FDA.reportPublic FDA data

Miconazole 3

Product NDC
11822-0800
11-digit product format
118220800
Labeler code
11822
Product ID
11822-0800_dee71a79-f716-4179-99f6-117a793f3b1a
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
KIT
Labeler
Rite Aid Corporation
Application
ANDA076357
Marketing category
ANDA
Marketing start
2014-02-12
Marketing end
2026-11-30
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
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
Miconazole 3

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
78b6ac87-3de0-44e9-9e28-b4c7ab028fd5Available 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
11822-0800-0Miconazole 31 in 1 CARTONKIT15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [RITE AID CORPORATION]1
MICONAZOLEACTIVE MOIETY7NNO0D7S5MMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [RITE AID CORPORATION]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [RITE AID CORPORATION]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [RITE AID CORPORATION]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [RITE AID CORPORATION]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [RITE AID CORPORATION]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [RITE AID CORPORATION]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [RITE AID CORPORATION]1
PEG-5 OLEATEINACTIVE INGREDIENT0240V77G50MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [RITE AID CORPORATION]1
PEGOXOL 7 STEARATEINACTIVE INGREDIENT3EW5AXE5X5MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [RITE AID CORPORATION]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [RITE AID CORPORATION]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [RITE AID CORPORATION]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [RITE AID CORPORATION]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [RITE AID CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [RITE AID CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0800MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [RITE AID CORPORATION]5Current NDC, Legacy NDC, 1 package rows20240622_78b6ac87-3de0-44e9-9e28-b4c7ab028fd5.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
ndc (product): 11822-0800
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
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) } PackGPCK78b6ac87-3de0-44e9-9e28-b4c7ab028fd55
992816miconazole 3 Day - (4 % applicator 5 GM / 2 % cream 9 GM) PackPSN78b6ac87-3de0-44e9-9e28-b4c7ab028fd55
998483miconazole nitrate 2 % Topical CreamPSN78b6ac87-3de0-44e9-9e28-b4c7ab028fd55
998540miconazole nitrate 2 % Vaginal CreamPSN78b6ac87-3de0-44e9-9e28-b4c7ab028fd55
998544miconazole nitrate 4 % Vaginal CreamPSN78b6ac87-3de0-44e9-9e28-b4c7ab028fd55
998483miconazole nitrate 20 MG/ML Topical CreamSCD78b6ac87-3de0-44e9-9e28-b4c7ab028fd55
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD78b6ac87-3de0-44e9-9e28-b4c7ab028fd55
998544miconazole nitrate 40 MG/ML Vaginal CreamSCD78b6ac87-3de0-44e9-9e28-b4c7ab028fd55
992816{3 (5 GM miconazole nitrate 200 MG (4 % ) Prefilled Applicator) / 1 (9 GM miconazole nitrate 2 % Vaginal Cream) } PackSY78b6ac87-3de0-44e9-9e28-b4c7ab028fd55
992816{3 (5000 MG miconazole nitrate 4 % Prefilled Applicator) / 1 (0.32 OZ miconazole nitrate 2 % Vaginal Cream) } PackSY78b6ac87-3de0-44e9-9e28-b4c7ab028fd55
992816Miconazole 3 Day Prefilled Applicator Combination PackSY78b6ac87-3de0-44e9-9e28-b4c7ab028fd55
998483miconazole nitrate 2 % Topical CreamSY78b6ac87-3de0-44e9-9e28-b4c7ab028fd55
998540miconazole nitrate 2 % Vaginal CreamSY78b6ac87-3de0-44e9-9e28-b4c7ab028fd55
998544miconazole nitrate 4 % Vaginal CreamSY78b6ac87-3de0-44e9-9e28-b4c7ab028fd55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0800-0118220800001 KIT in 1 CARTON (11822-0800-0) * 1 APPLICATOR in 1 POUCH / 5 g in 1 APPLICATOR * 1 TUBE in 1 CARTON / 9 g in 1 TUBE1 kit2014-02-120000-00-00NoNoCurrent