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 42 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TolnaftateTOLNAFTATESheffield Pharmaceuticals LLCca52af37-c3a2-414c-a24a-a37a929251332025-02-20WarningsExact identifier
application number: M005
Dr Sheffield Athletes FootCLOTRIMAZOLESheffield Pharmaceuticals LLCb8b8e6b2-1022-4592-91ba-3cf94c7cf3182025-02-19WarningsExact identifier
application number: M005
UKVOA Toenail Fungus TreatmentTOLNAFTATE 1% FUNGI NAILJiashen International Trade Limited2e3cde7b-850e-f9d2-e063-6394a90adb182025-02-16WarningsExact identifier
application number: M005
UKOVA FOOT ODOR PROBIOTICTOLNAFTATE 1% FUNGI NAILJiashen International Trade Limited2de0225d-dd85-e2da-e063-6294a90a050b2025-02-11WarningsExact identifier
application number: M005
Dr. Scholls Instant Cool Athletes Foot WipesTOLNAFTATECosco International, Inc.cde656a9-7841-4a73-a2f4-f5a76a3e15c12025-02-06WarningsExact identifier
application number: M005
Silka Athletes FootMICONAZOLE NITRATEGenomma Lab USA307104a2-2df6-43b0-bf3f-f4d93d3e40f12025-02-05WarningsExact identifier
application number: M005
MICONAZOLE NitrateMICONAZOLE NITRATENuCare Pharmaceuticals,Inc.fd7dd2eb-03a7-ef1f-e053-6294a90a85572025-02-04WarningsExact identifier
application number: M005
Molecular AFTOLNAFTATERenu Laboratories, LLC1b47e687-29cf-48ce-8bc3-ac8f44f05baa2025-02-03WarningsExact identifier
application number: M005
Dermatool Fungal Nail TreatmentTOLNAFTATE 1%Papalo Group LLC2d2c0e12-123d-75bd-e063-6394a90ae5462025-01-31WarningsExact identifier
application number: M005
70% Isopropyl AlcoholISOPROPYL ALCOHOLIDO PHARMd5833c6f-81dd-6ff6-e053-2995a90ac76d2025-01-30WarningsExact identifier
application number: M005
AWAS ALCOHOLSPRAYALCOHOLIDO PHARM03010837-0289-3e08-e063-6394a90a7d042025-01-30WarningsExact identifier
application number: M005
ELON Dual Defense Anti Fungal FormulaUNDECYLENIC ACIDLittle Giant Holdings LLC45c4567d-7876-6459-e054-00144ff88e882025-01-28WarningsExact identifier
application number: M005
DCH Labs Antifungal JockMICONAZOLE NITRATE 2%Derma Care Research Labs, LLCfc749882-2e1e-cad3-e053-6294a90a33ca2025-01-27WarningsExact identifier
application number: M005
Antifungal PenUNDECYLENIC ACID 25%XF Agencija Limiteda15d4512-0fc6-424f-9dd3-ab433d9b7a262025-01-27WarningsExact identifier
application number: M005
Mata HongosUNDECYLENIC ACIDVitamex USA, Corp21ca7edb-dde3-5846-e063-6394a90a3cc02025-01-23WarningsExact identifier
application number: M005
Povidone Iodine ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd53cb4c0d-40b5-4cf3-b122-fd6dd654883f2025-01-23WarningsExact identifier
application number: M005
NATUREPLEX TOLNAFTATE ANTIFUNGALTOLNAFTATENatureplex, LLC575b8645-9166-4242-a74f-f4aa4acaaf3d2025-01-15WarningsExact identifier
application number: M005
Tobcharm Antifungal Treatment CreamANTIFUNGAL TREATMENT CREAMGuangzhou Zanming Trading Co., Ltd.2ba241cc-2767-1190-e063-6294a90ac66b2025-01-13WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2%MICONAZOLE NITRATEAkron Pharma Inc.8933f939-098a-4257-8d9c-4d5c3240e9a62025-01-10WarningsExact identifier
application number: M005
ANTI-ITCH FEMININE CAREHYDROCORTISONE 0.5%OL PHARMA TECH, LLC Drs PHARMACYd6fa5ff3-ebdc-222d-e053-2a95a90a88d52025-01-09WarningsExact 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