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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)MICONAZOLE NITRATE2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-02
N021261-003MONISTAT 3 COMBINATION PACKMICONAZOLE NITRATE2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-17

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-0284e616aacf4f…
2026-09-14 22:38:342026-08N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-1784e616aacf4f…
2026-08-18 06:07:402026-07N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-02caaa826d4ba7…
2026-08-18 06:07:402026-07N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021261-001MONISTAT 3 COMBINATION PACK (PREFILLED)2%,4%CREAM / TOPICAL, VAGINALRLD, RS2001-02-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021261-003MONISTAT 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINALRLD2003-06-1774a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
992816Internal RxNorm lookup
998540Internal RxNorm lookup
998541Internal RxNorm lookup
998544Internal RxNorm lookup
998546Internal RxNorm lookup
1536604Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e1b8ad40-5adb-482a-b532-3f8e30d90128Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Monistat 3 Combination PackMICONAZOLE NITRATEInsight Pharmaceuticals LLCe1b8ad40-5adb-482a-b532-3f8e30d901282025-10-27WarningsExact identifier
application applno (NDA): 021261
application number: NDA021261
ndc (product): 63736-010

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