care one miconazole 7

Product NDC
41520-214
11-digit product format
415200214
Labeler code
41520
Product ID
41520-214_252ce473-fd1a-4e78-bd73-0306e7ce229f
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
American Sales Company
Application
ANDA074760
Marketing category
ANDA
Marketing start
1999-10-11
Marketing end
2021-03-01
Substance
MICONAZOLE NITRATE
Active strength
2 g/100g
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct41520-214DDiscontinued by firm2026-08-07
excluded packagepackage41520-21441520-214-29DDiscontinued by firm2026-08-07

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 packagepackage41520-214-29d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41520-214-29f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage41520-214-292ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage41520-214-29a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage41520-214-29cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage41520-214-29cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage41520-214-29302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage41520-214-29ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage41520-214-290efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage41520-214-29ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage41520-214-29367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage41520-214-29557ba5c1ecfa…9c80585c8c6e…

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
A074760-001MICONAZOLE NITRATEMICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-15

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 UTC2026-02A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-153f01610625f2…
2019-09-15 20:21 UTC2019-09A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074760-001MICONAZOLE NITRATE2%CREAM / VAGINAL1997-05-15cb3db0bc1861…

DailyMed Socrata Ingredients#

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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense miconazole 7MICONAZOLE NITRATEPreferred Pharmaceuticals Inc.9e0af5f8-249e-434a-a9c6-eb2f4045d9f62026-06-08WarningsExact identifier
application applno (ANDA): 074760
application number: ANDA074760
miconazole 7MICONAZOLE NITRATEHyVee Inc53b9bcb3-ff43-4849-9f72-84febe2553282026-06-04WarningsExact identifier
application applno (ANDA): 074760
application number: ANDA074760
MICONAZOLE 7MICONAZOLE NITRATESafeway2f19d76f-1348-483e-8720-612d30928bb52026-05-26WarningsExact identifier
application applno (ANDA): 074760
application number: ANDA074760
Miconazole 7MICONAZOLE NITRATEMeijer Distribution Incb8417956-4c53-444e-823a-a87748eb0a082026-05-05WarningsExact identifier
application applno (ANDA): 074760
application number: ANDA074760
up and up miconazole 7MICONAZOLE NITRATETarget Corporationb6216f21-4af8-40ab-8151-a9367a42b82c2025-07-17WarningsExact identifier
application applno (ANDA): 074760
application number: ANDA074760
vagisil brand vagistatMICONAZOLE NITRATECombe Incorporated833a5e4d-0591-4300-8f9c-fd00ffaf60412025-04-15WarningsExact identifier
application applno (ANDA): 074760
application number: ANDA074760
miconazole 7MICONAZOLE NITRATEH E B9741b8c0-716a-4c54-9793-387866faf7662023-11-13WarningsExact identifier
application applno (ANDA): 074760
application number: ANDA074760
foster and thrive miconazole 7MICONAZOLE NITRATEStrategic Sourcing Services LLCb06590b5-1dcf-47b7-8e81-5887b1c3893a2023-11-05WarningsExact identifier
application applno (ANDA): 074760
application number: ANDA074760
foster and thrive miconazoleMICONAZOLE NITRATEStrategic Sourcing Services LLC09c4f6c9-ba51-47f4-95b4-d236fa45778b2023-10-25WarningsExact identifier
application applno (ANDA): 074760
application number: ANDA074760
Miconazole 7MICONAZOLE NITRATEKroger Company9fc3df65-c441-44ab-aaac-f63b565ca2f52023-09-13WarningsExact identifier
application applno (ANDA): 074760
application number: ANDA074760
Equaline Miconazole 7MICONAZOLE NITRATEUnited Natural Foods, Inc. dba UNFI7ebd51d9-8578-48c8-804a-e80fbe514fa12023-08-02WarningsExact identifier
application applno (ANDA): 074760
application number: ANDA074760
Basic Care Miconazole 7MICONAZOLE NITRATEAmazon.com Services LLC4a828083-f5a9-46c3-a07a-3d151f1550252021-08-13WarningsExact identifier
application applno (ANDA): 074760
application number: ANDA074760
DG Health MiconazoleMICONAZOLE NITRATEDolgencorp, LLC12a36975-ebfe-4fcb-a9de-981a213256322021-06-09WarningsExact identifier
application applno (ANDA): 074760
application number: ANDA074760
Topcare Miconazole 7MICONAZOLE NITRATETopco Associates LLC351905b1-f78c-4838-a036-23b2bfc775f22021-02-08WarningsExact identifier
application applno (ANDA): 074760
application number: ANDA074760
signature care miconazole 7MICONAZOLE NITRATESafeway2e04ac2d-cfbc-4261-a8f9-03715f819c1c2021-02-08WarningsExact identifier
application applno (ANDA): 074760
application number: ANDA074760
Good Neighbor Pharmacy Miconazole 7MICONAZOLE NITRATEAmerisource Bergen5a3441e8-f4fc-404f-8e9e-6d2aee2b8cec2021-01-27WarningsExact identifier
application applno (ANDA): 074760
application number: ANDA074760
Good Sense Miconazole 7MICONAZOLE NITRATEL Perrigo Company4902029e-47dd-483b-af03-b1b5936e98ea2021-01-27WarningsExact identifier
application applno (ANDA): 074760
application number: ANDA074760
good sense miconazole 7MICONAZOLE NITRATEL. Perrigo Company090ee644-7f73-4a43-aa5e-bfa74b0d51302021-01-06WarningsExact identifier
application applno (ANDA): 074760
application number: ANDA074760
Careone miconazole 7MICONAZOLE NITRATEAmerican Sales Companyfced0f7f-31b8-4975-836e-3f38c496a4502021-01-06WarningsExact identifier
application applno (ANDA): 074760
application number: ANDA074760

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41520-214-29415200214291 TUBE, WITH APPLICATOR in 1 CARTON (41520-214-29) > 45 g in 1 TUBE, WITH APPLICATOR2004-07-272021-03-01NoNoCurrent