FDA.reportPublic FDA data

Puriya Antifungal Balm

Product NDC
84711-001
11-digit product format
847110001
Labeler code
84711
Product ID
84711-001_63cc3983-9c85-47de-be38-f92c5070e551
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC UNDECYLENATE
Dosage form
CREAM
Route
TOPICAL
Labeler
IPC Republic, Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-04
Substance
ZINC UNDECYLENATE
Active strength
5.7 g/57g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Puriya Antifungal Balm
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC UNDECYLENATE5.7 g/57g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
388VZ25DURInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2553201Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
96bf44bc-b5eb-4198-9056-02e51665a162Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84711-001-02Puriya Antifungal Balm1 in 1 BOXCREAM12
84711-001-02Puriya Antifungal Balm5.7 g in 1 JARCREAM5.72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84711-001PURIYA ANTIFUNGAL BALM (ZINC UNDECYLENATE) CREAM [IPC REPUBLIC, INC.]1Current NDC, 2 package rows20241027_96bf44bc-b5eb-4198-9056-02e51665a162.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 5 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SERYNTH Multi-Purpose Nail SolutionTOLNAFTATE 1% MULTI-PURPOSE NAIL SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4a4af770-2bba-52a8-e063-6294a90ac2872026-07-21WarningsExact identifier
application number: M005
SERYNTH ClotrimazoleCLOTRIMAZOLE1% CLOTRIMAZOLEJiangxi Yudexi Pharmaceutical Co., LTD4a4b304a-1acc-9185-e063-6394a90a11762026-07-21WarningsExact identifier
application number: M005
SERYNTH FUNGI NAILTOLNAFTATE 1% FUNGI NAILJiangxi Yudexi Pharmaceutical Co., LTD4a4c6b7a-3c3e-1510-e063-6294a90a409a2026-07-21WarningsExact identifier
application number: M005
SERYNTH HELPS WITH FUNGAL NAILTOLNAFTATE 1% HELPS WITH FUNGAL NAILJiangxi Yudexi Pharmaceutical Co., LTD4a4c9ad1-e652-2b3b-e063-6394a90a29352026-07-21WarningsExact identifier
application number: M005
DERMFREE HELPS WITH NAGELPILZTOLNAFTATE 1% HELPS WITH NAGELPILZJiangxi Yudexi Pharmaceutical Co., LTD4a4d9361-3633-59b2-e063-6294a90aa3ea2026-07-21WarningsExact identifier
application number: M005
OURUI ONE FUNGAL NAIL TREATMENTTOLNAFTATE 1% FUNGAL NAIL TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4a473f03-f4cc-74ef-e063-6394a90ac7072026-07-20WarningsExact identifier
application number: M005
AVENASTER FUNGAL NAIL CARE DUO SET (NIGHT)UNDECYLENIC ACID 25% FUNGAL NAIL CARE DUO SET (NIGHT)Jiangxi Yudexi Pharmaceutical Co., LTD51eb8766-cc94-360d-e063-6294a90a69532026-07-20WarningsExact identifier
application number: M005
TINGOLE FUNGAL NAIL PatchesTOLNAFTATE 1% FUNGAL NAIL PATCHESJiangxi Yudexi Pharmaceutical Co., LTD5272c6fa-75f7-c698-e063-6394a90ac81e2026-07-20WarningsExact identifier
application number: M005
Vamy ANTIFUNGALTOLNAFTATE 1% ANTIFUNGALJiangxi Yudexi Pharmaceutical Co., LTD4dfdf3a2-95a8-9176-e063-6294a90a64de2026-07-20WarningsExact identifier
application number: M005
Antifungal creamANTIFUNGAL CREAMShenzhen Earth Surface Trading Co., Ltd.5708cc16-9a26-fd3c-e063-6394a90ac0ee2026-07-20WarningsExact identifier
application number: M005
TrpWinner TOENAIL FUNGUS PENUNDECYLENIC ACID 25% TOENAIL FUNGUS PENJiangxi Yudexi Pharmaceutical Co., LTD523c2a9c-3b35-bf73-e063-6394a90ae17d2026-07-20WarningsExact identifier
application number: M005
Charmpoo Antifungal CreamMICONAZOLE NITRATE 2% ANTIFUNGAL CREAMJiangxi Yudexi Pharmaceutical Co., LTD4ac347b5-d21b-cc9a-e063-6394a90a54962026-07-20WarningsExact identifier
application number: M005
Charmpoo TINEA VERSICOLOR TREATMENT ANTIFUNGALCLOTRIMAZOLE 1% TINEA VERSICOLOR TREATMENT ANTIFUNGALJiangxi Yudexi Pharmaceutical Co., LTD4ac31b1d-59d7-f45c-e063-6294a90a0d3d2026-07-20WarningsExact identifier
application number: M005
IraEvanes ANTIFUNGAL FOOTTOLNAFTATE 1% ANTIFUNGAL FOOTJiangxi Yudexi Pharmaceutical Co., LTD4d851a99-a453-e829-e063-6294a90a91182026-07-20WarningsExact identifier
application number: M005
LYSSERA Fungal Nail RenewalUNDECYLENIC ACID 25% ANTIFUNGAJiangxi Yudexi Pharmaceutical Co., LTD4dea6df4-e66b-c24a-e063-6294a90afca72026-07-20WarningsExact identifier
application number: M005
Kakalsa TOENAIL FUNGUS TREATMENTUNDECYLENIC ACID 25% TOENAIL FUNGUS TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD5123c0c3-bba8-d61c-e063-6394a90aab702026-07-20WarningsExact identifier
application number: M005
SOVS FUNGAL NAIL REPAIR RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL REPAIR RENEWALJiangxi Yudexi Pharmaceutical Co., LTD536b0c48-691e-755b-e063-6294a90a778e2026-07-20WarningsExact identifier
application number: M005
Tea Tree AntifungalCLOTRIMAZOLEHONG KONG UNORDERED TRADING CO., LIMITED56de35b7-b57d-1c62-e063-6294a90a757d2026-07-18WarningsExact identifier
application number: M005
ACTIV-CHARCOAL ANTIFUNGALTOLNAFTATEHONG KONG UNORDERED TRADING CO., LIMITED56def103-40ef-cd88-e063-6394a90a07172026-07-18WarningsExact identifier
application number: M005
SOVS MULTI-PURPOSE NAIL REPAIRTOLNAFTATE 1% MULTI-PURPOSE NAIL REPAIRWenzhou Yuyuan Pharmaceutical Co., Ltd.56df87a7-7fc2-5ba4-e063-6394a90a652b2026-07-18WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2553201zinc undecylenate 10 % Topical CreamPSN96bf44bc-b5eb-4198-9056-02e51665a1622
2553201zinc undecylenate 100 MG/ML Topical CreamSCD96bf44bc-b5eb-4198-9056-02e51665a1622
2553201zinc undecylenate 10 % Topical CreamSY96bf44bc-b5eb-4198-9056-02e51665a1622

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84711-001-02847110001021 JAR in 1 BOX (84711-001-02) / 5.7 g in 1 JAR1 jar2021-06-04NoNoCurrent