topcare miconazole 1

Product NDC
36800-737
11-digit product format
368000737
Labeler code
36800
Product ID
36800-737_0b8926d0-7cfd-4817-b119-85c000e4e763
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
KIT
Labeler
Topco Associates LLC
Application
ANDA079114
Marketing category
ANDA
Marketing start
2010-06-15
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct36800-737DDiscontinued by firm2026-08-17
excluded packagepackage36800-73736800-737-45DDiscontinued by firm2026-08-17

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage36800-737-45d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage36800-737-45f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage36800-737-452ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage36800-737-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage36800-737-45cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage36800-737-45cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage36800-737-45302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage36800-737-45ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage36800-737-450efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage36800-737-45ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage36800-737-45367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage36800-737-45557ba5c1ecfa…9c80585c8c6e…

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
A079114-001MICONAZOLE NITRATEMICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02

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 06:07:402026-07A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINAL2010-06-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINAL2010-06-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINAL2010-06-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINAL2010-06-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINAL2010-06-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINAL2010-06-023f01610625f2…
2019-09-15 20:21 UTC2019-09A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINAL2010-06-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINAL2010-06-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02e64feba35796…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-737-45EA - Each36800-73757634d01-cc8c-4282-9e7c-2e9bc02bae5812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]3
MICONAZOLEACTIVE MOIETY7NNO0D7S5MTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]3
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]3
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]3
BRONOPOLINACTIVE INGREDIENT6PU1E16C9WTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]3
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]3
DISODIUM COCOAMPHODIACETATEINACTIVE INGREDIENT18L9G3U51MTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]3
GELATININACTIVE INGREDIENT2G86QN327LTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4TOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]3
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]3
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]3
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]3
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]3
PEG-5 OLEATEINACTIVE INGREDIENT0240V77G50TOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]3
PEG-75 LANOLININACTIVE INGREDIENT09179OX7TBTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]3
PEGOXOL 7 STEARATEINACTIVE INGREDIENT3EW5AXE5X5TOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]3
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RTOPCARE MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [TOPCO ASSOCIATES LLC]3

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FOSTER AND THRIVE MICONAZOLE 1MICONAZOLE NITRATEStrategic Sourcing Services LLC0d3fcb1a-54dd-49b7-b776-4366fc2147b32026-08-12WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
miconazole 1MICONAZOLE NITRATEKroger Company11878a63-93e7-464f-97fc-54899884d7fe2026-08-11WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
topcare miconazole 1MICONAZOLE NITRATETopco Associates LLC8138de63-c7e9-4b2c-a0e2-c62292a0b3202026-08-11WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
MICONAZOLE 1MICONAZOLE NITRATESafewaybd756451-6f63-4475-9d9a-7fef6a9e5ebf2026-08-03WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
equate miconazole 1MICONAZOLE NITRATEWal-Mart Stores Inc5c5b0486-9ec2-4e14-a35c-80da8e62c59e2026-07-06WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
miconazole 1MICONAZOLE NITRATEMeijer Distribution Incc34d9917-ee79-4afb-9338-6f18e63b2b092025-01-13WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
up and up miconazoleMICONAZOLE NITRATETarget Corporationb626313a-b8aa-43fe-b8a9-475009ea5b532024-12-11WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
miconazole 1 yeast infection reliefMICONAZOLE NITRATECVS Pharmacyb0e5320b-73d5-4e96-8ce4-9a858e9d2ed32024-12-10WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
Basic Care MiconazoleMICONAZOLE NITRATEAmazon.com Services LLC962bef75-1583-4782-bfba-52a68876eedc2024-11-04WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
careone miconazole 1MICONAZOLE NITRATEAmerican Sales Companyf51af8e2-fb06-4842-8021-b7efd515022e2023-10-23WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
exchange select miconazole 1MICONAZOLE NITRATEArmy & Air Force Exchange Service672d935f-0807-44d1-8faa-94d4169070952022-11-29WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
Signature Care Miconazole 1MICONAZOLE NITRATESafeway5129e042-421e-41e3-a0be-90f12d12b40b2022-11-15WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
miconazole 1MICONAZOLE NITRATEH E B40cc911b-2c35-4382-a979-fb1a165049db2022-11-12WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
Good Neighbor Pharmacy Miconazole 1MICONAZOLE NITRATEAmerisource Bergen12c400dc-4fbf-4a10-9a4d-5156d65b509a2022-11-09WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-737-45368000737451 KIT in 1 CARTON (36800-737-45) * 3 PACKAGE in 1 KIT > 1 SWAB in 1 PACKAGE * 1 TUBE in 1 KIT > 9 g in 1 TUBE * 1 BLISTER PACK in 1 KIT > 1 INSERT in 1 BLISTER PACK1 kit2010-06-150000-00-00NoNoCurrent