CareOne Tioconazole 1

Product NDC
41520-426
11-digit product format
415200426
Labeler code
41520
Product ID
41520-426_765f1ed8-68e3-4902-b0db-4959632dcdd6
Type
HUMAN OTC DRUG
Nonproprietary name
Tioconazole
Dosage form
OINTMENT
Route
VAGINAL
Labeler
American Sales Company
Application
ANDA075915
Marketing category
ANDA
Marketing start
2008-01-07
Substance
TIOCONAZOLE
Active strength
6.5 g/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CareOne Tioconazole 1
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIOCONAZOLE6.5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS57Y5X1117
Rxcui198380

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-426-54CareOne Tioconazole 11 in 1 CARTONOINTMENT14
41520-426-54CareOne Tioconazole 11 in 1 POUCHOINTMENT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-426CAREONE TIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [AMERICAN SALES COMPANY]4Current NDC, Legacy NDC, 2 package rows20241220_78139c20-6258-4da6-abd3-9ba5e5899fd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198380tioconazole 6.5 % Vaginal OintmentPSN78139c20-6258-4da6-abd3-9ba5e5899fd94
198380tioconazole 0.065 MG/MG Vaginal OintmentSCD78139c20-6258-4da6-abd3-9ba5e5899fd94
198380tioconazole 6.5 % Vaginal OintmentSY78139c20-6258-4da6-abd3-9ba5e5899fd94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-426-54415200426541 POUCH in 1 CARTON (41520-426-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR1 pouch2008-01-070000-00-00NoNoCurrent