FDA.reportPublic FDA data

Monistat 1 Combination Pack

Product NDC
63736-014
11-digit product format
637360014
Labeler code
63736
Product ID
63736-014_f4d0fb63-ff03-4d5a-9f11-2e04fbb0823b
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
KIT
Labeler
Insight Pharmaceuticals
Application
NDA021308
Marketing category
NDA
Marketing start
2001-06-29
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
63736-014-032020-01-31C16284748780-19d75b9d0-5c02-f424-e053-dadaa90a57ceMonistat ® 1 Combination Pack

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-014-03Monistat 1 Combination Pack1 in 1 PACKAGE, COMBINATIONKIT12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1KMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
MiconazoleACTIVE MOIETY7NNO0D7S5MMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Benzoic AcidINACTIVE INGREDIENT8SKN0B0MIMMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
GelatinINACTIVE INGREDIENT2G86QN327LMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Isopropyl MyristateINACTIVE INGREDIENT0RE8K4LNJSMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Mineral OilINACTIVE INGREDIENTT5L8T28FGPMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
PetrolatumINACTIVE INGREDIENT4T6H12BN9UMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Polysorbate 60INACTIVE INGREDIENTCAL22UVI4MMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Potassium HydroxideINACTIVE INGREDIENTWZH3C48M4TMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3MONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
WaterINACTIVE INGREDIENT059QF0KO0RMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-014MONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2Legacy NDC, 1 package rows20130311_5ab8b34f-08cb-4d55-9971-3ffc00c7dc4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992778{1 (miconazole nitrate 1200 MG Vaginal Insert [Monistat]) / 1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]) } Pack [Monistat 1 Day Ovule Combination Pack]BPCK5ab8b34f-08cb-4d55-9971-3ffc00c7dc4e2
992775{1 (miconazole nitrate 1200 MG Vaginal Insert) / 1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) } PackGPCK5ab8b34f-08cb-4d55-9971-3ffc00c7dc4e2
992775miconazole 1 day - (1200 MG insert / 2 % cream 9 GM) PackPSN5ab8b34f-08cb-4d55-9971-3ffc00c7dc4e2
992774miconazole nitrate 1200 MG Vaginal InsertPSN5ab8b34f-08cb-4d55-9971-3ffc00c7dc4e2
998540miconazole nitrate 2 % Vaginal CreamPSN5ab8b34f-08cb-4d55-9971-3ffc00c7dc4e2
992778Monistat 1 Day Ovule Combination PackPSN5ab8b34f-08cb-4d55-9971-3ffc00c7dc4e2
992777Monistat 1200 MG Vaginal InsertPSN5ab8b34f-08cb-4d55-9971-3ffc00c7dc4e2
998541Monistat 2 % Vaginal CreamPSN5ab8b34f-08cb-4d55-9971-3ffc00c7dc4e2
992777miconazole nitrate 1200 MG Vaginal Insert [Monistat]SBD5ab8b34f-08cb-4d55-9971-3ffc00c7dc4e2
998541miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]SBD5ab8b34f-08cb-4d55-9971-3ffc00c7dc4e2
992774miconazole nitrate 1200 MG Vaginal InsertSCD5ab8b34f-08cb-4d55-9971-3ffc00c7dc4e2
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD5ab8b34f-08cb-4d55-9971-3ffc00c7dc4e2
992778{1 (miconazole nitrate 1200 MG Vaginal Insert [Monistat]) / 1 (0.32 OZ) (miconazole nitrate 2 % Vaginal Cream [Monistat]) } Pack [Monistat 1 Day Ovule Combination Pack]SY5ab8b34f-08cb-4d55-9971-3ffc00c7dc4e2
992774miconazole nitrate 1.2 GM Vaginal InsertSY5ab8b34f-08cb-4d55-9971-3ffc00c7dc4e2
998540miconazole nitrate 2 % Vaginal CreamSY5ab8b34f-08cb-4d55-9971-3ffc00c7dc4e2
992778Monistat 1 Day Ovule Combination PackSY5ab8b34f-08cb-4d55-9971-3ffc00c7dc4e2
992777Monistat 1200 MG Vaginal InsertSY5ab8b34f-08cb-4d55-9971-3ffc00c7dc4e2
998541Monistat 20 MG/ML Vaginal CreamSY5ab8b34f-08cb-4d55-9971-3ffc00c7dc4e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63736-014-03637360014031 in 1 PACKAGE, COMBINATIONHistorical