FDA.reportPublic FDA data

CAREALL Clotrimazole

Product NDC
51824-063
11-digit product format
518240063
Labeler code
51824
Product ID
51824-063_1b131084-a996-4923-9a06-f6f19072ade2
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
New World Imports, Inc
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-03-21
Marketing end
2027-04-01
Substance
CLOTRIMAZOLE
Active strength
10 g/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
CAREALL Clotrimazole

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE10 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G07GZ97H65Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ebc565bb-e56c-43ba-a5cb-d2fad2aafc4aAvailable on FDA.report

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
51824-063-01CAREALL Clotrimazole28 g in 1 TUBECream2810

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51824-063-01GM - Gram51824-0633accd27b-48a9-4928-ab2f-69b43fc4dbe212020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51824-063CAREALL CLOTRIMAZOLE (CLOTRIMAZOLE) CREAM [NEW WORLD IMPORTS, INC]10Current NDC, Legacy NDC, 1 package rows20241009_ebc565bb-e56c-43ba-a5cb-d2fad2aafc4a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 44 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BLUESEA INSTANT HAND SANITIZERALCOHOLBLUE SEA AEROSOL & DAILY CARE CO., LTDe6b5ce49-d6d6-4b24-8b40-bfb1fb7005bd2024-12-06WarningsExact identifier
application number: M005
Povidone-IodinePOVIDONE-IODINEMazza Healthcare, LLC31df570a-35ae-41a2-b04a-fce65e9d596d2024-11-21WarningsExact identifier
application number: M005
Povidone-IodinePOVIDONE-IODINEMazza Healthcare, LLC3dc3303f-54b2-4aec-8568-5e0f8eb7cb142024-11-21WarningsExact identifier
application number: M005
WINCO ANTIFUNGALTOLNAFTATE 1%WinCo Foods LLC46b58c71-d62e-4b3d-b2ec-65407032eeea2024-11-21WarningsExact identifier
application number: M005
Dynarex AntifungalANTIFUNGALDynarex Corporationab5b6467-c158-4407-9d52-3c07310306802024-11-20WarningsExact identifier
application number: M005
Terrasil JockItch Treatment Maximum StrengthCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions8afe11c1-0a85-4255-8eba-e8cbde0759a02024-11-20WarningsExact identifier
application number: M005
Terrasil Ringworm Treatment MAXCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsfc2b740a-49c1-4a01-a94c-8cade52a2b822024-11-20WarningsExact identifier
application number: M005
MICONAZOLE NITRATEMICONAZOLE NITRATEALLIED TRADE LINK LLC25520dba-0159-2a3f-e063-6294a90a4c332024-11-12WarningsExact identifier
application number: M005
CLOTRIMAZOLECLOTRIMAZOLEALLIED TRADE LINK LLC266d7b94-2954-4831-e063-6394a90a3f332024-11-08WarningsExact identifier
application number: M005
AntifungalTOLNAFTATE 1%Chain Drug Marketing Association Inc.26303499-dc58-f417-e063-6394a90a0a1b2024-11-05WarningsExact identifier
application number: M005
AZOLENMICONAZOLE NITRATESTRATUS PHARMACEUTICALS INC3264bd0a-c628-404b-8c09-8586682d054e2024-10-31WarningsExact identifier
application number: M005
BACITRACIN ZINCBACITRACIN ZINCSTRATUS PHARMACEUTICALS INCb2cb3a96-b0ca-42ee-8056-91d5450fb3762024-10-31WarningsExact identifier
application number: M005
Premier Value Antifungal Maximum StrengthUNDECYLENIC ACIDPHARMACY VALUE ALLIANCE, LLCf5694ee5-616c-40f6-8da4-c3620dbcd6f72024-10-28WarningsExact identifier
application number: M005
Clotrimazole 1%CLOTRIMAZOLEChain Drug Marketing Association Inc.24ff5ad7-2ff9-b254-e063-6394a90a27a72024-10-21WarningsExact identifier
application number: M005
Micomitin AntifungalTOLNAFTATEPureTek Corporationde9842ba-0254-8ae1-e053-2995a90a06642024-10-16WarningsExact identifier
application number: M005
Ongo - FinTOLNAFTATEEfficient Laboratories Inc.bb5fb71f-bee0-42fa-9c9f-6231b555324c2024-10-14WarningsExact identifier
application number: M005
Hongo KillerUNDECYLENIC ACIDEfficient Laboratories Inc5c433182-0c0c-4a0a-8dd8-a14f60e524252024-10-14WarningsExact identifier
application number: M005
Miconazole nitrateANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAYMeijer Distribution Inc6c2ebe17-994d-41c8-bacb-87b6a63b2db42024-10-14WarningsExact identifier
application number: M005
Miconazole NitrateANTIFUNGALMcKesson8dcca44a-16c7-7262-e053-2a95a90a1b232024-10-10WarningsExact identifier
application number: M005
CAREALL ClotrimazoleCLOTRIMAZOLENew World Imports, Incebc565bb-e56c-43ba-a5cb-d2fad2aafc4a2024-10-07WarningsExact identifier
application number: M005
ndc (product): 51824-063

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51824-063-015182400630128 g in 1 TUBE (51824-063-01) 28 g2016-03-212027-04-01NoNoCurrent