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 9 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LQNZJBAU Nail Repair PenUNDECYLENIC ACIDGuangzhou Xinhongda Trading Service Co., Ltd.55236084-42f4-6ada-e063-6394a90ac8462026-06-26WarningsExact identifier
application number: M005
VORVITA Nail HardenerPANTHENOL,HYALURONIC ACIDHK Vorvita Technology Co., Limited51d5d3c7-ca25-3ee5-e063-6294a90a3a052026-06-26WarningsExact identifier
application number: M005
natouchMICONAZOLENatouch LLC55210a9d-6c47-4fc7-e063-6294a90a36532026-06-25WarningsExact identifier
application number: M005
YEARCHOICE Fungal Nail Repair PenFUNGAL NAIL REPAIR PENGuangzhou Jingliang Cosmetics Co., Ltd.5500b582-0641-498d-e063-6394a90a3c582026-06-24WarningsExact identifier
application number: M005
FIobow FUNGAL NAIL TREATMENTTOLNAFTATE 1% FUNGAL NAIL TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4a49db2b-e45a-57c5-e063-6294a90a065c2026-06-23WarningsExact identifier
application number: M005
RoyceDerm Antifungal .spray.CLOTRIMAZOLE 1%RoyceDerm LLC54d3ae29-8919-4868-e063-6294a90a587e2026-06-22WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT LIQUIDWalgreens Company94f4f656-e8a3-4439-b53c-12be59dc8eac2026-06-20WarningsExact identifier
application number: M005
VTROUY Fungal Nail Renewal PenFUNGAL NAIL RENEWAL PENGuangzhou Jingliang Cosmetics Co., Ltd.549bf490-99c2-c800-e063-6394a90a672b2026-06-19WarningsExact identifier
application number: M005
Terramed Just Think Comfort Armor Antifungal Body Wash Tea TreeTOLNAFTATERida LLC0c7a3b2d-8b1c-4130-86ad-892a591574802026-06-19WarningsExact identifier
application number: M005
Terramed Just Think Comfort Clotrimazole Antifungal Topical SolutionCLOTRIMAZOLERida LLC83a9c5dc-c969-43a7-a763-44783710d5d02026-06-18WarningsExact identifier
application number: M005
Anytalk FUNGAL NAIL TREATMENTTOLNAFTATE 1%Guangzhou Huixue Biotechnology Co., Ltd.54718558-376f-ed31-e063-6294a90a52202026-06-17WarningsExact identifier
application number: M005
KLIPP FUNGAL NAIL TREATMENTKLIPP FUNGAL NAIL TREATMENTGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd547f2fbe-a2de-057d-e063-6394a90ac7422026-06-17WarningsExact identifier
application number: M005
GeriGentle Miconazole nitrateANTIFUNGALGERI-GENTLE CORPORATION0ae03b4a-06c8-ddf9-e063-6294a90ad1052026-06-16WarningsExact identifier
application number: M005
WKPIKI FUNGAL NAIL REPAIR PENUNDECYLENIC ACID 25% FUNGAL NAIL REPAIR PENWenzhou Yuyuan Pharmaceutical Co., Ltd.54472c44-93de-d4b9-e063-6394a90adde12026-06-15WarningsExact identifier
application number: M005
BIOSHUGA Dermomucosal Antibacterial GelBIOSHUGA DERMOMUCOSAL ANTIBACTERIAL GELGuangxi Rise Biological Technology Co.,Ltd.5456574a-dda4-9c67-e063-6294a90ac2222026-06-15WarningsExact identifier
application number: M005
BIOSHUGA CUTANEOUS MUCOSAL ANTIMICROBIAL SolutionBIOSHUGA CUTANEOUS MUCOSAL ANTIMICROBIAL SOLUTIONGuangxi Rise Biological Technology Co.,Ltd.5457a623-7812-e516-e063-6394a90a8bfd2026-06-15WarningsExact identifier
application number: M005
TOYKNIER MULTI-PURPOSE TREATMENTUNDECYLENIC ACID 25% MULTI-PURPOSE TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4f8eb3a3-8f26-50dd-e063-6294a90ad9f82026-06-14WarningsExact identifier
application number: M005
CYYZROSE ANTIFUNGAL NAILUNDECYLENIC ACID 25% ANTIFUNGAL NAILJiangxi Yudexi Pharmaceutical Co., LTD527765d4-6988-ed4e-e063-6394a90a2f232026-06-14WarningsExact identifier
application number: M005
HEALMUSZ FUNGAL NAILTOLNAFTATE 1% FUNGAL NAILJiangxi Yudexi Pharmaceutical Co., LTD4a2317d2-e45b-1fe2-e063-6394a90a940d2026-06-14WarningsExact identifier
application number: M005
HEALMUSZ FUNGI NAILTOLNAFTATE 1% FUNGI NAILJiangxi Yudexi Pharmaceutical Co., LTD4a23c01b-492d-324b-e063-6394a90a73b12026-06-14WarningsExact 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