FDA.reportPublic FDA data

sunmark

Product NDC
49348-155
11-digit product format
493480155
Labeler code
49348
Product ID
49348-155_395d4598-f05f-793e-e063-6294a90a79a5
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
2006-02-17
Marketing end
2027-03-31
Substance
TOLNAFTATE
Active strength
10 mg/g
NDC exclude flag
No
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

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
d0c30c74-9472-4978-9623-8c7dbeb99411Available 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
49348-155-29sunmarkantifungal1 in 1 CARTONCREAM15
49348-155-29sunmarkantifungal15 g in 1 TUBECREAM155

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-155-29GM - Gram49348-15525c29254-5bd6-4929-9c64-47955ba1ba8512013-02-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TolnaftateACTIVE INGREDIENT06KB629TKVSUNMARK ANTIFUNGAL (TOLNAFTATE) CREAM [MCKESSON]1
TolnaftateACTIVE MOIETY06KB629TKVSUNMARK ANTIFUNGAL (TOLNAFTATE) CREAM [MCKESSON]1
Butylated HydroxytolueneINACTIVE INGREDIENT1P9D0Z171KSUNMARK ANTIFUNGAL (TOLNAFTATE) CREAM [MCKESSON]1
petrolatumINACTIVE INGREDIENT4T6H12BN9USUNMARK ANTIFUNGAL (TOLNAFTATE) CREAM [MCKESSON]1
Polyethylene Glycol 3350INACTIVE INGREDIENTG2M7P15E5PSUNMARK ANTIFUNGAL (TOLNAFTATE) CREAM [MCKESSON]1
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQSUNMARK ANTIFUNGAL (TOLNAFTATE) CREAM [MCKESSON]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSUNMARK ANTIFUNGAL (TOLNAFTATE) CREAM [MCKESSON]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-155SUNMARK ANTIFUNGAL (TOLNAFTATE) CREAM [STRATEGIC SOURCING SERVICES LLC]4Current NDC, Legacy NDC, 2 package rows20241211_d0c30c74-9472-4978-9623-8c7dbeb99411.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 22 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Select Advanced Hand SanitizerALCOHOLLiving Better Brands LLC6d1cc25b-d612-4aae-bdb0-304758ef8f0f2026-01-26WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLEPadagis Israel Pharmaceuticals Ltd3dcd0158-ec51-4fa7-a26a-02c2926156c02026-01-22WarningsExact identifier
application number: M005
Puriya Antifungal BalmZINC UNDECYLENATEIPC Republic, Inc.96bf44bc-b5eb-4198-9056-02e51665a1622026-01-22WarningsExact identifier
application number: M005
BZK AntisepticBENZALKONIUM CHLORIDELights Medical Manufacture Co., Ltd.698ed472-9204-46e3-95a4-d59e204628ac2026-01-21WarningsExact identifier
application number: M005
LIGHTS SwabstickBENZALKONIUM CHLORIDELights Medical Manufacture Co., Ltd.9346512e-53a1-420a-8b4d-bfbec32576a22026-01-21WarningsExact identifier
application number: M005
Lights Isopropyl Alcohol Prep PadsISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.4905a27c-6cf8-4b1a-a02c-4c81756e8c0a2026-01-21WarningsExact identifier
application number: M005
Bee Venom Fungal Nail Treatment LiquidBEE VENOM FUNGAL NAIL TREATMENTShenzhen Earth Surface Trading Co., Ltd.48d164bc-dab6-6fe4-e063-6394a90a3fc42026-01-20WarningsExact identifier
application number: M005
TolnaftateMEIJER ATHLETES FOOT LIQUID SPRAYMeijer Distribution Inc.d9f7753f-aef9-86e2-e053-2995a90a20822026-01-20WarningsExact identifier
application number: M005
TolnaftateFOOT ODOR CONTROL POWDER SPRAYMeijer Distribution Incb3ba676e-9377-4665-b99e-d4143df96b362026-01-20WarningsExact identifier
application number: M005
TolnaftateMEIJER ATHLETES FOOT LIQUIDMeijer Distribution Inc.0399dfef-9ea6-6fe4-e063-6394a90aec432026-01-20WarningsExact identifier
application number: M005
TOENAIL FUNGUS TREATMENT MAXIMUM STRENGTH LiquidTOLNAFTATEShenzhen Ctrip Technology Co., Ltd.1fb03184-5f21-c82a-e063-6294a90a9fa42026-01-19WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATEAvKARE1a26534d-eeb8-8d17-e063-6294a90a70c72026-01-19WarningsExact identifier
application number: M005
Hermon Antifungal Soap. 4 packsTOLNAFTATE 1%Beautivity LLC42c769de-f1e1-b3a1-e063-6394a90ab2a12026-01-18WarningsExact identifier
application number: M005
Hermon Antifungal Cleansing BarTOLNAFTATE 1%Beautivity LLC48b5d7b3-a134-ecdd-e063-6294a90a32132026-01-18WarningsExact identifier
application number: M005
ANTIFUNGAL TOENAIL FUNGUS PENUNDECYLENIC ACIDYunqi Cosmetics (Shenzhen) Co., Ltd48b5fbd9-bdf5-21ac-e063-6394a90aa6b62026-01-18WarningsExact identifier
application number: M005
Hermon Antifungal Soap.TOLNAFTATE 1%Beautivity LLC41e37014-549c-e592-e063-6294a90ac6ab2026-01-17WarningsExact identifier
application number: M005
Hermon Antifungal .soap.TOLNAFTATE 1%Beautivity LLC482c338f-870f-f6d7-e063-6394a90a432c2026-01-17WarningsExact identifier
application number: M005
MEOLY Fungal Nail RenewalFUNGAL NAIL RENEWALShenzhen Xinxin Yunhai Technology Co., Ltd.487d2e22-6328-893f-e063-6394a90a9dff2026-01-16WarningsExact identifier
application number: M005
Lotrimin AntifungalMICONAZOLE NITRATEBayer HealthCare LLC.cebd222c-074f-443c-bd37-612114b27bbd2026-01-16WarningsExact identifier
application number: M005
Lotrimin Daily PreventionTOLNAFTATEBayer HealthCare LLC.9e8f9211-e85d-725a-e053-2995a90a09b32026-01-16WarningsExact 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
103951tolnaftate 1 % Topical CreamPSNd0c30c74-9472-4978-9623-8c7dbeb994115
103951tolnaftate 10 MG/ML Topical CreamSCDd0c30c74-9472-4978-9623-8c7dbeb994115
103951tolnaftate 1 % Topical CreamSYd0c30c74-9472-4978-9623-8c7dbeb994115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-155-29493480155291 TUBE in 1 CARTON (49348-155-29) / 15 g in 1 TUBE1 tube2013-02-132027-03-31NoNoCurrent