signature care tioconazole 1

Product NDC
21130-060
11-digit product format
211300060
Labeler code
21130
Product ID
21130-060_a6c0d30b-1e93-4b4e-bd13-c480eab4aece
Type
HUMAN OTC DRUG
Nonproprietary name
Tioconazole
Dosage form
OINTMENT
Route
VAGINAL
Labeler
Safeway
Application
ANDA075915
Marketing category
ANDA
Marketing start
2015-09-24
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
signature care 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
21130-060-54signature care tioconazole 11 in 1 POUCHOINTMENT114
21130-060-54signature care tioconazole 11 in 1 CARTONOINTMENT114

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIOCONAZOLEACTIVE INGREDIENTS57Y5X1117SIGNATURE CARE TIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [SAFEWAY]1
TIOCONAZOLEACTIVE MOIETYS57Y5X1117SIGNATURE CARE TIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [SAFEWAY]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIGNATURE CARE TIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [SAFEWAY]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCSIGNATURE CARE TIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [SAFEWAY]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USIGNATURE CARE TIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [SAFEWAY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-060SIGNATURE CARE TIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [SAFEWAY]14Current NDC, Legacy NDC, 2 package rows20250327_22ac4774-87b4-437f-8520-e4a4ed6e1c55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198380tioconazole 6.5 % Vaginal OintmentPSN22ac4774-87b4-437f-8520-e4a4ed6e1c5514
198380tioconazole 0.065 MG/MG Vaginal OintmentSCD22ac4774-87b4-437f-8520-e4a4ed6e1c5514
198380tioconazole 6.5 % Vaginal OintmentSY22ac4774-87b4-437f-8520-e4a4ed6e1c5514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-060-54211300060541 POUCH in 1 CARTON (21130-060-54) / 1 TUBE, WITH APPLICATOR in 1 POUCH / 4.6 g in 1 TUBE, WITH APPLICATOR1 pouch2015-09-240000-00-00NoNoCurrent