Tolnaftate Antifungal

Product NDC
51672-2020
11-digit product format
516722020
Labeler code
51672
Product ID
51672-2020_38e4fe8a-5757-6a9c-e063-6394a90af25e
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1995-01-01
Substance
TOLNAFTATE
Active strength
1 g/100g
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
Tolnaftate Antifungal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1 g/100g

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
fa16fa08-fbbd-4f45-b64a-9bffe78e8861Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2020-1Tolnaftate Antifungal1 in 1 CARTONCREAM15
51672-2020-1Tolnaftate Antifungal15 g in 1 TUBECREAM155
51672-2020-2Tolnaftate Antifungal1 in 1 CARTONCREAM15
51672-2020-2Tolnaftate Antifungal30 g in 1 TUBECREAM305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2020-1GM - Gram51672-20203065f191-8b9f-462a-aab4-d7476df3a57112013-02-13
51672-2020-2GM - Gram51672-2020a24f5108-1a7f-4f7a-b78f-586f6403fb3c12013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2020TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4Current NDC, Legacy NDC, 4 package rows20241222_fa16fa08-fbbd-4f45-b64a-9bffe78e8861.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 40 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ELLEN HAND SANITIZER2ETHYL ALCOHOLPT. SUPER HOME PRODUCT INDONESIA334574b6-6d4a-bd37-e063-6394a90a67d62025-04-21WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEGERI-GENTLE CORPORATIONe6734616-c16b-430c-e053-2a95a90a18f82025-04-21WarningsExact identifier
application number: M005
Clotrimazole 1% Athletes FootCLOTRIMAZOLEGERI-GENTLE CORPORATIONe673748f-d00b-4ce8-e053-2995a90a92202025-04-21WarningsExact identifier
application number: M005
PHYTOZINE RINGWORM TREATMENT MAXIMUM STRENGTHTOLNAFTATEThe Sisquoc Healthcare Corporation5dff6ee7-f7a9-4841-8357-6b0801d253f12025-04-21WarningsExact identifier
application number: M005
HAND SANITIZERALCOHOLNINGBO TIANBO FIRST AID PRODUCT CO., LTD.88a14b15-09d6-45de-97b6-cddce7ca420b2025-04-19WarningsExact identifier
application number: M005
ELLEN HAND SANITIZERETHYL ALCOHOLPT. SUPER HOME PRODUCT INDONESIA33077eab-e686-249d-e063-6394a90a1b6d2025-04-18WarningsExact identifier
application number: M005
MEDI-FIRST First Aid AntisepticBENZALKONIUM CHLORIDEUltra Distributors Incb6efaca5-49d0-b000-e053-2995a90ab9aa2025-04-07WarningsExact identifier
application number: M005
ANTIBACTERIAL HAND SANITIZERETHYL ALCOHOLASC Marketing Ltd.b42ebe64-0cad-2d26-e053-2a95a90af3dd2025-04-07WarningsExact identifier
application number: M005
Anti-Bacterial HAND SANITIZERETHYL ALCOHOLDISNEY DESTINATIONS,LLCae739bda-edf3-634b-e053-2a95a90a73852025-04-07WarningsExact identifier
application number: M005
Hand SanitizerETHYL ALCOHOLOrazen Incaa846bb7-a64b-3358-e053-2995a90a9d092025-04-07WarningsExact identifier
application number: M005
Hand SanitizerETHYL ALCOHOLOrazen Inc9ae42862-f730-9d67-e053-2a95a90af9552025-04-07WarningsExact identifier
application number: M005
Hand SanitizerETHYL ALCOHOLOrazen Inc7e8f4517-c996-8797-e053-2991aa0a4f582025-04-07WarningsExact identifier
application number: M005
Hand SanitizerETHYL ALCOHOLRaining Rose, Inc.43ab2651-6e0a-3d48-e054-00144ff88e882025-04-07WarningsExact identifier
application number: M005
Folliculitis Treatment CreamMICONAZOLE NITRATETAGRID LLC32396be0-f74a-5483-e063-6294a90ab3ae2025-04-07WarningsExact identifier
application number: M005
Antifungal Treatment Liquid 25 undeclylenic AcidUNDECYLENIC ACIDSANSAR, LLC2ae0f300-154e-44c8-bcc3-b5c334e661ac2025-04-02WarningsExact identifier
application number: M005
BBlove ALCOHOL WIPESBBLOVE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD3126955d-8fd1-04f8-e063-6294a90a886f2025-03-31WarningsExact identifier
application number: M005
Tagrid Jock Itch Miconazole Nitrate 2%MICONAZOLE NITRATETAGRID LLC31abdc68-5027-15e7-e063-6394a90ac4e62025-03-31WarningsExact identifier
application number: M005
Tea Tree Oil Foot Soak and Body SoakZINC UNDECYLENATESANSAR, LLCc43816ac-2228-43ce-ba45-80cf3a7788f22025-03-28WarningsExact identifier
application number: M005
health beyond HAND SANITIZERALCOHOLNantong Health & Beyond Hygienic Products Inc.e5746be7-e9dc-42a6-a3d0-b386427caec52025-03-27WarningsExact identifier
application number: M005
Tagrit Antifungal Treament Ketoconazole 1%KETOCONAZOLETAGRID LLC315a8832-c42f-c07a-e063-6394a90a82182025-03-27WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103951tolnaftate 1 % Topical CreamPSNfa16fa08-fbbd-4f45-b64a-9bffe78e88615
103951tolnaftate 10 MG/ML Topical CreamSCDfa16fa08-fbbd-4f45-b64a-9bffe78e88615
103951tolnaftate 1 % Topical CreamSYfa16fa08-fbbd-4f45-b64a-9bffe78e88615
103951tolnaftate 1 % Topical CreamPSN2b2303dd-fec2-4ff4-a0ae-6bfb921dd2462
103951tolnaftate 10 MG/ML Topical CreamSCD2b2303dd-fec2-4ff4-a0ae-6bfb921dd2462
103951tolnaftate 1 % Topical CreamSY2b2303dd-fec2-4ff4-a0ae-6bfb921dd2462

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-2020-1516722020011 TUBE in 1 CARTON (51672-2020-1) / 15 g in 1 TUBE1 tube1995-01-010000-00-00NoNoCurrent
51672-2020-2516722020021 TUBE in 1 CARTON (51672-2020-2) / 30 g in 1 TUBE1 tube1995-01-010000-00-00NoNoCurrent