Home NDC 68927-3490-1 ClotrimazOil Antifungal
Product NDC 68927-3490
Requested package NDC 68927-3490-1
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 · 7 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLOTRIMAZOLE ACTIVE INGREDIENT G07GZ97H65 CLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.] 1 CLOTRIMAZOLE ACTIVE MOIETY G07GZ97H65 CLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 CLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.] 1 ALMOND OIL INACTIVE INGREDIENT 66YXD4DKO9 CLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.] 1 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K CLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.] 1 EMU OIL INACTIVE INGREDIENT 344821WD61 CLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.] 1 EUCALYPTUS OIL INACTIVE INGREDIENT 2R04ONI662 CLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.] 1 JOJOBA OIL INACTIVE INGREDIENT 724GKU717M CLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.] 1 LAVENDER OIL INACTIVE INGREDIENT ZBP1YXW0H8 CLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.] 1 OLIVE OIL INACTIVE INGREDIENT 6UYK2W1W1E CLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.] 1 PEPPERMINT OIL INACTIVE INGREDIENT AV092KU4JH CLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.] 1 SAFFLOWER OIL INACTIVE INGREDIENT 65UEH262IS CLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.] 1 SOYBEAN OIL INACTIVE INGREDIENT 241ATL177A CLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.] 1 UREA INACTIVE INGREDIENT 8W8T17847W CLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CLOTRIMAZOIL ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [PEDIFIX, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68927-3490-1 68927349001 1 BOTTLE in 1 CARTON (68927-3490-1) > 15 mL in 1 BOTTLE 1 bottle 2017-02-07 0000-00-00 No No Current