FDA.reportPublic FDA data

Mucinex

Product NDC
21695-870
11-digit product format
216950870
Labeler code
21695
Product ID
21695-870_fbc8717c-8980-4cab-9518-84eb732df072
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA021282
Marketing category
NDA
Marketing start
2009-03-27
Marketing end
0000-00-00
Substance
GUAIFENESIN
Active strength
600 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-870-202019-09-24C16284748780-1934fe258-49c8-48b1-e053-8cdaa90a720aMucinex ®
21695-870-402019-09-24C16284748780-1934fe258-49c8-48b1-e053-8cdaa90a720aMucinex ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-870-20Mucinex10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE102
21695-870-20Mucinex2 in 1 CARTONTABLET, EXTENDED RELEASE22
21695-870-40Mucinex4 in 1 CARTONTABLET, EXTENDED RELEASE42
21695-870-40Mucinex10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-870-20EA - Each21695-870a71cf3dd-6df0-45d9-9087-030cea7c541912012-07-24
21695-870-40EA - Each21695-870c788183e-cae4-43ca-b5b2-eb3c3e32401512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GuaifenesinACTIVE INGREDIENT495W7451VQMUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
GuaifenesinACTIVE MOIETY495W7451VQMUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
CARBOMER 934INACTIVE INGREDIENTZ135WT9208MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-870MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]2Legacy NDC, 4 package rows20120223_e4ac51f1-9b5e-49ad-ac79-dde6e91b65e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSNe4ac51f1-9b5e-49ad-ac79-dde6e91b65e92
891301Mucinex Expectorant 600 MG 12HR Extended Release Oral TabletPSNe4ac51f1-9b5e-49ad-ac79-dde6e91b65e92
89130112 HR guaifenesin 600 MG Extended Release Oral Tablet [Mucinex]SBDe4ac51f1-9b5e-49ad-ac79-dde6e91b65e92
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCDe4ac51f1-9b5e-49ad-ac79-dde6e91b65e92
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSYe4ac51f1-9b5e-49ad-ac79-dde6e91b65e92
891301Mucinex 600 MG 12 HR Extended Release Oral TabletSYe4ac51f1-9b5e-49ad-ac79-dde6e91b65e92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-870-202169508702010 in 1 BLISTER PACKHistorical
21695-870-40216950870404 in 1 CARTONHistorical