FDA.reportPublic FDA data

CAREALL Tolnaftate

Product NDC
51824-001
11-digit product format
518240001
Labeler code
51824
Product ID
51824-001_44ec1209-557e-ac0f-e063-6394a90a4274
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
CREAM
Route
TOPICAL
Labeler
New World Imports, Inc
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-06-01
Substance
TOLNAFTATE
Active strength
10 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CAREALL Tolnaftate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
06KB629TKVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
103951Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cabf84c1-1500-46fe-b226-b16d4a0666c7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51824-001-01CAREALL Tolnaftate28 g in 1 TUBECREAM2814
51824-001-05CAREALL Tolnaftate14 g in 1 TUBECREAM1414

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51824-001-01GM - Gram51824-001f647e118-dc13-4ba8-a36f-7a6c807c5bce12020-03-10
51824-001-05GM - Gram51824-00105105d17-2bba-49de-b472-eed92cad36c512020-03-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TolnaftateACTIVE INGREDIENT06KB629TKVCAREALL TOLNAFTATE (TOLNAFTATE) CREAM [NEW WORLD IMPORTS, INC]6
TolnaftateACTIVE MOIETY06KB629TKVCAREALL TOLNAFTATE (TOLNAFTATE) CREAM [NEW WORLD IMPORTS, INC]6
Ceteth-20INACTIVE INGREDIENTI835H2IHHXCAREALL TOLNAFTATE (TOLNAFTATE) CREAM [NEW WORLD IMPORTS, INC]6
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNCAREALL TOLNAFTATE (TOLNAFTATE) CREAM [NEW WORLD IMPORTS, INC]6
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TCAREALL TOLNAFTATE (TOLNAFTATE) CREAM [NEW WORLD IMPORTS, INC]6
Mineral OilINACTIVE INGREDIENTT5L8T28FGPCAREALL TOLNAFTATE (TOLNAFTATE) CREAM [NEW WORLD IMPORTS, INC]6
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3CAREALL TOLNAFTATE (TOLNAFTATE) CREAM [NEW WORLD IMPORTS, INC]6
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHCAREALL TOLNAFTATE (TOLNAFTATE) CREAM [NEW WORLD IMPORTS, INC]6
Sorbitan MonostearateINACTIVE INGREDIENTNVZ4I0H58XCAREALL TOLNAFTATE (TOLNAFTATE) CREAM [NEW WORLD IMPORTS, INC]6
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YCAREALL TOLNAFTATE (TOLNAFTATE) CREAM [NEW WORLD IMPORTS, INC]6
WaterINACTIVE INGREDIENT059QF0KO0RCAREALL TOLNAFTATE (TOLNAFTATE) CREAM [NEW WORLD IMPORTS, INC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51824-001CAREALL TOLNAFTATE (TOLNAFTATE) CREAM [NEW WORLD IMPORTS, INC]13Current NDC, Legacy NDC, 2 package rows20240119_cabf84c1-1500-46fe-b226-b16d4a0666c7.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 1 of 51 · 1,001 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WISH HAND SANITIZER Banana Cream SugarALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA5912d7e8-94a7-e8b9-e063-6394a90a74d62026-08-15WarningsExact identifier
application number: M005
WISH HAND SANITIZER Caramel Vanilla PopcornALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA591317be-856e-1374-e063-6394a90a7aaf2026-08-15WarningsExact identifier
application number: M005
BlissCare tea tree oil antifungalTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd58f9ff8c-d75a-ad1d-e063-6294a90af3dc2026-08-14WarningsExact identifier
application number: M005
WISH HAND SANITIZER Rose WoodsALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA58fb4491-2918-c486-e063-6394a90a621f2026-08-14WarningsExact identifier
