FDA.reportPublic FDA data

Hermon Balanitis relief kit

Product NDC
85398-014
11-digit product format
853980014
Labeler code
85398
Product ID
85398-014_3dce086e-a4ec-4b21-e063-6394a90aa1b2
Type
HUMAN OTC DRUG
Nonproprietary name
Sulfur 1X HPUS
Dosage form
KIT
Route
TOPICAL
Labeler
Beautivity LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-17
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
Hermon Balanitis relief kit
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
251267Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3dce086e-a4eb-4b21-e063-6394a90aa1b2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85398-011-01Hermon Balanitis relief kit116 g in 1 CARTONSOAP1 g in 1161.16 g in 116g1
85398-013-01Hermon Balanitis relief kit58 g in 1 BOTTLECREAM58 g1 [hp_X] in 58g1
85398-014-01Hermon Balanitis relief kit1 in 1 CARTONKIT11

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 34 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClotrimazoleCLOTRIMAZOLEAvPAK3ca3b475-7b69-442a-e063-6294a90a7b3f2025-08-18WarningsExact identifier
application number: M005
Formula 3TOLNAFTATEThe Tetra Corporation0895274b-a09d-4264-a43f-852e44eb31632025-08-18WarningsExact identifier
application number: M005
Formula 7 - The SolutionTOLNAFTATEThe Tetra Corporation18619649-7f79-4b6e-8b7c-69d70365d5572025-08-18WarningsExact identifier
application number: M005
GlyCylicSALICYLIC ACIDThe Tetra Corporation501d3ba9-ba42-4c1c-983b-492adaee039d2025-08-18WarningsExact identifier
application number: M005
SupreH Ringworm Treatment BalmSUPREH RINGWORM TREATMENT BALMShenzhen Xinxin Yunhai Technology Co., Ltd.3c77222b-d92e-84b0-e063-6294a90aadd72025-08-16WarningsExact identifier
application number: M005
OetMoe Antifungal SolutionOETMOE ANTIFUNGAL SOLUTIONShenzhen Earth Surface Trading Co., Ltd.3c26d917-4186-6f02-e063-6394a90a99f62025-08-12WarningsExact identifier
application number: M005
Cureforte Anti Fungal Foot CareANTI FUNGAL FOOT CARE DROPSSTEEL CITY HEALTH PRIVATE LIMITED39f762a6-9d0c-8ded-e063-6394a90a36592025-08-11WarningsExact identifier
application number: M005
Derman Antifungal Powder TolnaftateTOLNAFTATETaisho Pharmaceutical California Inc.3a854765-740c-4719-8abf-4b3f932cdee02025-08-07WarningsExact identifier
application number: M005
Derman antifungal creamTOLNAFTATETaisho Pharmaceutical California Inc.15d9b3c9-01af-4083-a1bc-014505d8798d2025-08-07WarningsExact identifier
application number: M005
Maximum Strength Antifungal LiquidTOLNAFTATEHudson Health LLC24b22794-f9f8-6f32-e063-6394a90aec982025-08-07WarningsExact identifier
application number: M005
Toe Area TreatmentTOLNAFTATECVS17681cc8-fbb1-a0cf-e063-6294a90add182025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEFamily Dollar Services, Inc178e7b3f-949f-3f51-e063-6294a90a93952025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATELEADER/Cardinal Health 110, Inc.17695563-3765-74cb-e063-6294a90a61202025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATETarget Corporation1dff278f-47bc-459a-e063-6394a90a26462025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATETopCo Associates19c268a1-7b2e-63c9-e063-6394a90acddc2025-08-07WarningsExact identifier
application number: M005
Antifungal Liquid Maximum StrengthTOLNAFTATEWalgreens Company137eabb7-cb4f-1631-e063-6294a90ab8472025-08-07WarningsExact identifier
application number: M005
WCTNGO Fungal Nail Treatment SwabsTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3bad0d73-b33d-b962-e063-6294a90a7ba72025-08-06WarningsExact identifier
application number: M005
ONIADBA Nail Fungus Treatment PenTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3bad19f1-d5b3-c5de-e063-6294a90a0c032025-08-06WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEPremier Brands of America Inc2644ba07-aaee-6402-e063-6394a90a28272025-08-06WarningsExact identifier
application number: M005
Anti- Fungal Miconazole NitrateMICONAZOLE NITRATEPremier Brands of America Inc.f186bdc1-db6c-0fab-e053-2995a90a7c582025-08-06WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251267clotrimazole 1 % Medicated Bar SoapPSN3dce086e-a4eb-4b21-e063-6394a90aa1b21
251267clotrimazole 0.01 MG/MG Medicated Bar SoapSCD3dce086e-a4eb-4b21-e063-6394a90aa1b21
251267clotrimazole 1 % Medicated Bar SoapSY3dce086e-a4eb-4b21-e063-6394a90aa1b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85398-011-0185398001101116 g in 1 CARTON116 gHistorical
85398-013-018539800130158 g in 1 BOTTLE58 gHistorical
85398-014-01853980014011 KIT in 1 CARTON (85398-014-01) * 116 g in 1 CARTON (85398-011-01) * 58 g in 1 BOTTLE (85398-013-01) 1 kit2025-09-17NoNoCurrent