FDA.reportPublic FDA data

CVS MICONAZOLE 1 COMBINATION PACK

Product NDC
51316-093
11-digit product format
513160093
Labeler code
51316
Product ID
51316-093_0a2c3afd-9556-4ab3-87bd-1720ffa32af5
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
KIT
Labeler
CVS PHARMACY, INC
Application
NDA021308
Marketing category
NDA
Marketing start
2022-01-30
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 42.

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29caaa826d4ba7…
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…

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
CVS MICONAZOLE 1 COMBINATION PACK
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
992774Internal RxNorm lookup
992775Internal RxNorm lookup
998540Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
db40f672-62b4-4844-a2d3-7e8617c40ec9Available 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
51316-093-01CVS MICONAZOLE 1 COMBINATION PACK1 in 1 PACKAGE, COMBINATIONKIT11
51316-094-01CVS MICONAZOLE 1 COMBINATION PACK1 in 1 POUCHSUPPOSITORY11200 mg1
51316-095-01CVS MICONAZOLE 1 COMBINATION PACK9 g in 1 TUBECREAM9 g20 mg in 1g1

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
CVS MICONAZOLE 1 COMBINATION PACKMICONAZOLE NITRATECVS PHARMACY, INCdb40f672-62b4-4844-a2d3-7e8617c40ec92026-03-24WarningsExact identifier
application applno (NDA): 021308
application number: NDA021308
ndc (product): 51316-093

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992775{1 (miconazole nitrate 1200 MG Vaginal Insert) / 1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) } PackGPCKdb40f672-62b4-4844-a2d3-7e8617c40ec91
992775miconazole 1 day - (1200 MG insert / 2 % cream 9 GM) PackPSNdb40f672-62b4-4844-a2d3-7e8617c40ec91
992774miconazole nitrate 1200 MG Vaginal InsertPSNdb40f672-62b4-4844-a2d3-7e8617c40ec91
998540miconazole nitrate 2 % Vaginal CreamPSNdb40f672-62b4-4844-a2d3-7e8617c40ec91
992774miconazole nitrate 1200 MG Vaginal InsertSCDdb40f672-62b4-4844-a2d3-7e8617c40ec91
998540miconazole nitrate 20 MG/ML Vaginal CreamSCDdb40f672-62b4-4844-a2d3-7e8617c40ec91
992774miconazole nitrate 1.2 GM Vaginal InsertSYdb40f672-62b4-4844-a2d3-7e8617c40ec91
998540miconazole nitrate 2 % Vaginal CreamSYdb40f672-62b4-4844-a2d3-7e8617c40ec91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-093-01513160093011 KIT in 1 PACKAGE, COMBINATION (51316-093-01) * 1 SUPPOSITORY in 1 POUCH (51316-094-01) * 9 g in 1 TUBE (51316-095-01) 1 kit2022-01-30NoNoCurrent
51316-094-01513160094011 in 1 POUCHHistorical
51316-095-01513160095019 g in 1 TUBE9 gHistorical