Home NDC 85398-013 Hermon Balanitis Cream
Product NDC 85398-013
11-digit product format 853980013
Labeler code 85398
Product ID 85398-013_3dba4e4b-8225-6a96-e063-6394a90a9129
Type HUMAN OTC DRUG
Nonproprietary name Sulfur 1X HPUS
Dosage form CREAM
Route TOPICAL
Labeler Beautivity LLC
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-09-15
Substance SULFUR; SYMPHYTUM OFFICINALE WHOLE
Active strength 1; 1 [hp_X]/58g; [hp_X]/58g
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 Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULFUR 1 [hp_X]/58g SYMPHYTUM OFFICINALE WHOLE 1 [hp_X]/58g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 70FD1KFU70 Internal UNII lookup H8FJJ6KX5Y Internal UNII 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 85398-013-01 Hermon Balanitis relief kit 58 g in 1 BOTTLE CREAM 58 g 1 [hp_X] in 58g 1 85398-013-01 Hermon Balanitis Cream 58 g in 1 BOTTLE CREAM 58 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 8 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 85398-013-01 85398001301 58 g in 1 BOTTLE (85398-013-01) 58 g 2025-09-15 No No Current