Family Care Antifungal

Product NDC
65923-021
11-digit product format
659230021
Labeler code
65923
Product ID
65923-021_42532b7f-3807-eb5c-e063-6394a90af9d4
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
CREAM
Route
TOPICAL
Labeler
United Exchange Corp.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-01-02
Substance
TOLNAFTATE
Active strength
10 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Family Care Antifungal
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
6301ab99-1757-144a-e053-2a91aa0adb77Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-021-28Family Care Antifungal28 g in 1 TUBECREAM287
65923-021-28Family Care Antifungal1 in 1 CARTONCREAM17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65923-021FAMILY CARE ANTIFUNGAL (TOLNAFTATE) CREAM [UNITED EXCHANGE CORP.]6Current NDC, Legacy NDC, 2 package rows20241222_6301ab99-1757-144a-e053-2a91aa0adb77.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 13 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medi-First Clotrimazole 1% ANTIFUNGAL CreamCLOTRIMAZOLEUnifirst First Aid Corporation522eeb91-8378-32f4-e063-6394a90aff432026-05-20WarningsExact identifier
application number: M005
Kopa Haiku Antifungal CreamMICONAZOLE NITRATE 2%Trovina Co. Ltd47cf1251-5965-045a-e063-6394a90ab04f2026-05-19WarningsExact identifier
application number: M005
APUREE PRO Nailtific Maximum Strength Antifungal PatchesAPUREE PRO NAILTIFIC MAXIMUM STRENGTH ANTIFUNGAL PATCHESGuangzhou Meixi Biotechnology Co., Ltd.5218bd5d-53b4-107f-e063-6394a90ae7692026-05-18Exact identifier
application number: M005
APUREE Pro Nailtific Maximum Strength Dual-Action Antifungal PenAPUREE PRO NAILTIFIC MAXIMUM STRENGTH DUAL-ACTION ANTIFUNGAL PENGuangzhou Meixi Biotechnology Co., Ltd.521a0e40-a218-fabb-e063-6294a90ae9a22026-05-18WarningsExact identifier
application number: M005
Beukow Antifungal PenUNDECYLENIC ACID 25% ANTIFUNGAL PENJiangxi Yudexi Pharmaceutical Co., LTD511d1edf-dfda-477c-e063-6294a90aa4232026-05-17WarningsExact identifier
application number: M005
Nail Repair PenNAIL REPAIR PENShenzhen Earth Surface Trading Co., Ltd.520f6514-6660-d6a8-e063-6394a90adf822026-05-17WarningsExact identifier
application number: M005
Fungicure IntensiveCLOTRIMAZOLEKobayashi Healthcare International, Inc.1f1b413f-278e-434f-8590-4cf731663f5c2026-05-15WarningsExact identifier
application number: M005
Dr Scholls Fungal Nail Clear and Cure Tolnaftate AntifungalTOLNAFTATEScholl's Wellness Company LLC8abd6d8e-c69e-4374-ace8-d42b2d3e171e2026-05-14WarningsExact identifier
application number: M005
Dr.Scholl s Odor X Athlete s FootTOLNAFTATEScholl's Wellness Company LLC0e864882-5e00-491e-a008-0762c131637a2026-05-14WarningsExact identifier
application number: M005
Athletes FootTOLNAFTATERugby Laboratories50c46cf5-3e64-9e0f-e063-6294a90a23172026-05-14WarningsExact identifier
application number: M005
TOSSOYA Rainforest SecretGuard Antibacterial Quick-Cleanse WipesTOSSOYA RAINFOREST SECRETGUARD ANTIBACTERIAL QUICK-CLEANSE WIPESShenzhen Shierjie Biological Engineering Co., LTD3d53463d-8d8e-9030-e063-6294a90ab4542026-05-13WarningsExact identifier
application number: M005
Anti-Fungal PowderMICONAZOLE NITRATECVS Pharmacy1651bdd7-ab15-7a2d-e063-6294a90a8b912026-05-11WarningsExact identifier
application number: M005
Lightning X Hand CleanserETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.51861f1e-8961-e876-e063-6394a90a2fd02026-05-11WarningsExact identifier
application number: M005
APUREE Nailtific Maximum Strength Antifungal Patches PROAPUREE NAILTIFIC MAXIMUM STRENGTH ANTIFUNGAL PATCHES PROGuangzhou Meixi Biotechnology Co., Ltd5189ebc5-8ee5-1b2c-e063-6294a90af5c82026-05-11WarningsExact identifier
application number: M005
APUREE Nailtific Maximum Strength Dual-Action Antifungal Pen ProAPUREE NAILTIFIC MAXIMUM STRENGTH DUAL-ACTION ANTIFUNGAL PEN PROGuangzhou Meixi Biotechnology Co., Ltd.518abf2b-6ac8-ab9b-e063-6294a90ae6932026-05-11WarningsExact identifier
application number: M005
CLOTRIMAZOLECLOTRIMAZOLERugby Laboratories, Inc.2c60e631-5930-4420-886d-eb1990c720b62026-05-11WarningsExact identifier
application number: M005
TolfyraTOLNAFTATEOncora Pharma, LLCb28ee9f2-fc45-4336-b374-be7aa51d44e92026-05-11WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLEA-S Medication Solutionsc0f58a0d-a304-41f9-bbdf-c2e488230cf02026-05-11WarningsExact identifier
application number: M005
Inlifay ANTIFUNGALTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd5148b838-d26e-cf66-e063-6394a90ae4692026-05-09WarningsExact identifier
application number: M005
HuiPoLii NAIL PFLASTERTOLNAFTATE 1% NAIL PFLASTERJiangxi Yudexi Pharmaceutical Co., LTD514b1c2d-cecb-30a2-e063-6394a90af2662026-05-08WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103951tolnaftate 1 % Topical CreamPSN6301ab99-1757-144a-e053-2a91aa0adb777
103951tolnaftate 10 MG/ML Topical CreamSCD6301ab99-1757-144a-e053-2a91aa0adb777
103951tolnaftate 1 % Topical CreamSY6301ab99-1757-144a-e053-2a91aa0adb777

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65923-021-28659230021281 TUBE in 1 CARTON (65923-021-28) / 28 g in 1 TUBE1 tube2017-01-020000-00-00NoNoCurrent