GOOD SENSE MICONAZOLE 3

Product NDC
0113-7110
11-digit product format
001137110
Labeler code
0113
Product ID
0113-7110_906dcf48-63d8-44cf-a699-d1f30c84a029
Type
HUMAN OTC DRUG
Nonproprietary name
miconazole nitrate
Dosage form
CREAM
Route
VAGINAL
Labeler
L. Perrigo Company
Application
ANDA091366
Marketing category
ANDA
Marketing start
2025-08-21
Substance
MICONAZOLE NITRATE
Active strength
40 mg/g
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
GOOD SENSE MICONAZOLE 3
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE40 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998544, 2288429

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-7110-14GOOD SENSE MICONAZOLE 31 in 1 POUCHCREAM11
0113-7110-14GOOD SENSE MICONAZOLE 33 in 1 CARTONCREAM31

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2288429{3 (5000 MG) (miconazole nitrate 40 MG/ML Vaginal Cream) } PackGPCK906dcf48-63d8-44cf-a699-d1f30c84a0291
2288429miconazole 4 % Vaginal Cream 3-Day Applicator PackPSN906dcf48-63d8-44cf-a699-d1f30c84a0291
998544miconazole nitrate 4 % Vaginal CreamPSN906dcf48-63d8-44cf-a699-d1f30c84a0291
998544miconazole nitrate 40 MG/ML Vaginal CreamSCD906dcf48-63d8-44cf-a699-d1f30c84a0291
2288429miconazole 4 % 3-Day Prefilled Applicator PackSY906dcf48-63d8-44cf-a699-d1f30c84a0291
998544miconazole nitrate 4 % Vaginal CreamSY906dcf48-63d8-44cf-a699-d1f30c84a0291

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0113-7110-14001137110143 POUCH in 1 CARTON (0113-7110-14) / 1 APPLICATOR in 1 POUCH / 5 g in 1 APPLICATOR3 pouch2025-08-21NoNoCurrent