FDA.reportPublic FDA data

Monistat 3 Combination Pack

Product NDC
63736-010
11-digit product format
637360010
Labeler code
63736
Product ID
63736-010_03108766-1001-4aac-9dd8-799a63662a25
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
KIT
Labeler
Insight Pharmaceuticals LLC
Application
NDA021261
Marketing category
NDA
Marketing start
2009-12-10
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Monistat 3 Combination Pack
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui992816, 998540, 998541, 998544, 998546, 1536604

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
63736-010-01Monistat 3 Combination Pack1 in 1 PACKAGE, COMBINATIONKIT19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-010MONISTAT 3 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS LLC]7Current NDC, Legacy NDC, 1 package rows20241122_e1b8ad40-5adb-482a-b532-3f8e30d90128.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1536604{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]) / 3 (5000 MG) (miconazole nitrate 40 MG/ML Vaginal Cream [Monistat]) } Pack [Monistat 3 Vaginal Cream Combination Pack with Vaginal Creams]BPCKe1b8ad40-5adb-482a-b532-3f8e30d901289
992816{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (5000 MG) (miconazole nitrate 40 MG/ML Vaginal Cream) } PackGPCKe1b8ad40-5adb-482a-b532-3f8e30d901289
992816miconazole 3 Day - (4 % applicator 5 GM / 2 % cream 9 GM) PackPSNe1b8ad40-5adb-482a-b532-3f8e30d901289
998540miconazole nitrate 2 % Vaginal CreamPSNe1b8ad40-5adb-482a-b532-3f8e30d901289
998544miconazole nitrate 4 % Vaginal CreamPSNe1b8ad40-5adb-482a-b532-3f8e30d901289
998541Monistat 2 % Vaginal CreamPSNe1b8ad40-5adb-482a-b532-3f8e30d901289
998546MONISTAT 3 4 % Vaginal CreamPSNe1b8ad40-5adb-482a-b532-3f8e30d901289
1536604Monistat 3 Vaginal Cream and Topical Cream Combination Pack with Prefilled ApplicatorsPSNe1b8ad40-5adb-482a-b532-3f8e30d901289
998541miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]SBDe1b8ad40-5adb-482a-b532-3f8e30d901289
998546miconazole nitrate 40 MG/ML Vaginal Cream [Monistat]SBDe1b8ad40-5adb-482a-b532-3f8e30d901289
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDe1b8ad40-5adb-482a-b532-3f8e30d901289
998544miconazole nitrate 40 MG/ML Vaginal CreamSCDe1b8ad40-5adb-482a-b532-3f8e30d901289
992816{3 (5 GM miconazole nitrate 200 MG (4 % ) Prefilled Applicator) / 1 (9 GM miconazole nitrate 2 % Vaginal Cream) } PackSYe1b8ad40-5adb-482a-b532-3f8e30d901289
992816{3 (5000 MG miconazole nitrate 4 % Prefilled Applicator) / 1 (0.32 OZ miconazole nitrate 2 % Vaginal Cream) } PackSYe1b8ad40-5adb-482a-b532-3f8e30d901289
992816Miconazole 3 Day Prefilled Applicator Combination PackSYe1b8ad40-5adb-482a-b532-3f8e30d901289
998540miconazole nitrate 2 % Vaginal CreamSYe1b8ad40-5adb-482a-b532-3f8e30d901289
998544miconazole nitrate 4 % Vaginal CreamSYe1b8ad40-5adb-482a-b532-3f8e30d901289
998541Monistat 20 MG/ML Vaginal CreamSYe1b8ad40-5adb-482a-b532-3f8e30d901289
1536604Monistat 3 Vaginal Cream and Topical Cream Combination Pack with Prefilled ApplicatorsSYe1b8ad40-5adb-482a-b532-3f8e30d901289
998546Monistat 4 % Vaginal CreamSYe1b8ad40-5adb-482a-b532-3f8e30d901289
998546Monistat 40 MG/ML Vaginal CreamSYe1b8ad40-5adb-482a-b532-3f8e30d901289

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63736-010-01637360010011 KIT in 1 PACKAGE, COMBINATION (63736-010-01) * 5 g in 1 APPLICATOR * 9 g in 1 TUBE1 kit2009-12-100000-00-00NoNoCurrent