Monistat 7 Combination Pack

Product NDC
63736-023
11-digit product format
637360023
Labeler code
63736
Product ID
63736-023_c4195b56-36a3-4584-8d1c-3aed7c4bbbbd
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
KIT
Labeler
Insight Pharmaceuticals LLC
Application
NDA017450
Marketing category
NDA
Marketing start
1993-04-26
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Monistat 7 Combination Pack
Brand name suffix
7-Day Pre-Filled Applicators
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui998540, 998541, 1536610, 1854816

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
63736-023-15Monistat 7 Combination Pack7-Day Pre-Filled Applicators1 in 1 PACKAGE, COMBINATIONKIT16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1KMONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]1
MiconazoleACTIVE MOIETY7NNO0D7S5MMONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]1
Benzoic AcidINACTIVE INGREDIENT8SKN0B0MIMMONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]1
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNMONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]1
Isopropyl MyristateINACTIVE INGREDIENT0RE8K4LNJSMONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]1
Polysorbate 60INACTIVE INGREDIENTCAL22UVI4MMONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]1
Potassium HydroxideINACTIVE INGREDIENTWZH3C48M4TMONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3MONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]1
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YMONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]1
WaterINACTIVE INGREDIENT059QF0KO0RMONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-023MONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS LLC]5Current NDC, Legacy NDC, 1 package rows20241109_9b1ac735-9b18-48c2-86dc-93d07157d5e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1536610{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]) / 7 (5000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]) } Pack [Monistat 7 Vaginal Cream Combination Pack with Vaginal Creams]BPCK9b1ac735-9b18-48c2-86dc-93d07157d5e56
1854816{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 7 (5000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) } PackGPCK9b1ac735-9b18-48c2-86dc-93d07157d5e56
1854816miconazole 7 Day - (2 % applicator 5 GM / 2 % cream 9 GM) PackPSN9b1ac735-9b18-48c2-86dc-93d07157d5e56
998540miconazole nitrate 2 % Vaginal CreamPSN9b1ac735-9b18-48c2-86dc-93d07157d5e56
998541Monistat 2 % Vaginal CreamPSN9b1ac735-9b18-48c2-86dc-93d07157d5e56
1536610Monistat 7 Vaginal Cream Combination Pack with Prefilled ApplicatorsPSN9b1ac735-9b18-48c2-86dc-93d07157d5e56
998541miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]SBD9b1ac735-9b18-48c2-86dc-93d07157d5e56
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD9b1ac735-9b18-48c2-86dc-93d07157d5e56
1854816miconazole 7 Day Prefilled Applicator Combination PackSY9b1ac735-9b18-48c2-86dc-93d07157d5e56
998540miconazole nitrate 2 % Vaginal CreamSY9b1ac735-9b18-48c2-86dc-93d07157d5e56
998541Monistat 20 MG/ML Vaginal CreamSY9b1ac735-9b18-48c2-86dc-93d07157d5e56
1536610Monistat 7 Vaginal Cream Combination Pack with Prefilled ApplicatorsSY9b1ac735-9b18-48c2-86dc-93d07157d5e56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63736-023-15637360023151 KIT in 1 PACKAGE, COMBINATION (63736-023-15) * 5 g in 1 TUBE, WITH APPLICATOR * 9 g in 1 TUBE1 kit1993-04-260000-00-00NoNoCurrent