Clotrimazole

Product NDC
68788-0169
11-digit product format
687880169
Labeler code
68788
Product ID
68788-0169_68f02939-7202-4c7f-b4d3-ae44d682d678
Type
HUMAN OTC DRUG
Nonproprietary name
clotrimazole
Dosage form
CREAM
Route
VAGINAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA074165
Marketing category
ANDA
Marketing start
2013-08-06
Marketing end
0000-00-00
Substance
CLOTRIMAZOLE
Active strength
1 g/100g
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct68788-0169IInactivated by FDA2026-08-07
excluded packagepackage68788-016968788-0169-4IInactivated by FDA2026-08-07

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-0169-4IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-0169-4IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-0169-4IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-0169-4IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-0169-4IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-0169-4IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-0169-4IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-0169-4IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-0169-4IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-0169-4IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-0169-4IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-0169-4IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68788-0169-4IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68788-0169-4IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68788-0169-4IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68788-0169-4IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68788-0169-4IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68788-0169-4IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68788-0169-4IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68788-0169-4IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68788-0169-4IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage68788-0169-4EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
A074165-001CLOTRIMAZOLECLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-16

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 UTC2026-02A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-163f01610625f2…
2019-09-15 20:21 UTC2019-09A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074165-001CLOTRIMAZOLE1%CREAM / VAGINALRS1993-07-16cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-0169-42020-01-31C16284748780-19d75b9d0-5f56-f424-e053-dadaa90a57ceClotrimazole Vaginal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-0169-4Clotrimazole45 g in 1 TUBECREAM454
68788-0169-4Clotrimazole1 in 1 CARTONCREAM14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUCLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
OCTYLDODECYL STEARATEINACTIVE INGREDIENTK6F16QGO28CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNCLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XCLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-0169CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]4Legacy NDC, 2 package rows20170616_0e696120-8cc9-40f1-a03e-9c681b3790b2.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClotrimazoleCLOTRIMAZOLEWalgreens7ca79361-6608-4eda-ba5b-16c28eb6c0192026-06-09WarningsExact identifier
application applno (ANDA): 074165
application number: ANDA074165
ClotrimazoleCLOTRIMAZOLEPreferred Pharmaceuticals Inc.80d67df3-843d-47bb-85a2-d2f26a8243362026-03-31WarningsExact identifier
application applno (ANDA): 074165
application number: ANDA074165
ClotrimazoleCLOTRIMAZOLEPreferred Pharmaceuticals Inc.fd010006-f646-46ed-841a-9f247b19e3972026-03-31WarningsExact identifier
application applno (ANDA): 074165
application number: ANDA074165
ClotrimazoleCLOTRIMAZOLERite Aid Corporation384c8113-87aa-4fbd-942a-5f02c4e885362025-10-14WarningsExact identifier
application applno (ANDA): 074165
application number: ANDA074165
ClotrimazoleCLOTRIMAZOLEStrategic Sourcing Services LLCde3b6b64-dfa5-4abd-ba43-4ab59b4c22842025-09-09WarningsExact identifier
application applno (ANDA): 074165
application number: ANDA074165
ClotrimazoleCLOTRIMAZOLECardinal Health (Leader) 700004aaae616-179b-40f1-8a39-6a1ddd4140702025-04-29WarningsExact identifier
application applno (ANDA): 074165
application number: ANDA074165
ClotrimazoleCLOTRIMAZOLEA-S Medication Solutions6b908538-d9ff-41d0-909c-01e1d1b21a392024-10-23WarningsExact identifier
application applno (ANDA): 074165
application number: ANDA074165
ClotrimazoleCLOTRIMAZOLEQUALITY CHOICE (Chain Drug Marketing Association)3c676ff0-44a8-40cd-8f85-d39dda3d96372024-05-23WarningsExact identifier
application applno (ANDA): 074165
application number: ANDA074165
ClotrimazoleCLOTRIMAZOLEH2-Pharma, LLC388f7e35-efbe-496b-a8d6-518caa22328d2023-01-11WarningsExact identifier
application applno (ANDA): 074165
application number: ANDA074165

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309368clotrimazole 1 % Vaginal CreamPSN0e696120-8cc9-40f1-a03e-9c681b3790b24
309368clotrimazole 10 MG/ML Vaginal CreamSCD0e696120-8cc9-40f1-a03e-9c681b3790b24
309368clotrimazole 1 % Vaginal CreamSY0e696120-8cc9-40f1-a03e-9c681b3790b24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68788-0169-46878801690445 g in 1 TUBE45 gHistorical