Home NDC 68788-9665 Clotrimazole
Product NDC 68788-9665
11-digit product format 687889665
Labeler code 68788
Product ID 68788-9665_61f64e2c-533a-4712-8c95-fb2fbf37c054
Type HUMAN OTC DRUG
Nonproprietary name Clotrimazole
Dosage form CREAM
Route VAGINAL
Labeler Preferred Pharmaceuticals, Inc.
Application ANDA072641
Marketing category ANDA
Marketing start 2013-08-05
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A072641-001 CLOTRIMAZOLE CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04
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 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 c2088c7a36db…2026-09-14 22:38:34 2026-08 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072641-001 CLOTRIMAZOLE 1% CREAM / VAGINAL 1995-12-04 3a93d1ddd44b…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Clotrimazole
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOTRIMAZOLE 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G07GZ97H65 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309368 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68788-9665-4 Clotrimazole 45 g in 1 TUBE CREAM 45 9 68788-9665-4 Clotrimazole 1 in 1 CARTON CREAM 1 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Clotrimazole ACTIVE INGREDIENT G07GZ97H65 CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 Clotrimazole ACTIVE MOIETY G07GZ97H65 CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 benzyl alcohol INACTIVE INGREDIENT LKG8494WBH CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 cetostearyl alcohol INACTIVE INGREDIENT 2DMT128M1S CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 cetyl esters wax INACTIVE INGREDIENT D072FFP9GU CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 octyldodecanol INACTIVE INGREDIENT 461N1O614Y CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 sorbitan monostearate INACTIVE INGREDIENT NVZ4I0H58X CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-9665 CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20250309_624827d6-dbf8-4f3d-a8c0-c92474cad7de.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68788-9665-4 68788966504 1 TUBE in 1 CARTON (68788-9665-4) / 45 g in 1 TUBE 1 tube 2013-08-05 0000-00-00 No No Current