FDA.reportPublic FDA data

MONISTAT 3

Product NDC
63736-017
11-digit product format
637360017
Labeler code
63736
Product ID
63736-017_dd4127f7-4f74-41fa-b170-d28fe5639cf5
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
KIT
Labeler
Insight Pharmaceuticals LLC
Application
NDA020670
Marketing category
NDA
Marketing start
1996-04-16
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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020670-002MONISTAT 3 COMBINATION PACKMICONAZOLE NITRATE2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-1687673890dc5c…
2021-03-12 10:30 UTC2021-03N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-163f01610625f2…
2019-09-15 20:21 UTC2019-09N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16b00525d2431f…
2019-07-19 19:46 UTC2019-07N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-163f0d92c62455…
2023-05-13 08:27 UTC2023-05N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16053a50430f4f…
2023-01-26 05:58 UTC2023-01N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
MONISTAT 3
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
992765Internal RxNorm lookup
992766Internal RxNorm lookup
992770Internal RxNorm lookup
992771Internal RxNorm lookup
998540Internal RxNorm lookup
998541Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
674f2e66-e7e3-40ff-aa21-adaf5d55dcdaAvailable 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
63736-017-03MONISTAT 31 in 1 PACKAGE, COMBINATIONKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-017MONISTAT 3 (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 1 package rows20240322_674f2e66-e7e3-40ff-aa21-adaf5d55dcda.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole 3 Walgreen CompanyMICONAZOLE NITRATEWALGREEN COMPANY32b373be-9c8e-49b0-a796-8d87f6a20cef2026-07-21WarningsExact identifier
application applno (NDA): 020670
application number: NDA020670
Monistat 3 Combination Pack 3 Ovule InsertsMICONAZOLE NITRATEInsight Pharmaceuticals LLC910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd2026-04-20WarningsExact identifier
application applno (NDA): 020670
application number: NDA020670
Miconazole 1 Combination PackMICONAZOLE NITRATECVS PHARMACY, INC4cbf37d1-023d-496f-84c8-a1b2a83a10ef2026-01-29WarningsExact identifier
application applno (NDA): 020670
application number: NDA020670
MONISTAT 3MICONAZOLE NITRATEInsight Pharmaceuticals LLC674f2e66-e7e3-40ff-aa21-adaf5d55dcda2025-11-04WarningsExact identifier
application applno (NDA): 020670
application number: NDA020670
ndc (product): 63736-017
Miconazole 3MICONAZOLE NITRATECVS Pharmacy6e027927-1532-46ba-8839-6ee4416d0b602017-01-06WarningsExact identifier
application applno (NDA): 020670
application number: NDA020670

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992771{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]) / 3 (miconazole nitrate 200 MG Vaginal Insert [Monistat]) } Pack [Monistat 3 Day Ovule Combination Pack]BPCK674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
992766{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (miconazole nitrate 200 MG Vaginal Insert) } PackGPCK674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
998540miconazole nitrate 2 % Vaginal CreamPSN674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
992765miconazole nitrate 200 MG Vaginal InsertPSN674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
992766miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) PackPSN674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
998541Monistat 2 % Vaginal CreamPSN674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
992770Monistat 3 200 MG Vaginal InsertPSN674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
992771Monistat 3 Day Ovule Combination PackPSN674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
998541miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]SBD674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
992770miconazole nitrate 200 MG Vaginal Insert [Monistat]SBD674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
992765miconazole nitrate 200 MG Vaginal InsertSCD674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
992771{1 (0.32 OZ) (miconazole nitrate 2 % Vaginal Cream [Monistat]) / 3 (miconazole nitrate 200 MG Vaginal Insert [Monistat]) } Pack [Monistat 3 Day Ovule Combination Pack]SY674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
992766miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)SY674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
992766miconazole 3 Day Vaginal Insert Combination PackSY674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
998540miconazole nitrate 2 % Vaginal CreamSY674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
998541Monistat 20 MG/ML Vaginal CreamSY674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
992770Monistat 200 MG Vaginal InsertSY674f2e66-e7e3-40ff-aa21-adaf5d55dcda3
992771Monistat 3 Day Ovule Combination PackSY674f2e66-e7e3-40ff-aa21-adaf5d55dcda3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63736-017-03637360017031 KIT in 1 PACKAGE, COMBINATION (63736-017-03) * 3 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE1 kit1996-04-160000-00-00NoNoCurrent