FDA.reportPublic FDA data

clotrimazole

Product NDC
45802-434
11-digit product format
458020434
Labeler code
45802
Product ID
45802-434_467f8f2f-09b1-4701-b796-57a10576f7ca
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-06-03
Marketing end
2027-04-30
Substance
CLOTRIMAZOLE
Active strength
1 g/100g
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
CLOTRIMAZOLE1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65
Rxcui309367

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
45802-434-01clotrimazole15 g in 1 TUBECREAM158
45802-434-01clotrimazole1 in 1 CARTONCREAM18
45802-434-11clotrimazole1 in 1 CARTONCREAM18
45802-434-11clotrimazole28 g in 1 TUBECREAM288

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-434-01GM - Gram45802-434d14ca4ba-e10d-4e66-9753-635847aed1a612012-07-24
45802-434-11GM - Gram45802-434a0b1e4f4-5f17-41be-ab4f-f972953bca2e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]3
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]3
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]3
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUCLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]3
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YCLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]3
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]3
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XCLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]3
WATERINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]3
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUCLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YCLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XCLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-434CLOTRIMAZOLE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]7Current NDC, Legacy NDC, 4 package rows20240910_3dcd0158-ec51-4fa7-a26a-02c2926156c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSNc0f58a0d-a304-41f9-bbdf-c2e488230cf014
309367clotrimazole 10 MG/ML Topical CreamSCDc0f58a0d-a304-41f9-bbdf-c2e488230cf014
309367clotrimazole 1 % Topical CreamSYc0f58a0d-a304-41f9-bbdf-c2e488230cf014
309367clotrimazole 1 % Topical CreamPSNb63a3fe5-5684-41bc-ad6c-69c54e5b942d10
309367clotrimazole 10 MG/ML Topical CreamSCDb63a3fe5-5684-41bc-ad6c-69c54e5b942d10
309367clotrimazole 1 % Topical CreamSYb63a3fe5-5684-41bc-ad6c-69c54e5b942d10
309367clotrimazole 1 % Topical CreamPSN3dcd0158-ec51-4fa7-a26a-02c2926156c08
309367clotrimazole 10 MG/ML Topical CreamSCD3dcd0158-ec51-4fa7-a26a-02c2926156c08
309367clotrimazole 1 % Topical CreamSY3dcd0158-ec51-4fa7-a26a-02c2926156c08
309367clotrimazole 1 % Topical CreamPSNeeb241a3-93ee-4b74-8cbb-65713d15e7e07
309367clotrimazole 10 MG/ML Topical CreamSCDeeb241a3-93ee-4b74-8cbb-65713d15e7e07
309367clotrimazole 1 % Topical CreamSYeeb241a3-93ee-4b74-8cbb-65713d15e7e07
309367clotrimazole 1 % Topical CreamPSN627375fb-2f20-16bc-e053-2a91aa0a15425
309367clotrimazole 10 MG/ML Topical CreamSCD627375fb-2f20-16bc-e053-2a91aa0a15425
309367clotrimazole 1 % Topical CreamSY627375fb-2f20-16bc-e053-2a91aa0a15425
309367clotrimazole 1 % Topical CreamPSN54241254-1d9a-346a-e054-00144ff8d46c4
309367clotrimazole 10 MG/ML Topical CreamSCD54241254-1d9a-346a-e054-00144ff8d46c4
309367clotrimazole 1 % Topical CreamSY54241254-1d9a-346a-e054-00144ff8d46c4
309367clotrimazole 1 % Topical CreamPSN706f3bb5-1ada-420a-9d8e-79aea018df531
309368clotrimazole 1 % Vaginal CreamPSNef0b0fca-40c4-4bb6-8a0a-9c3ff717866f1
309367clotrimazole 10 MG/ML Topical CreamSCD706f3bb5-1ada-420a-9d8e-79aea018df531
309368clotrimazole 10 MG/ML Vaginal CreamSCDef0b0fca-40c4-4bb6-8a0a-9c3ff717866f1
309367clotrimazole 1 % Topical CreamSY706f3bb5-1ada-420a-9d8e-79aea018df531
309368clotrimazole 1 % Vaginal CreamSYef0b0fca-40c4-4bb6-8a0a-9c3ff717866f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-434-01458020434011 TUBE in 1 CARTON (45802-434-01) > 15 g in 1 TUBE1 tube2011-06-030000-00-00NoNoCurrent
45802-434-11458020434111 TUBE in 1 CARTON (45802-434-11) / 28 g in 1 TUBE1 tube2011-06-092027-04-30NoNoCurrent