Clotrimazole

Product NDC
11822-0220
11-digit product format
118220220
Labeler code
11822
Product ID
11822-0220_246843bf-e87e-49d3-9aed-a769b9baa782
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
VAGINAL
Labeler
Rite Aid Corporation
Application
ANDA074165
Marketing category
ANDA
Marketing start
1996-11-22
Marketing end
2027-01-01
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clotrimazole

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65
Rxcui309368

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0220-6Clotrimazole45 g in 1 TUBECREAM4510
11822-0220-6Clotrimazole1 in 1 CARTONCREAM110

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE 7 (CLOTRIMAZOLE) CREAM [RITE AID]1
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE 7 (CLOTRIMAZOLE) CREAM [RITE AID]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE 7 (CLOTRIMAZOLE) CREAM [RITE AID]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE 7 (CLOTRIMAZOLE) CREAM [RITE AID]1
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUCLOTRIMAZOLE 7 (CLOTRIMAZOLE) CREAM [RITE AID]1
OCTYLDODECYL STEARATEINACTIVE INGREDIENTK6F16QGO28CLOTRIMAZOLE 7 (CLOTRIMAZOLE) CREAM [RITE AID]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCLOTRIMAZOLE 7 (CLOTRIMAZOLE) CREAM [RITE AID]1
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNCLOTRIMAZOLE 7 (CLOTRIMAZOLE) CREAM [RITE AID]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XCLOTRIMAZOLE 7 (CLOTRIMAZOLE) CREAM [RITE AID]1
WATERINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE 7 (CLOTRIMAZOLE) CREAM [RITE AID]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0220CLOTRIMAZOLE CREAM [RITE AID CORPORATION]9Current NDC, Legacy NDC, 2 package rows20240927_384c8113-87aa-4fbd-942a-5f02c4e88536.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309368clotrimazole 1 % Vaginal CreamPSN384c8113-87aa-4fbd-942a-5f02c4e8853610
309368clotrimazole 10 MG/ML Vaginal CreamSCD384c8113-87aa-4fbd-942a-5f02c4e8853610
309368clotrimazole 1 % Vaginal CreamSY384c8113-87aa-4fbd-942a-5f02c4e8853610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0220-6118220220061 TUBE in 1 CARTON (11822-0220-6) / 45 g in 1 TUBE1 tube1996-11-222027-01-01NoNoCurrent