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Dermaharmony 10% Sulfur with Tea Tree Oil 10 g/100g Soap, 113 g — NDC 71819-0015-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dermaharmony 10% Sulfur with Tea Tree Oil 10 g/100g Soap, 113 g — NDC 71819-015-04 (Billing 71819-0015-04)

by D3 Development, Inc. · 113 g in 1 POUCH

This is a package of 113 g of Dermaharmony 10% Sulfur with Tea Tree Oil 10 g/100g Soap from D3 Development, Inc., marketed since Jul 2021 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 71819-0015-04
🏷️ FDA NDC (as labeled) 71819-015-04 billing pads the product segment with a zero
This package
Contains113 g Pack sizes2 compare ↓
Main listing for product 71819-015 · Also comes in: 113 g 71819-015-05
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) 71819-015-04
Product NDC 71819-015
11-digit billing NDC 71819001504
RxCUI 313147
UNII 70FD1KFU70
UPC 0860004825845
Application # M006
SPL Set ID c79005d4-0c6f-75d0-e053-2995a90a8314
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-07-20
Route TOPICAL
Dosage form SOAP
Substance SULFUR
Quick answers
  • RxCUI (RxNorm): 313147
Why two NDCs? The FDA registers this code as 71819-015-04 — 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 → 71819-0015-04. 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 Preparations containing sulfur class.

Drug family (ATC) Preparations containing sulfur
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?

Dermaharmony is a topical soap containing sulfur as its active ingredient. Sulfur is an OTC monograph ingredient commonly used in skin cleansing products for its potential keratolytic and antimicrobial properties. This soap is intended for cleansing the skin and is marketed as an over-the-counter drug product regulated under FDA guidelines for its category.

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.
Try another pack size: 113 g
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
71819-0015-04 You're viewing this Main listing 113 g in 1 POUCH 2021-07-20 — Active
71819-0015-05 71819-015-05 113 g in 1 CARTON 2025-12-01 — Active

Pack size FAQ

What quantity is in this package?
This package contains 113 g — 113 g in 1 pouch.
How does this package differ from NDC 71819-0015-05?
Both are Dermaharmony 10% Sulfur with Tea Tree Oil 10 g/100g Soap — the drug itself is identical. This page's package is the 113 g one, while NDC 71819-0015-05 is the 113 g package.
What NDC number is used to bill for this package of Dermaharmony 10% Sulfur with Tea Tree Oil 10 g/100g Soap?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dermaharmony 10% Sulfur 10 g/100g 71819-0014-04 D3 113 g — — FDA listed —
Dermaharmony 10% Sulfur with Tea Tree Oil 10 g/100gthis 71819-0015-04 D3 113 g — — FDA listed —
Earths Care Acne Spot Treatment 10 g/100g 24286-1557-01 DLC 1 tube — — FDA listed —
Acne Treatment with Sulfur 10 g/100g 24286-1574-01 DLC 74 g — — FDA listed —
Detoxify Facial Mask 10 g/100g 72957-0007-01 Private 85 g — — FDA listed —
Sulfur Calming Mask 10 g/100g 70764-0103-52 CONTROL 1 jar — — FDA listed —
Anti Acne Natural Volcanic Sulfur 10 g/100g 26050-0101-01 PT. 100 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

🏛️
2021
On the market since
Jul 2021
📍
2026
Currently FDA-listed
5 years 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3RT3536DHY
    A natural plant material derived from coconut that serves as a filler and texturizing agent in medicines. It helps give the product structure and consistency.
  • UNII 80T6U6714J
    A natural oil derived from the fruit of the oil palm plant. It serves as an emollient and lubricant in creams, lotions, and other topical formulations to help soften skin and improve product spreadability.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 961TOZ5L7T
    Pentasodium pentetate is a chelating agent, a chemical that binds and removes metal ions from solutions. In medicines, it helps prevent unwanted metal contamination and improves product stability during storage.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII R1TQH25F4I
    Sodium cocoate is a salt derived from coconut oil. It acts as an emulsifier and surfactant in medicines, helping to mix ingredients that normally don't blend together and improve product texture and stability.
  • UNII 6H91L1NXTW
    A processed palm kernel oil derivative used as an emulsifier and surfactant in medications. It helps mix oil and water-based ingredients together and improves how the medicine spreads and dissolves in the body.
  • UNII S0A6004K3Z
    Sodium palmate is a salt made from palm oil. It acts as an emulsifier and surfactant in medicines, helping mix ingredients that normally don't blend well together and improving product texture and consistency.
  • UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

10 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesInactive ingredients Sodium palmate, sodium cocoate*, sodium palm kernelate*, water, glycerin, tea tree (Melaleuca alternifolia) oil, sodium chloride, coconut (Cocos nucifera) fruit extract, palm (Elaeis guineensis) fruit extract, pentasodium penetate *May contain this ingredient

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerD3 Development, Inc.
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code71819
First marketedJul 2021
Product typeHuman Otc Drug
Portfolio19 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 12 words ▾

Uses For the treatment of acne. Clears acne blemishes, blackheads, and whiteheads.

⏱️ Dosage and Administration 68 words ▾

Directions using warm water, wash affected area for 1-2 minutes, avoiding contact with the eyes. rinse thoroughly and pat dry with a clean towel. because excessive drying of the skin may occur start with 1 application daily, then gradually increase to 2-3 times daily if needed or as directed by a doctor. if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

⚠️ Warnings 90 words ▾

Warnings For external use only Do not use on broken skin. large areas of the skin. When using this product apply only to areas with acne. skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Stop use and ask a doctor if skin irritation occurs or gets worse. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 10 words ▾

Other information Store at room temperature in a dry place.

🧪 Active Ingredient 4 words ▾

Active ingredient Sulfur 10%

🧪 Inactive Ingredients 34 words ▾

Inactive ingredients Sodium palmate, sodium cocoate*, sodium palm kernelate*, water, glycerin, tea tree (Melaleuca alternifolia) oil, sodium chloride, coconut (Cocos nucifera) fruit extract, palm (Elaeis guineensis) fruit extract, pentasodium penetate *May contain this ingredient

🎯 Purpose 4 words ▾

Purpose Acne medication soap

📄 Do Not Use 11 words ▾

Do not use on broken skin. large areas of the skin.

📄 When Using This Product 42 words ▾

When using this product apply only to areas with acne. skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

📄 Stop Use and Ask a Doctor If 13 words ▾

Stop use and ask a doctor if skin irritation occurs or gets worse.

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 3 words ▾

Questions? 1-800-827-3730 www.dermaharmony.com

📄 Package Label / Principal Display Panel 26 words ▾

dermaharmony 10% Sulfur SOAP with Tea Tree Oil For Acne Pimples, Blackheads & Whiteheads NET WT 4 OZ (113 G) Image of label image of carton

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
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 D3 Development, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 113 g (71819-0015-05). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
D3 Development, Inc. 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.
← 71819-0014-04 · D3 71819-0016-04 · D3 →
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.