Home NDC 85398-014 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 Identifier FDA.report destination 251267 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85398-011-01 Hermon Balanitis relief kit 116 g in 1 CARTON SOAP 1 g in 116 1.16 g in 116g 1 85398-013-01 Hermon Balanitis relief kit 58 g in 1 BOTTLE CREAM 58 g 1 [hp_X] in 58g 1 85398-014-01 Hermon Balanitis relief kit 1 in 1 CARTON KIT 1 1
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 36 of 49 · 973 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85398-011-01 85398001101 116 g in 1 CARTON 116 g Historical 85398-013-01 85398001301 58 g in 1 BOTTLE 58 g Historical 85398-014-01 85398001401 1 KIT in 1 CARTON (85398-014-01) * 116 g in 1 CARTON (85398-011-01) * 58 g in 1 BOTTLE (85398-013-01) 1 kit 2025-09-17 No No Current