FDA.reportPublic FDA data

Mucinex

Product NDC
53808-0871
11-digit product format
538080871
Labeler code
53808
Product ID
53808-0871_857ee4e5-bcbf-4e1b-afb2-a98507a8d3bb
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA021282
Marketing category
NDA
Marketing start
2013-01-01
Marketing end
0000-00-00
Substance
GUAIFENESIN
Active strength
600 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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
53808-0871-22020-01-31C16284748780-19d75b9d0-ff8e-f424-e053-dadaa90a57ceMucinex ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0871-2Mucinex60 in 1 BLISTER PACKTABLET, EXTENDED RELEASE601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GUAIFENESINACTIVE MOIETY495W7451VQMUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTHHT01ZNK31MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0871MUCINEX (GUAIFENESIN) TABLET, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20140415_594ad1e6-4221-4a4a-89db-a214ddf8306e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN594ad1e6-4221-4a4a-89db-a214ddf8306e1
891301Mucinex Expectorant 600 MG 12HR Extended Release Oral TabletPSN594ad1e6-4221-4a4a-89db-a214ddf8306e1
89130112 HR guaifenesin 600 MG Extended Release Oral Tablet [Mucinex]SBD594ad1e6-4221-4a4a-89db-a214ddf8306e1
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD594ad1e6-4221-4a4a-89db-a214ddf8306e1
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY594ad1e6-4221-4a4a-89db-a214ddf8306e1
891301Mucinex 600 MG 12 HR Extended Release Oral TabletSY594ad1e6-4221-4a4a-89db-a214ddf8306e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0871-25380808710260 in 1 BLISTER PACKHistorical