Monistat 7

Product NDC
63736-025
11-digit product format
637360025
Labeler code
63736
Product ID
63736-025_3db33d36-edb7-4a2f-aef6-93f10581452a
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
with Reusable Applicator
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-025-15Monistat 7with Reusable Applicator45 g in 1 TUBE, WITH APPLICATORCREAM455
63736-025-15Monistat 7with Reusable Applicator1 in 1 CARTONCREAM15

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-025MONISTAT 7 WITH REUSABLE APPLICATOR (MICONAZOLE NITRATE) CREAM [INSIGHT PHARMACEUTICALS LLC]4Current NDC, Legacy NDC, 2 package rows20241109_2aad40f2-4eea-441d-8b34-5613f1955405.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998540miconazole nitrate 2 % Vaginal CreamPSN2aad40f2-4eea-441d-8b34-5613f19554055
998541Monistat 2 % Vaginal CreamPSN2aad40f2-4eea-441d-8b34-5613f19554055
998541miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]SBD2aad40f2-4eea-441d-8b34-5613f19554055
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD2aad40f2-4eea-441d-8b34-5613f19554055
998540miconazole nitrate 2 % Vaginal CreamSY2aad40f2-4eea-441d-8b34-5613f19554055
998541Monistat 20 MG/ML Vaginal CreamSY2aad40f2-4eea-441d-8b34-5613f19554055

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63736-025-15637360025151 TUBE, WITH APPLICATOR in 1 CARTON (63736-025-15) / 45 g in 1 TUBE, WITH APPLICATOR1993-04-260000-00-00NoNoCurrent