FDA.reportPublic FDA data

Up and Up Miconazole 3

Product NDC
11673-982
11-digit product format
116730982
Labeler code
11673
Product ID
11673-982_33261695-abd9-41ef-adf1-22d03aa7db8b
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
KIT
Labeler
Target Corporation
Application
ANDA076357
Marketing category
ANDA
Marketing start
2009-08-12
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
A076357-001MICONAZOLE 3 COMBINATION PACKMICONAZOLE NITRATE2%,4%CREAM / TOPICAL, VAGINAL2004-03-30

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 UTC2026-02A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-303f01610625f2…
2019-09-15 20:21 UTC2019-09A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076357-001MICONAZOLE 3 COMBINATION PACK2%,4%CREAM / TOPICAL, VAGINAL2004-03-30cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Up and Up Miconazole 3
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
992816Internal RxNorm lookup
998483Internal RxNorm lookup
998540Internal RxNorm lookup
998544Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9a186532-ee69-428e-98a9-8ee69f4d667aAvailable 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
11673-982-00Up and Up Miconazole 31 in 1 CARTONKIT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11673-982-00GM - Gram11673-9828e733734-f1d2-4026-891b-5ec571948ca722013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KUP AND UP MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [TARGET CORPORATION]1
MICONAZOLEACTIVE MOIETY7NNO0D7S5MUP AND UP MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [TARGET CORPORATION]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMUP AND UP MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [TARGET CORPORATION]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UUP AND UP MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [TARGET CORPORATION]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNUP AND UP MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [TARGET CORPORATION]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4UP AND UP MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [TARGET CORPORATION]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSUP AND UP MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [TARGET CORPORATION]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPUP AND UP MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [TARGET CORPORATION]1
PEGOXOL 7 STEARATEINACTIVE INGREDIENT3EW5AXE5X5UP AND UP MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [TARGET CORPORATION]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MUP AND UP MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [TARGET CORPORATION]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TUP AND UP MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [TARGET CORPORATION]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3UP AND UP MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [TARGET CORPORATION]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YUP AND UP MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [TARGET CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RUP AND UP MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [TARGET CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-982UP AND UP MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [TARGET CORPORATION]5Current NDC, Legacy NDC, 1 package rows20240618_9a186532-ee69-428e-98a9-8ee69f4d667a.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole 3MICONAZOLE NITRATERite Aid Corporation78b6ac87-3de0-44e9-9e28-b4c7ab028fd52026-07-07WarningsExact identifier
application applno (ANDA): 076357
application number: ANDA076357
Miconazole 3MICONAZOLE NITRATEMeijer Distribution Incc915a495-8eac-4a1a-83a4-c874682433c82026-05-07WarningsExact identifier
application applno (ANDA): 076357
application number: ANDA076357
Rugby Miconazole 3MICONAZOLE NITRATERugby Laboratories2d7035fa-9695-4d66-89f5-bd26420450ef2026-02-25WarningsExact identifier
application applno (ANDA): 076357
application number: ANDA076357
Up and Up Miconazole 3MICONAZOLE NITRATETarget Corporation9a186532-ee69-428e-98a9-8ee69f4d667a2026-01-30WarningsExact identifier
application applno (ANDA): 076357
application number: ANDA076357
ndc (product): 11673-982
foster and thrive miconazole 3MICONAZOLE NITRATEStrategic Sourcing Services LLC4c536e07-5e88-4bdd-a5b2-10226d5486ed2025-12-16WarningsExact identifier
application applno (ANDA): 076357
application number: ANDA076357
Leader Miconazole 3MICONAZOLE NITRATECardinal Health 110, LLC. dba Leader7f6df893-f404-4b2d-ab2b-696c8a2d36fa2025-09-29WarningsExact identifier
application applno (ANDA): 076357
application number: ANDA076357
Miconazole 3MICONAZOLE NITRATECVS Pharmacy9f506f59-e435-465d-90c7-9b0edc44160d2025-04-24WarningsExact identifier
application applno (ANDA): 076357
application number: ANDA076357

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992816{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (5000 MG) (miconazole nitrate 40 MG/ML Vaginal Cream) } PackGPCK9a186532-ee69-428e-98a9-8ee69f4d667a6
992816miconazole 3 Day - (4 % applicator 5 GM / 2 % cream 9 GM) PackPSN9a186532-ee69-428e-98a9-8ee69f4d667a6
998483miconazole nitrate 2 % Topical CreamPSN9a186532-ee69-428e-98a9-8ee69f4d667a6
998540miconazole nitrate 2 % Vaginal CreamPSN9a186532-ee69-428e-98a9-8ee69f4d667a6
998544miconazole nitrate 4 % Vaginal CreamPSN9a186532-ee69-428e-98a9-8ee69f4d667a6
998483miconazole nitrate 20 MG/ML Topical CreamSCD9a186532-ee69-428e-98a9-8ee69f4d667a6
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD9a186532-ee69-428e-98a9-8ee69f4d667a6
998544miconazole nitrate 40 MG/ML Vaginal CreamSCD9a186532-ee69-428e-98a9-8ee69f4d667a6
992816{3 (5 GM miconazole nitrate 200 MG (4 % ) Prefilled Applicator) / 1 (9 GM miconazole nitrate 2 % Vaginal Cream) } PackSY9a186532-ee69-428e-98a9-8ee69f4d667a6
992816{3 (5000 MG miconazole nitrate 4 % Prefilled Applicator) / 1 (0.32 OZ miconazole nitrate 2 % Vaginal Cream) } PackSY9a186532-ee69-428e-98a9-8ee69f4d667a6
992816Miconazole 3 Day Prefilled Applicator Combination PackSY9a186532-ee69-428e-98a9-8ee69f4d667a6
998483miconazole nitrate 2 % Topical CreamSY9a186532-ee69-428e-98a9-8ee69f4d667a6
998540miconazole nitrate 2 % Vaginal CreamSY9a186532-ee69-428e-98a9-8ee69f4d667a6
998544miconazole nitrate 4 % Vaginal CreamSY9a186532-ee69-428e-98a9-8ee69f4d667a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-982-00116730982001 KIT in 1 CARTON (11673-982-00) * 1 APPLICATOR in 1 POUCH / 5 g in 1 APPLICATOR * 1 TUBE in 1 CARTON / 9 g in 1 TUBE1 kit2009-08-120000-00-00NoNoCurrent