FDA.reportPublic FDA data

Clotrimazole

Product NDC
50090-0614
Requested package NDC
50090-0614-0
11-digit product format
500900614
Labeler code
50090
Product ID
50090-0614_dac23c28-1694-4482-9fdb-492595e970e0
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
VAGINAL
Labeler
A-S Medication Solutions
Application
ANDA072641
Marketing category
ANDA
Marketing start
1995-12-04
Substance
CLOTRIMAZOLE
Active strength
1 g/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage50090-061450090-0614-0EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
A072641-001CLOTRIMAZOLECLOTRIMAZOLE1%CREAM / VAGINAL1995-12-04

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 UTC2026-02A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-043f01610625f2…
2019-09-15 20:21 UTC2019-09A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A072641-001CLOTRIMAZOLE1%CREAM / VAGINAL1995-12-04cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Clotrimazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G07GZ97H65Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309368Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bac80746-5cc3-4910-a0af-d43b8242acc6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0614-02023-02-07C16284748780-1f386c64a-446e-0266-e053-dadaa90a7c1aClotrimazole Vaginal Cream USP 1%
50090-0614-02023-01-30C16284748780-1f386c64a-446e-0266-e053-dadaa90a7c1aClotrimazole Vaginal Cream USP 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0614-0Clotrimazole1 in 1 CARTONCREAM114
50090-0614-0Clotrimazole45 g in 1 TUBECREAM4514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0614-0GM - Gram50090-0614c27a8898-36fb-4e77-b5f0-e80728fafe2212024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0614CLOTRIMAZOLE CREAM [A-S MEDICATION SOLUTIONS]12Current NDC, Legacy NDC, 2 package rows20230208_bac80746-5cc3-4910-a0af-d43b8242acc6.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
ClotrimazoleCLOTRIMAZOLEPreferred Pharmaceuticals, Inc.624827d6-dbf8-4f3d-a8c0-c92474cad7de2026-03-31WarningsExact identifier
application applno (ANDA): 072641
application number: ANDA072641
ClotrimazoleCLOTRIMAZOLEA-S Medication Solutionsbac80746-5cc3-4910-a0af-d43b8242acc62026-01-29WarningsExact identifier
application applno (ANDA): 072641
application number: ANDA072641
ndc (package): 50090-0614-0
ndc (product): 50090-0614
ndc11 (package): 50090061400
ClotrimazoleCLOTRIMAZOLESTRATEGIC SOURCING SERVICES LLC8c7cc657-28a1-4720-97ce-098207bfc4702025-07-21WarningsExact identifier
application applno (ANDA): 072641
application number: ANDA072641
ClotrimazoleCLOTRIMAZOLESun Pharmaceutical Industries, Inc.f7192955-8f8c-45dd-a215-8ac2c1f6444f2025-06-12WarningsExact identifier
application applno (ANDA): 072641
application number: ANDA072641
ClotrimazoleCLOTRIMAZOLENuCare Pharmaceuticals,Inc.ab0e14b8-8c64-435c-e053-2a95a90acfba2024-07-17WarningsExact identifier
application applno (ANDA): 072641
application number: ANDA072641

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309368clotrimazole 1 % Vaginal CreamPSNbac80746-5cc3-4910-a0af-d43b8242acc614
309368clotrimazole 10 MG/ML Vaginal CreamSCDbac80746-5cc3-4910-a0af-d43b8242acc614
309368clotrimazole 1 % Vaginal CreamSYbac80746-5cc3-4910-a0af-d43b8242acc614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0614-0500900614001 TUBE in 1 CARTON (50090-0614-0) / 45 g in 1 TUBE1 tube2014-11-280000-00-00NoNoCurrent