dg health tioconazole 1

Product NDC
55910-731
11-digit product format
559100731
Labeler code
55910
Product ID
55910-731_76043021-1ced-40da-8b62-fa2de5c2839d
Type
HUMAN OTC DRUG
Nonproprietary name
Tioconazole
Dosage form
OINTMENT
Route
VAGINAL
Labeler
Dolgencorp, LLC
Application
ANDA075915
Marketing category
ANDA
Marketing start
2019-03-01
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
dg health 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
55910-731-54dg health tioconazole 11 in 1 POUCHOINTMENT12
55910-731-54dg health tioconazole 11 in 1 CARTONOINTMENT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-731DG HEALTH TIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [DOLGENCORP, LLC]2Current NDC, Legacy NDC, 2 package rows20210526_39bada3c-510e-47ae-a125-30e41e483382.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198380tioconazole 6.5 % Vaginal OintmentPSN39bada3c-510e-47ae-a125-30e41e4833822
198380tioconazole 0.065 MG/MG Vaginal OintmentSCD39bada3c-510e-47ae-a125-30e41e4833822
198380tioconazole 6.5 % Vaginal OintmentSY39bada3c-510e-47ae-a125-30e41e4833822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-731-54559100731541 POUCH in 1 CARTON (55910-731-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR1 pouch2019-03-010000-00-00NoNoCurrent