FDA.reportPublic FDA data

Monistat 3 Combination Pack

Product NDC
63736-016
11-digit product format
637360016
Labeler code
63736
Product ID
63736-016_adba15db-7324-4621-be60-71a8b1f895df
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
KIT
Labeler
Insight Pharmaceuticals
Application
NDA020670
Marketing category
NDA
Marketing start
1996-04-16
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
63736-016-032020-01-31C16284748780-19d75b9cf-e80d-f424-e053-dadaa90a57ceMONISTAT®3 COMBINATION PACK

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-016-03Monistat 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
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
63736-016MONISTAT 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2Legacy NDC, 1 package rows20120822_7a138851-eb37-4ca3-909f-46492c844950.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992771{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]) / 3 (miconazole nitrate 200 MG Vaginal Insert [Monistat]) } Pack [Monistat 3 Day Ovule Combination Pack]BPCK7a138851-eb37-4ca3-909f-46492c8449502
992766{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (miconazole nitrate 200 MG Vaginal Insert) } PackGPCK7a138851-eb37-4ca3-909f-46492c8449502
998540miconazole nitrate 2 % Vaginal CreamPSN7a138851-eb37-4ca3-909f-46492c8449502
992765miconazole nitrate 200 MG Vaginal InsertPSN7a138851-eb37-4ca3-909f-46492c8449502
992766miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) PackPSN7a138851-eb37-4ca3-909f-46492c8449502
998541Monistat 2 % Vaginal CreamPSN7a138851-eb37-4ca3-909f-46492c8449502
992770Monistat 3 200 MG Vaginal InsertPSN7a138851-eb37-4ca3-909f-46492c8449502
992771Monistat 3 Day Ovule Combination PackPSN7a138851-eb37-4ca3-909f-46492c8449502
998541miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]SBD7a138851-eb37-4ca3-909f-46492c8449502
992770miconazole nitrate 200 MG Vaginal Insert [Monistat]SBD7a138851-eb37-4ca3-909f-46492c8449502
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD7a138851-eb37-4ca3-909f-46492c8449502
992765miconazole nitrate 200 MG Vaginal InsertSCD7a138851-eb37-4ca3-909f-46492c8449502
992771{1 (0.32 OZ) (miconazole nitrate 2 % Vaginal Cream [Monistat]) / 3 (miconazole nitrate 200 MG Vaginal Insert [Monistat]) } Pack [Monistat 3 Day Ovule Combination Pack]SY7a138851-eb37-4ca3-909f-46492c8449502
992766miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)SY7a138851-eb37-4ca3-909f-46492c8449502
992766miconazole 3 Day Vaginal Insert Combination PackSY7a138851-eb37-4ca3-909f-46492c8449502
998540miconazole nitrate 2 % Vaginal CreamSY7a138851-eb37-4ca3-909f-46492c8449502
998541Monistat 20 MG/ML Vaginal CreamSY7a138851-eb37-4ca3-909f-46492c8449502
992770Monistat 200 MG Vaginal InsertSY7a138851-eb37-4ca3-909f-46492c8449502
992771Monistat 3 Day Ovule Combination PackSY7a138851-eb37-4ca3-909f-46492c8449502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63736-016-03637360016031 in 1 PACKAGE, COMBINATIONHistorical