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Hermon Balanitis relief kit Sulfur 1X HPUS Kit — NDC 85398-0014-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Hermon Balanitis relief kit Sulfur 1X HPUS Kit — NDC 85398-014-01 (Billing 85398-0014-01)

by Beautivity LLC · 1 KIT in 1 CARTON * 116 g in 1 CARTON * 58 g in 1 BOTTLE

This is a package of Hermon Balanitis relief kit Sulfur 1X HPUS Kit from Beautivity LLC, marketed since Sep 2025 and currently FDA-listed. It is this product's only package size.

NDC 85398-0014-01
🏷️ FDA NDC (as labeled) 85398-014-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85398-014-01
Product NDC 85398-014
11-digit billing NDC 85398001401
RxCUI 251267
UPC 0199284499775
Application # M005
SPL Set ID 3dce086e-a4eb-4b21-e063-6394a90aa1b2
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-09-17
Route TOPICAL
Dosage form KIT
Quick answers
  • RxCUI (RxNorm): 251267
Why two NDCs? The FDA registers this code as 85398-014-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 85398-0014-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Azole Antifungal class.

Pharmacologic class Azole Antifungal
Drug family (ATC) Antiinfectives and antiseptics for local oral treatment, Imidazole and triazole derivatives, Imidazole derivatives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

🧪 What is this product?

Hermon Balanitis Relief Kit is a topical OTC monograph product containing sulfur in homeopathic potency (1X HPUS). Sulfur appears in many OTC skin care preparations and is typically used to address minor skin irritation and inflammation. This kit format allows for application to the affected area as part of routine personal care.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
85398-0014-01 You're viewing this Main listing 1 KIT in 1 CARTON * 116 g in 1 CARTON * 58 g in 1 BOTTLE 2025-09-17 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Easment Itch Defense Sulfur Cream 1 [hp_X]/60g 87352-0003-01 Easment 60 g — — FDA listed —
Hermon Balanitis relief kitthis 85398-0014-01 Beautivity 1 kit — — FDA listed —
Hermon Balanitis Cream 1 [hp_X]/58g; 1 [hp_X]/58g 85398-0013-01 Beautivity 58 g — — FDA listed —
Easment Itch Defense Sulfur Cream 1 [hp_X]/120g 87352-0006-01 Easment 120 g — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Sep 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

From the label’s inactive-ingredient sectionCream: Water (Aqua), Simmondsia chinensis (Jojoba) Seed Oil, Glycerin, Squalane, Cetearyl Alcohol, Cetearyl Olivate, Sorbitan Olivate, Butyrospermum Parki (Shea) Butter, Lithospermum Erythrorhizon Root Extract, ZincOxide, Silver, Allantoin, Centella Asiatica Extract, Beta-Glucan, Chrysanthellum indicum Extract, Hydroxyace-tophenone, Honey Extract, 1,2-Hexanediol, Camellia Sinensis (Green Tea) Leaf Extract, Curcuma Longa(Turmeric) Root Extract, Microsilver BG", Tocopheryl Acetate, Lavandula Angustifolla (Lavender) Oil, CeramideNP, Sodium Hyaluronate, Menthol, Chlorhexidine Acetate. Soap Bar: Melaleuca Alternifolia (Tea Tree) Leaf Oil, Water, Sorbitol, Elaeis Guineensis (Palm) Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Propylene Glvcol, Glycerin, Stearic Acid, Lauric Acid. Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hydroxide, Sodium Dodecylbenzene Sulfonate,Sulfur Thermal Water, Hamamelis Virginiana (Witch Hazel) Extract, Ceramide.

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerBeautivity LLC
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code85398
First marketedSep 2025
Product typeHuman Otc Drug
Portfolio36 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 79 words ▾

For Cream: Apply a thin layer to clean, dry skin 1-2 times daily or as needed. For first-time users,test on a small patch of skin before full application. Massage gently until fully absorbed.

For bestresults, use after cleansing with the antifungal soap. For Soap Bar: Wash affected area and dry thoroughly. Allow the lather to remain on skin for 1-2minutes before rinsing.

Ensure the affected area is dried completely before applying cream. Use 1-2times daily or directed by doctor.

⏱️ Dosage and Administration 19 words ▾

Helps relieve redness, itching, and irritation from balanitis, and soothes discomfort from other fungus-related skin conditions in sensitive areas.

⚠️ Warnings 57 words ▾

For external use only children under 2 years of age unless directed by adoctor. avoid contact with the eyes. if contact occurs, rinse the eyes very thoroughly with water. if irritation occurs, symptoms persist for more than 2 weeks, or symptoms worsen after initial improvement lf swallowed,get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 13 words ▾

Sulfur 1X HPUS (cream) Symphytum Officinale (Comfrey) 1X HPUS (Cream) Clotrimazole 1%(Soap Bar)

🧪 Inactive Ingredients 111 words ▾

Cream: Water (Aqua), Simmondsia chinensis (Jojoba) Seed Oil, Glycerin, Squalane, Cetearyl Alcohol, Cetearyl Olivate, Sorbitan Olivate, Butyrospermum Parki (Shea) Butter, Lithospermum Erythrorhizon Root Extract, ZincOxide, Silver, Allantoin, Centella Asiatica Extract, Beta-Glucan, Chrysanthellum indicum Extract, Hydroxyace-tophenone, Honey Extract, 1,2-Hexanediol, Camellia Sinensis (Green Tea) Leaf Extract, Curcuma Longa(Turmeric) Root Extract, Microsilver BG", Tocopheryl Acetate, Lavandula Angustifolla (Lavender) Oil, CeramideNP, Sodium Hyaluronate, Menthol, Chlorhexidine Acetate.

Soap Bar: Melaleuca Alternifolia (Tea Tree) Leaf Oil, Water, Sorbitol, Elaeis Guineensis (Palm) Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Propylene Glvcol, Glycerin, Stearic Acid, Lauric Acid. Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hydroxide, Sodium Dodecylbenzene Sulfonate,Sulfur Thermal Water, Hamamelis Virginiana (Witch Hazel) Extract, Ceramide.

🎯 Purpose 9 words ▾

Antifungal, itch relief. Helps relieve inflammation and irritation Antifungal

📄 Do Not Use 10 words ▾

children under 2 years of age unless directed by adoctor.

📄 Ask a Doctor Before Use If 16 words ▾

if irritation occurs, symptoms persist for more than 2 weeks, or symptoms worsen after initial improvement

📄 When Using This Product 15 words ▾

avoid contact with the eyes. if contact occurs, rinse the eyes very thoroughly with water.

📄 Keep Out of Reach of Children 12 words ▾

lf swallowed,get medical help or contact a Poison Control Center right away.

📄 Other Information 3 words ▾

store at 59-86°F(15-30°C)

📄 Questions or Comments 4 words ▾

visit us at www.hermonhealth.com

📄 Package Label / Principal Display Panel 1 words ▾

package

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Over-the-counter (OTC) product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Beautivity LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Beautivity LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 85398-0013-01 · Beautivity 85398-0015-01 · Beautivity →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.