FDA.reportPublic FDA data

Tolnaftate Antifungal

Product NDC
70677-1001
11-digit product format
706771001
Labeler code
70677
Product ID
70677-1001_39fad608-a813-37da-e063-6394a90acc98
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
CREAM
Route
TOPICAL
Labeler
STRATEGIC SOURCING SERVICES LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-22
Substance
TOLNAFTATE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
97ffb6fd-5670-4783-b805-88fe9e43ca96Available 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
70677-1001-1Tolnaftate Antifungal1 in 1 CARTONCREAM13
70677-1001-1Tolnaftate Antifungal15 g in 1 TUBECREAM153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1001-1GM - Gram70677-1001f4c6e659-e4d5-4eb6-bc23-21fbb4a674f212023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1001TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [STRATEGIC SOURCING SERVICES LLC]2Current NDC, 2 package rows20241109_97ffb6fd-5670-4783-b805-88fe9e43ca96.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 CreamPSN97ffb6fd-5670-4783-b805-88fe9e43ca963
103951tolnaftate 10 MG/ML Topical CreamSCD97ffb6fd-5670-4783-b805-88fe9e43ca963
103951tolnaftate 1 % Topical CreamSY97ffb6fd-5670-4783-b805-88fe9e43ca963

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1001-1706771001011 TUBE in 1 CARTON (70677-1001-1) / 15 g in 1 TUBE1 tube2023-06-22NoNoCurrent