Monistat 3 Combination Pack

Product NDC
63736-019
11-digit product format
637360019
Labeler code
63736
Product ID
63736-019_9fd5cf39-5662-42fa-8d8c-8b96dce19875
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
KIT
Labeler
Insight Pharmaceuticals LLC
Application
NDA020670
Marketing category
NDA
Marketing start
1996-04-16
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Monistat 3 Combination Pack
Brand name suffix
3 Ovule Inserts
Listing expiration
2027-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui992765, 992766, 992770, 992771, 998540, 998541

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-019-03Monistat 3 Combination Pack3 Ovule Inserts1 in 1 PACKAGE, COMBINATIONKIT15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1KMONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]1
MiconazoleACTIVE MOIETY7NNO0D7S5MMONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]1
Benzoic AcidINACTIVE INGREDIENT8SKN0B0MIMMONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]1
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNMONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]1
GelatinINACTIVE INGREDIENT2G86QN327LMONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXMONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]1
Isopropyl MyristateINACTIVE INGREDIENT0RE8K4LNJSMONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]1
Polysorbate 60INACTIVE INGREDIENTCAL22UVI4MMONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]1
Potassium HydroxideINACTIVE INGREDIENTWZH3C48M4TMONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]1
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YMONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPMONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]1
WaterINACTIVE INGREDIENT059QF0KO0RMONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-019MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 1 package rows20240418_910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd.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]BPCK910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd5
992766{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (miconazole nitrate 200 MG Vaginal Insert) } PackGPCK910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd5
998540miconazole nitrate 2 % Vaginal CreamPSN910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd5
992765miconazole nitrate 200 MG Vaginal InsertPSN910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd5
992766miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) PackPSN910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd5
998541Monistat 2 % Vaginal CreamPSN910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd5
992770Monistat 3 200 MG Vaginal InsertPSN910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd5
992771Monistat 3 Day Ovule Combination PackPSN910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd5
998541miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]SBD910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd5
992770miconazole nitrate 200 MG Vaginal Insert [Monistat]SBD910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd5
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd5
992765miconazole nitrate 200 MG Vaginal InsertSCD910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd5
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]SY910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd5
992766miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)SY910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd5
992766miconazole 3 Day Vaginal Insert Combination PackSY910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd5
998540miconazole nitrate 2 % Vaginal CreamSY910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd5
998541Monistat 20 MG/ML Vaginal CreamSY910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd5
992770Monistat 200 MG Vaginal InsertSY910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd5
992771Monistat 3 Day Ovule Combination PackSY910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63736-019-03637360019031 KIT in 1 PACKAGE, COMBINATION (63736-019-03) * 3 SUPPOSITORY in 1 KIT * 9 g in 1 TUBE1 kit1996-04-160000-00-00NoNoCurrent