTH77VEI93A8MUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]4
hypromellosesINACTIVE INGREDIENT3NXW29V3WOMUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]4
magnesium stearateINACTIVE INGREDIENT70097M6I30MUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]4
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS INC.]1
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NMUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NMUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS INC.]1
GUAIFENESINACTIVE MOIETY495W7451VQMUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
GuaifenesinACTIVE MOIETY495W7451VQMUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS INC.]1
PseudoephedrineACTIVE MOIETY7CUC9DDI9FMUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS INC.]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FMUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CARBOMER 934INACTIVE INGREDIENTZ135WT9208MUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOMUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-057MUCINEX D (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RB HEALTH (US) LLC]10Current NDC, Legacy NDC, 4 package rows20250323_d5f046c0-66b9-4cdc-9a1e-8e2cb5ece84f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305603guaiFENesin 600 MG / pseudoephedrine HCl 60 MG 12HR Extended Release Oral TabletPSN7f9cc03f-7cc9-4e3b-9ba9-a8d0103b98c913
1305603guaiFENesin 600 MG / pseudoephedrine HCl 60 MG 12HR Extended Release Oral TabletPSNd47cdbbc-34ae-4177-a222-225e1d7efbed13
130560312 HR guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG Extended Release Oral TabletSCD7f9cc03f-7cc9-4e3b-9ba9-a8d0103b98c913
130560312 HR guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG Extended Release Oral TabletSCDd47cdbbc-34ae-4177-a222-225e1d7efbed13
1305603guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG 12 HR Extended Release Oral TabletSY7f9cc03f-7cc9-4e3b-9ba9-a8d0103b98c913
1305603guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG 12 HR Extended Release Oral TabletSYd47cdbbc-34ae-4177-a222-225e1d7efbed13
1305603guaiFENesin 600 MG / pseudoephedrine HCl 60 MG 12HR Extended Release Oral TabletPSNd5f046c0-66b9-4cdc-9a1e-8e2cb5ece84f11
130560312 HR guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG Extended Release Oral TabletSCDd5f046c0-66b9-4cdc-9a1e-8e2cb5ece84f11
1305603guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG 12 HR Extended Release Oral TabletSYd5f046c0-66b9-4cdc-9a1e-8e2cb5ece84f11
1305603guaiFENesin 600 MG / pseudoephedrine HCl 60 MG 12HR Extended Release Oral TabletPSN9ae3a598-a423-4007-9ca6-95c687cb56d51
130560312 HR guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG Extended Release Oral TabletSCD9ae3a598-a423-4007-9ca6-95c687cb56d51
1305603guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG 12 HR Extended Release Oral TabletSY9ae3a598-a423-4007-9ca6-95c687cb56d51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-057-18638240057181 BLISTER PACK in 1 CARTON (63824-057-18) / 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2012-06-260000-00-00NoNoCurrent
63824-057-36638240057364 BLISTER PACK in 1 CARTON (63824-057-36) / 9 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2012-06-260000-00-00NoNoCurrent