FDA.reportPublic FDA data

CLOTRIMAZOLE

Product NDC
0536-1443
11-digit product format
005361443
Labeler code
0536
Product ID
0536-1443_51921fa3-cebb-5959-e063-6294a90aaca2
Type
HUMAN OTC DRUG
Nonproprietary name
CLOTRIMAZOLE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Rugby Laboratories, Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-21
Substance
CLOTRIMAZOLE
Active strength
1 g/100mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLOTRIMAZOLECLOTRIMAZOLERugby Laboratories, Inc.2c60e631-5930-4420-886d-eb1990c720b62026-05-11WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only Ask a doctor before use on children under 2 years of age. When using this product avoid contact with eyes Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch) Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
CLOTRIMAZOLE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE1 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65
Rxcui309370

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
0536-1443-70CLOTRIMAZOLE1 in 1 CARTONSOLUTION14
0536-1443-70CLOTRIMAZOLE10 mL in 1 BOTTLESOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1443-70ML - Milliliter0536-1443962afd7d-9ee3-4c18-bb60-ffa6095c5ff512025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1443CLOTRIMAZOLE SOLUTION [RUGBY LABORATORIES, INC.]2Current NDC, 2 package rows20241129_2c60e631-5930-4420-886d-eb1990c720b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309370clotrimazole 1 % Topical SolutionPSN2c60e631-5930-4420-886d-eb1990c720b64
309370clotrimazole 10 MG/ML Topical SolutionSCD2c60e631-5930-4420-886d-eb1990c720b64
309370clotrimazole 1 % Topical SolutionSY2c60e631-5930-4420-886d-eb1990c720b64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0536-1443-70005361443701 BOTTLE in 1 CARTON (0536-1443-70) / 10 mL in 1 BOTTLE1 bottle2024-11-21NoNoCurrent