FDA.reportPublic FDA data

MUCINEX

Product NDC
55045-3143
11-digit product format
550453143
Labeler code
55045
Product ID
55045-3143_20baf571-544d-4945-b3dc-b905a54ec7bd
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
NDA021282
Marketing category
NDA
Marketing start
2010-05-12
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55045-3143-22019-10-29C16284748780-1960f7f55-ccb0-8e05-e053-dbdaa90a074aMucinex ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55045-3143-2MUCINEX20 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55045-3143-2EA - Each55045-3143d0b4d890-44ce-42bc-931d-673a9798a6ef12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
GUAIFENESINACTIVE MOIETY495W7451VQMUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
CARBOMER HOMOPOLYMER TYPE BINACTIVE INGREDIENTHHT01ZNK31MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55045-3143MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 1 package rows20110630_6c53cc58-aaab-49f5-8d61-7ce2681bc6a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN6c53cc58-aaab-49f5-8d61-7ce2681bc6a81
891301Mucinex Expectorant 600 MG 12HR Extended Release Oral TabletPSN6c53cc58-aaab-49f5-8d61-7ce2681bc6a81
89130112 HR guaifenesin 600 MG Extended Release Oral Tablet [Mucinex]SBD6c53cc58-aaab-49f5-8d61-7ce2681bc6a81
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD6c53cc58-aaab-49f5-8d61-7ce2681bc6a81
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY6c53cc58-aaab-49f5-8d61-7ce2681bc6a81
891301Mucinex 600 MG 12 HR Extended Release Oral TabletSY6c53cc58-aaab-49f5-8d61-7ce2681bc6a81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55045-3143-25504531430220 in 1 BOTTLE, PLASTICHistorical