MONISTAT 7

Product NDC
63736-026
11-digit product format
637360026
Labeler code
63736
Product ID
63736-026_a1b5cbdb-d256-47af-9df6-d80d9f9ac802
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
Insight Pharmaceuticals LLC
Application
NDA017450
Marketing category
NDA
Marketing start
1993-04-26
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
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
Brand name suffix
7-DAY DISPOSABLE APPLICATORS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998540, 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63736-026-152020-04-13C16284748780-19d75b9d0-5c35-f424-e053-dadaa90a57ceMonistat 7 Simply - 7 dispos apps-Cream
63736-026-152020-01-31C16284748780-19d75b9d0-5c35-f424-e053-dadaa90a57ceMonistat 7 Simply - 7 dispos apps-Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-026-15MONISTAT 77-DAY DISPOSABLE APPLICATORS45 g in 1 TUBE, WITH APPLICATORCREAM456
63736-026-15MONISTAT 77-DAY DISPOSABLE APPLICATORS7 in 1 CARTONCREAM76

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-026MONISTAT 7 7-DAY DISPOSABLE APPLICATORS (MICONAZOLE NITRATE) CREAM [INSIGHT PHARMACEUTICALS LLC]6Current NDC, Legacy NDC, 2 package rows20241109_c4b68aff-e95f-47ae-b190-6a671bef1877.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998540miconazole nitrate 2 % Vaginal CreamPSNc4b68aff-e95f-47ae-b190-6a671bef18776
998541Monistat 2 % Vaginal CreamPSNc4b68aff-e95f-47ae-b190-6a671bef18776
998541miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]SBDc4b68aff-e95f-47ae-b190-6a671bef18776
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDc4b68aff-e95f-47ae-b190-6a671bef18776
998540miconazole nitrate 2 % Vaginal CreamSYc4b68aff-e95f-47ae-b190-6a671bef18776
998541Monistat 20 MG/ML Vaginal CreamSYc4b68aff-e95f-47ae-b190-6a671bef18776

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63736-026-15637360026157 TUBE, WITH APPLICATOR in 1 CARTON (63736-026-15) / 45 g in 1 TUBE, WITH APPLICATOR1993-04-260000-00-00NoNoCurrent