FDA.reportPublic FDA data

Miconazole 1 Combination Pack

Product NDC
51316-005
Requested package NDC
51316-005-01
11-digit product format
513160005
Labeler code
51316
Product ID
51316-005_ceb2e359-e195-4a2c-82ea-9dd13cebcbeb
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
KIT
Labeler
CVS PHARMACY, INC
Application
NDA020670
Marketing category
NDA
Marketing start
2022-01-30
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
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
4cbf37d1-023d-496f-84c8-a1b2a83a10efAvailable 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
51316-005-012023-01-30C16284748780-1f386c64a-3016-0266-e053-dadaa90a7c1aMiconazole 1 Combination Pack

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-005-01Miconazole 1 Combination Pack1 in 1 PACKAGE, COMBINATIONKIT12
51316-090-01Miconazole 1 Combination Pack1 in 1 POUCHSUPPOSITORY11200 mg2
51316-091-01Miconazole 1 Combination Pack9 g in 1 TUBECREAM9 g20 mg in 1g2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-005MICONAZOLE 1 COMBINATION PACK (MICONAZOLE NITRATE) KIT [CVS PHARMACY, INC]1Current NDC, Legacy NDC, 3 package rows20220130_4cbf37d1-023d-496f-84c8-a1b2a83a10ef.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
ndc (package): 51316-005-01
ndc (product): 51316-005
ndc11 (package): 51316000501
MONISTAT 3MICONAZOLE NITRATEInsight Pharmaceuticals LLC674f2e66-e7e3-40ff-aa21-adaf5d55dcda2025-11-04WarningsExact identifier
application applno (NDA): 020670
application number: NDA020670
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
992775{1 (miconazole nitrate 1200 MG Vaginal Insert) / 1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) } PackGPCK4cbf37d1-023d-496f-84c8-a1b2a83a10ef2
992775miconazole 1 day - (1200 MG insert / 2 % cream 9 GM) PackPSN4cbf37d1-023d-496f-84c8-a1b2a83a10ef2
992774miconazole nitrate 1200 MG Vaginal InsertPSN4cbf37d1-023d-496f-84c8-a1b2a83a10ef2
998540miconazole nitrate 2 % Vaginal CreamPSN4cbf37d1-023d-496f-84c8-a1b2a83a10ef2
992774miconazole nitrate 1200 MG Vaginal InsertSCD4cbf37d1-023d-496f-84c8-a1b2a83a10ef2
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD4cbf37d1-023d-496f-84c8-a1b2a83a10ef2
992774miconazole nitrate 1.2 GM Vaginal InsertSY4cbf37d1-023d-496f-84c8-a1b2a83a10ef2
998540miconazole nitrate 2 % Vaginal CreamSY4cbf37d1-023d-496f-84c8-a1b2a83a10ef2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51316-005-01513160005011 KIT in 1 PACKAGE, COMBINATION (51316-005-01) * 9 g in 1 TUBE (51316-091-01) * 1 SUPPOSITORY in 1 POUCH (51316-090-01) 1 kit2022-01-300000-00-00NoNoCurrent