FDA.reportPublic FDA data

Monistat 1 Combination Pack

Product NDC
63736-013
11-digit product format
637360013
Labeler code
63736
Product ID
63736-013_50061b4b-e817-4ed7-8f2f-be4a17baf152
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
KIT
Labeler
Insight Pharmaceuticals LLC
Application
NDA021308
Marketing category
NDA
Marketing start
2001-06-29
NDC exclude flag
No
Listing certified through
2027-12-31
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
N021308-001MONISTAT 1 COMBINATION PACKMICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29

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 UTC2026-02N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS2001-06-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS2001-06-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS2001-06-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS2001-06-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS2001-06-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS2001-06-293f01610625f2…
2019-09-15 20:21 UTC2019-09N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS2001-06-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS2001-06-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29cb3db0bc1861…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021308-00161536352020-11-28Delist requested74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021308-00161536352020-11-28Delist requested8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021308-00161536352020-11-28Delist requestedc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021308-00161536352020-11-28Delist requested3f01610625f2…
2019-09-15 20:21 UTC2019-09N021308-00161536352020-11-28Delist requestedb00525d2431f…
2019-07-19 19:46 UTC2019-07N021308-00161536352020-11-28Delist requestedea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
Monistat 1 Combination Pack
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
992774Internal RxNorm lookup
992775Internal RxNorm lookup
992777Internal RxNorm lookup
992778Internal 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
97ff1c90-c250-4921-81af-6a56cc9cc7d2Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63736-013-302020-02-20C16284748780-19d75b9d0-9fd9-f424-e053-dadaa90a57ceMonistat 1 COMBINATION PACK_Suppository-tube_63736-013-30
63736-013-302020-01-31C16284748780-19d75b9d0-9fd9-f424-e053-dadaa90a57ceMonistat 1 COMBINATION PACK_Suppository-tube_63736-013-30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-013-30Monistat 1 Combination Pack1 in 1 PACKAGE, COMBINATIONKIT17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1KMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
MiconazoleACTIVE MOIETY7NNO0D7S5MMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Benzoic AcidINACTIVE INGREDIENT8SKN0B0MIMMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
GelatinINACTIVE INGREDIENT2G86QN327LMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Isopropyl MyristateINACTIVE INGREDIENT0RE8K4LNJSMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Mineral OilINACTIVE INGREDIENTT5L8T28FGPMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
PetrolatumINACTIVE INGREDIENT4T6H12BN9UMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Polysorbate 60INACTIVE INGREDIENTCAL22UVI4MMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Potassium HydroxideINACTIVE INGREDIENTWZH3C48M4TMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3MONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2
WaterINACTIVE INGREDIENT059QF0KO0RMONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-013MONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS LLC]5Current NDC, Legacy NDC, 1 package rows20241109_97ff1c90-c250-4921-81af-6a56cc9cc7d2.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole 1 WalgreensMICONAZOLE NITRATEWALGREEN COMPANY9679f4a5-c27b-46ea-9983-c2a111d3d2c32026-05-06WarningsExact identifier
application applno (NDA): 021308
application number: NDA021308
Monistat 1 Combination PackMICONAZOLE NITRATEInsight Pharmaceuticals LLC97ff1c90-c250-4921-81af-6a56cc9cc7d22026-04-20WarningsExact identifier
application applno (NDA): 021308
application number: NDA021308
ndc (product): 63736-013
CVS MICONAZOLE 1 COMBINATION PACKMICONAZOLE NITRATECVS PHARMACY, INCdb40f672-62b4-4844-a2d3-7e8617c40ec92026-03-24WarningsExact identifier
application applno (NDA): 021308
application number: NDA021308

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992778{1 (miconazole nitrate 1200 MG Vaginal Insert [Monistat]) / 1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]) } Pack [Monistat 1 Day Ovule Combination Pack]BPCK97ff1c90-c250-4921-81af-6a56cc9cc7d27
992775{1 (miconazole nitrate 1200 MG Vaginal Insert) / 1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) } PackGPCK97ff1c90-c250-4921-81af-6a56cc9cc7d27
992775miconazole 1 day - (1200 MG insert / 2 % cream 9 GM) PackPSN97ff1c90-c250-4921-81af-6a56cc9cc7d27
992774miconazole nitrate 1200 MG Vaginal InsertPSN97ff1c90-c250-4921-81af-6a56cc9cc7d27
998540miconazole nitrate 2 % Vaginal CreamPSN97ff1c90-c250-4921-81af-6a56cc9cc7d27
992778Monistat 1 Day Ovule Combination PackPSN97ff1c90-c250-4921-81af-6a56cc9cc7d27
992777Monistat 1200 MG Vaginal InsertPSN97ff1c90-c250-4921-81af-6a56cc9cc7d27
998541Monistat 2 % Vaginal CreamPSN97ff1c90-c250-4921-81af-6a56cc9cc7d27
992777miconazole nitrate 1200 MG Vaginal Insert [Monistat]SBD97ff1c90-c250-4921-81af-6a56cc9cc7d27
998541miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]SBD97ff1c90-c250-4921-81af-6a56cc9cc7d27
992774miconazole nitrate 1200 MG Vaginal InsertSCD97ff1c90-c250-4921-81af-6a56cc9cc7d27
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD97ff1c90-c250-4921-81af-6a56cc9cc7d27
992778{1 (miconazole nitrate 1200 MG Vaginal Insert [Monistat]) / 1 (0.32 OZ) (miconazole nitrate 2 % Vaginal Cream [Monistat]) } Pack [Monistat 1 Day Ovule Combination Pack]SY97ff1c90-c250-4921-81af-6a56cc9cc7d27
992774miconazole nitrate 1.2 GM Vaginal InsertSY97ff1c90-c250-4921-81af-6a56cc9cc7d27
998540miconazole nitrate 2 % Vaginal CreamSY97ff1c90-c250-4921-81af-6a56cc9cc7d27
992778Monistat 1 Day Ovule Combination PackSY97ff1c90-c250-4921-81af-6a56cc9cc7d27
992777Monistat 1200 MG Vaginal InsertSY97ff1c90-c250-4921-81af-6a56cc9cc7d27
998541Monistat 20 MG/ML Vaginal CreamSY97ff1c90-c250-4921-81af-6a56cc9cc7d27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63736-013-30637360013301 KIT in 1 PACKAGE, COMBINATION (63736-013-30) * 1 SUPPOSITORY in 1 POUCH * 9 g in 1 TUBE1 kit2001-06-290000-00-00NoNoCurrent