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

Additional Listing Data#

Finished product
Yes
Brand name base
Hermon Balanitis Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFUR1 [hp_X]/58g
SYMPHYTUM OFFICINALE WHOLE1 [hp_X]/58g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii70FD1KFU70, H8FJJ6KX5Y

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
85398-013-01Hermon Balanitis relief kit58 g in 1 BOTTLECREAM58 g1 [hp_X] in 58g1
85398-013-01Hermon Balanitis Cream58 g in 1 BOTTLECREAM581

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
85398-013-018539800130158 g in 1 BOTTLE (85398-013-01) 58 g2025-09-15NoNoHistorical