application number: M005
VXGXO antifungal with tea tree oilTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd58fd67c5-c985-13a7-e063-6294a90a40fb2026-08-14WarningsExact identifier
application number: M005
Charmpoo ANTIFUNGAL BODY CreamMICONAZOLE NITRATE 2% ANTIFUNGAL BODY CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.58ff4779-83a7-afe2-e063-6294a90a9f9a2026-08-14WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEYYBA CORP58f1707a-579b-1e06-e063-6294a90a5a9f2026-08-13WarningsExact identifier
application number: M005
WISH HAND SANITIZER Mango Coconut CreamALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA58faa781-520b-92fa-e063-6294a90a9ecf2026-08-13WarningsExact identifier
application number: M005
Gemachlich Zu Hause Vaginal Antifungal GelMICONAZOLE NITRATEGuangzhou Xinhongda Trading Service Co., Ltd.563cfb57-f10c-96a6-e063-6294a90a2b932026-08-12WarningsExact identifier
application number: M005
Hecila ANTIFUNGAL NAILUNDECYLENIC ACID 25% ANTIFUNGAL NAILWenzhou Yuyuan Pharmaceutical Co., Ltd.58c117cc-e039-86f6-e063-6394a90af18f2026-08-12WarningsExact identifier
application number: M005
TOTCLEAR NAIL RENEWALUNDECYLENIC ACIDGOOD BRIDGE LLC93605e22-920d-43c3-bb2b-6e3116a19f5e2026-08-12WarningsExact identifier
application number: M005
TOTCLEAR NAIL RENEWALUNDECYLENIC ACIDGOOD BRIDGE LLCfde7d6ea-1b44-4a88-820a-0f2e033727e12026-08-11WarningsExact identifier
application number: M005
XBOFPEN MULTI-PURPOSE TREATMENTTOLNAFTATE 1% MULTI-PURPOSE TREATMENTWenzhou Yuyuan Pharmaceutical Co., Ltd.58c2f50c-9c9e-4989-e063-6394a90abb212026-08-11WarningsExact identifier
application number: M005
QualiLife persimmon foot and shoeUNDECYLENIC ACIDGuangdong Aimu Biological Technology Co., Ltd584966c7-ceae-91af-e063-6294a90ac1eb2026-08-10WarningsExact identifier
application number: M005
Aiilo WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.58ad9307-a9f9-4de8-e063-6394a90adaa62026-08-10WarningsExact identifier
application number: M005
Aiilo WART REMOVER PATCHESSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.58af5ac2-75a7-246d-e063-6394a90ae9662026-08-10WarningsExact identifier
application number: M005
Persiancat ANTIFUNGAL PENUNDECYLENIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.58affb96-6cfc-b1fb-e063-6294a90a340c2026-08-10WarningsExact identifier
application number: M005
Dryello Tolnaftate 1% AntifungalTOLNAFTATEProPedix, Inc.58b6820c-f601-5921-e063-6294a90aa5e92026-08-10WarningsExact identifier
application number: M005
Anti-fungalANTI-FUNGAL SOAPShenzhen Chaoxiji Technology Co.,Ltd.586ce6bf-2915-8ae7-e063-6394a90ae9be2026-08-06WarningsExact identifier
application number: M005
Anti-fungalANTI-FUNGAL SOAPShenzhen Chaoxiji Technology Co.,Ltd.586d92cb-4944-0e7b-e063-6394a90a37a22026-08-06WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103951tolnaftate 1 % Topical CreamPSNcabf84c1-1500-46fe-b226-b16d4a0666c714
103951tolnaftate 10 MG/ML Topical CreamSCDcabf84c1-1500-46fe-b226-b16d4a0666c714
103951tolnaftate 1 % Topical CreamSYcabf84c1-1500-46fe-b226-b16d4a0666c714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51824-001-015182400010128 g in 1 TUBE (51824-001-01) 28 g2018-06-150000-00-00NoNoCurrent
51824-001-055182400010514 g in 1 TUBE (51824-001-05) 14 g2012-06-010000-00-00NoNoCurrent