FDA.reportPublic FDA data

sunmark

Product NDC
50090-3358
11-digit product format
500903358
Labeler code
50090
Product ID
50090-3358_3802e6c5-c6f6-4ed5-80c9-97e5b0a38a5d
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-02-17
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
sunmark
Brand name suffix
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
6f85fbb0-297c-4949-83f2-ed9a52172154Available 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
50090-3358-0sunmark antifungal1 in 1 CARTONCREAM19
50090-3358-0sunmark antifungal15 g in 1 TUBECREAM159

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3358-0GM - Gram50090-3358b2433655-9852-4534-83af-6fac4e7f784212019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3358SUNMARK ANTIFUNGAL (TOLNAFTATE) CREAM [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20231217_6f85fbb0-297c-4949-83f2-ed9a52172154.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 15 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREEWal-Mart Stores, Incaf4d4e9e-8678-3a80-e053-2995a90a677f2026-04-22WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYWal-Mart Stores, Incaf4ebb3b-041e-30dd-e053-2995a90a8d2d2026-04-22WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYWal-Mart Stores, Incaf4dd045-ca51-42b9-e053-2a95a90a03272026-04-22WarningsExact identifier
application number: M005
4ozMICONAZOLENabrace LLC4f912a20-e0f7-23c1-e063-6294a90a55d62026-04-18WarningsExact identifier
application number: M005
Nabrace Wipes for Ringworm, Jockitch and Athlete FeetNABRACE WIPES FOR RINGWORM, JOCKITCH AND ATHLETE FEETNabrace LLC4fc3ddc8-08a2-ae50-e063-6294a90a1e072026-04-18WarningsExact identifier
application number: M005
SimplyVital Antifungal ClotrimazoleCLOTRIMAZOLEAlpha Plants Inc44881106-3ab4-4103-9c48-1da435ab5b132026-04-16WarningsExact identifier
application number: M005
medicatedMICONAZOLENabrace LLC4f90d8ad-33d9-0043-e063-6394a90a44662026-04-16WarningsExact identifier
application number: M005
Ingrown Nail TreatmentJALAWEF INGROWN NAIL TREATMENTConsilii LLC1ac2d7fc-1806-7925-e063-6294a90ad3b52026-04-15WarningsExact identifier
application number: M005
RDVHDLW Extra Strength NAIL REPAIR PENTOLNAFTATE, UNDECYLENIC ACIDShenzhen Joyuflsh Technology Co.,Ltd.4f68796c-11e1-e5f7-e063-6394a90adeb12026-04-14WarningsExact identifier
application number: M005
ProBliva Psoriasis Scalp .spray.SALICYLIC ACID 3%CAVTECH HOLDING LLC4f695604-51c5-c1b7-e063-6294a90ab5ae2026-04-14WarningsExact identifier
application number: M005
OSIMOON Fungal Nail TreatmentFUNGAL NAIL TREATMENTGuangzhou Jingliang Cosmetics Co., Ltd.4f7817db-cd71-fba9-e063-6294a90a9cdf2026-04-14WarningsExact identifier
application number: M005
Quali Life ANTIFUNGAL PERSIMMONTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd4f520058-3b81-574e-e063-6294a90a2eae2026-04-13WarningsExact identifier
application number: M005
Quali Life ANTIFUNGAL CHARCOALTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd4f538041-e2f1-4a5f-e063-6294a90a54cf2026-04-13WarningsExact identifier
application number: M005
RoyceDerm tinea ANTIFUNGAL .cream. and .soap.CREAM AND SOAPRoyceDerm LLC4f4ef2d0-98fa-e791-e063-6394a90a70452026-04-12WarningsExact identifier
application number: M005
Nailtific Daytime Treatment Antifungal Pen RefillNAILTIFIC DAYTIME TREATMENT ANTIFUNGAL PEN REFILLGuangzhou Meixi Biotechnology Co., Ltd.4257ee32-0d8f-08d4-e063-6294a90a4a892026-04-11WarningsExact identifier
application number: M005
Nailtific Nighttime Antifungal Renewal Pen RefillTOLNAFTATEGuangzhou Meixi Biotechnology Co., Ltd.42634fc7-d0c7-4813-e063-6294a90a702d2026-04-11WarningsExact identifier
application number: M005
Maximum Strength Antifungal LiquidTOLNAFTATEChain Drug Marketing Association Inc1a4f4d10-6782-ddb4-e063-6294a90ac2062026-04-09WarningsExact identifier
application number: M005
Extra Strength Toenail Renewal SolutionUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eed68e6-6814-0181-e063-6394a90a888e2026-04-08WarningsExact identifier
application number: M005
TAGOQHIA Extra Strength NAIL REPAIR PENTOLNAFTATE, UNDECYLENIC ACIDGuangzhou Borderless Technology Co., Ltd.4eefbef4-7643-dca4-e063-6394a90a72c12026-04-08WarningsExact identifier
application number: M005
ZYNTHIXUNDECYLENIC ACID SOLUTIONShenzhen Siwei Yijiu Trading Co., Ltd.4ef4a167-f673-efb4-e063-6294a90a30262026-04-08WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103951tolnaftate 1 % Topical CreamPSN6f85fbb0-297c-4949-83f2-ed9a521721549
103951tolnaftate 10 MG/ML Topical CreamSCD6f85fbb0-297c-4949-83f2-ed9a521721549
103951tolnaftate 1 % Topical CreamSY6f85fbb0-297c-4949-83f2-ed9a521721549

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3358-0500903358001 TUBE in 1 CARTON (50090-3358-0) / 15 g in 1 TUBE1 tube2018-02-010000-00-00NoNoCurrent