ClotrimazOil Antifungal

Product NDC
68927-3490
11-digit product format
689273490
Labeler code
68927
Product ID
68927-3490_c0a7230b-949a-2f80-e053-2a95a90a4c89
Type
HUMAN OTC DRUG
Nonproprietary name
CLOTRIMAZOLE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Pedifix, Inc.
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-06-19
Marketing end
0000-00-00
Substance
CLOTRIMAZOLE
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68927-3490-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68927-3490-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68927-3490-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68927-3490-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68927-3490-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68927-3490-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68927-3490-10efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.]1
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65CLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0CLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.]1
ALMOND OILINACTIVE INGREDIENT66YXD4DKO9CLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KCLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.]1
EMU OILINACTIVE INGREDIENT344821WD61CLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.]1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662CLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.]1
JOJOBA OILINACTIVE INGREDIENT724GKU717MCLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.]1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8CLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.]1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1ECLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.]1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHCLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.]1
SAFFLOWER OILINACTIVE INGREDIENT65UEH262ISCLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.]1
SOYBEAN OILINACTIVE INGREDIENT241ATL177ACLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.]1
UREAINACTIVE INGREDIENT8W8T17847WCLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68927-3490-1689273490011 BOTTLE in 1 CARTON (68927-3490-1) > 15 mL in 1 BOTTLE1 bottle2017-02-070000-00-00NoNoCurrent