FDA.reportPublic FDA data

Monistat 3 Combination Pack

Product NDC
63736-018
11-digit product format
637360018
Labeler code
63736
Product ID
63736-018_d2d67e80-0b22-4ecd-b721-5d259e90fc3a
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
KIT
Labeler
Insight Pharmaceuticals
Application
NDA020670
Marketing category
NDA
Marketing start
2009-12-10
Marketing end
0000-00-00
Active strength
0
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63736-018-032020-01-31C16284748780-19d75b9d0-e18b-f424-e053-dadaa90a57ceMONISTAT® 3 COMBINATION PACK

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-018-03Monistat 3 Combination Pack1 in 1 PACKAGE, COMBINATIONKIT12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1KMONISTAT 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
MiconazoleACTIVE MOIETY7NNO0D7S5MMONISTAT 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Benzoic AcidINACTIVE INGREDIENT8SKN0B0MIMMONISTAT 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNMONISTAT 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
HYDROGENATED COCONUT OILINACTIVE INGREDIENTJY81OXM1OMMONISTAT 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
HYDROGENATED PALM KERNEL OILINACTIVE INGREDIENTFM8D1RE2VPMONISTAT 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Isopropyl MyristateINACTIVE INGREDIENT0RE8K4LNJSMONISTAT 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Polysorbate 60INACTIVE INGREDIENTCAL22UVI4MMONISTAT 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Potassium HydroxideINACTIVE INGREDIENTWZH3C48M4TMONISTAT 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Propylene glycolINACTIVE INGREDIENT6DC9Q167V3MONISTAT 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YMONISTAT 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
WaterINACTIVE INGREDIENT059QF0KO0RMONISTAT 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-018MONISTAT 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2Legacy NDC, 1 package rows20120822_153d0891-1770-4825-aa03-1bd6c504812a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1536604{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]) / 3 (5000 MG) (miconazole nitrate 40 MG/ML Vaginal Cream [Monistat]) } Pack [Monistat 3 Vaginal Cream Combination Pack with Vaginal Creams]BPCK153d0891-1770-4825-aa03-1bd6c504812a2
992816{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (5000 MG) (miconazole nitrate 40 MG/ML Vaginal Cream) } PackGPCK153d0891-1770-4825-aa03-1bd6c504812a2
992816miconazole 3 Day - (4 % applicator 5 GM / 2 % cream 9 GM) PackPSN153d0891-1770-4825-aa03-1bd6c504812a2
998540miconazole nitrate 2 % Vaginal CreamPSN153d0891-1770-4825-aa03-1bd6c504812a2
992765miconazole nitrate 200 MG Vaginal InsertPSN153d0891-1770-4825-aa03-1bd6c504812a2
998544miconazole nitrate 4 % Vaginal CreamPSN153d0891-1770-4825-aa03-1bd6c504812a2
998541Monistat 2 % Vaginal CreamPSN153d0891-1770-4825-aa03-1bd6c504812a2
992770Monistat 3 200 MG Vaginal InsertPSN153d0891-1770-4825-aa03-1bd6c504812a2
998546MONISTAT 3 4 % Vaginal CreamPSN153d0891-1770-4825-aa03-1bd6c504812a2
1536604Monistat 3 Vaginal Cream and Topical Cream Combination Pack with Prefilled ApplicatorsPSN153d0891-1770-4825-aa03-1bd6c504812a2
998541miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]SBD153d0891-1770-4825-aa03-1bd6c504812a2
992770miconazole nitrate 200 MG Vaginal Insert [Monistat]SBD153d0891-1770-4825-aa03-1bd6c504812a2
998546miconazole nitrate 40 MG/ML Vaginal Cream [Monistat]SBD153d0891-1770-4825-aa03-1bd6c504812a2
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD153d0891-1770-4825-aa03-1bd6c504812a2
992765miconazole nitrate 200 MG Vaginal InsertSCD153d0891-1770-4825-aa03-1bd6c504812a2
998544miconazole nitrate 40 MG/ML Vaginal CreamSCD153d0891-1770-4825-aa03-1bd6c504812a2
992816{3 (5 GM miconazole nitrate 200 MG (4 % ) Prefilled Applicator) / 1 (9 GM miconazole nitrate 2 % Vaginal Cream) } PackSY153d0891-1770-4825-aa03-1bd6c504812a2
992816{3 (5000 MG miconazole nitrate 4 % Prefilled Applicator) / 1 (0.32 OZ miconazole nitrate 2 % Vaginal Cream) } PackSY153d0891-1770-4825-aa03-1bd6c504812a2
992816Miconazole 3 Day Prefilled Applicator Combination PackSY153d0891-1770-4825-aa03-1bd6c504812a2
998540miconazole nitrate 2 % Vaginal CreamSY153d0891-1770-4825-aa03-1bd6c504812a2
998544miconazole nitrate 4 % Vaginal CreamSY153d0891-1770-4825-aa03-1bd6c504812a2
998541Monistat 20 MG/ML Vaginal CreamSY153d0891-1770-4825-aa03-1bd6c504812a2
992770Monistat 200 MG Vaginal InsertSY153d0891-1770-4825-aa03-1bd6c504812a2
1536604Monistat 3 Vaginal Cream and Topical Cream Combination Pack with Prefilled ApplicatorsSY153d0891-1770-4825-aa03-1bd6c504812a2
998546Monistat 4 % Vaginal CreamSY153d0891-1770-4825-aa03-1bd6c504812a2
998546Monistat 40 MG/ML Vaginal CreamSY153d0891-1770-4825-aa03-1bd6c504812a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63736-018-03637360018031 in 1 PACKAGE, COMBINATIONHistorical