FDA.reportPublic FDA data

CLOTIC (clotrimazole) otic solution

Product NDC
15370-220
11-digit product format
153700220
Labeler code
15370
Product ID
15370-220_5a7a78a3-12b4-43f9-9212-fc7db56ca3f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clotrimazole
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
Carwin Pharmaceutical Associates, LLC
Application
NDA217628
Marketing category
NDA
Marketing start
2026-02-19
Substance
CLOTRIMAZOLE
Active strength
1.7 mg/.17mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CLOTIC (clotrimazole) otic solution
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE1.7 mg/.17mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65
Rxcui2725165, 2725626

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15370-220-28CLOTIC (clotrimazole) otic solution2 in 1 CARTONLIQUID21
15370-220-28CLOTIC (clotrimazole) otic solution14 in 1 POUCHLIQUID141
15370-220-99CLOTIC (clotrimazole) otic solution1 in 1 CARTONLIQUID11
15370-220-99CLOTIC (clotrimazole) otic solution2 in 1 POUCHLIQUID21

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2725626Clotic 1 % Otic SolutionPSNef0658c3-9c6b-4705-89d8-cf0644c80fcb1
2725165clotrimazole 1 % Otic SolutionPSNef0658c3-9c6b-4705-89d8-cf0644c80fcb1
2725626clotrimazole 10 MG/ML Otic Solution [Clotic]SBDef0658c3-9c6b-4705-89d8-cf0644c80fcb1
2725165clotrimazole 10 MG/ML Otic SolutionSCDef0658c3-9c6b-4705-89d8-cf0644c80fcb1
2725626Clotic 1 % Otic SolutionSYef0658c3-9c6b-4705-89d8-cf0644c80fcb1
2725626Clotic 10 MG/ML Otic SolutionSYef0658c3-9c6b-4705-89d8-cf0644c80fcb1
2725165clotrimazole 1 % Otic SolutionSYef0658c3-9c6b-4705-89d8-cf0644c80fcb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
15370-220-28153700220282 POUCH in 1 CARTON (15370-220-28) / 14 VIAL, SINGLE-DOSE in 1 POUCH / .17 mL in 1 VIAL, SINGLE-DOSE2 pouch2026-02-19NoNoHistorical
15370-220-99153700220991 POUCH in 1 CARTON (15370-220-99) / 2 VIAL, SINGLE-DOSE in 1 POUCH / .17 mL in 1 VIAL, SINGLE-DOSE1 pouch2026-02-19YesNoHistorical