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Vitiligo Organics Cullen corylifolium whole plant, Berberis vulgaris root bark, Nigella sativa seed, Organic coconut oil 83 mg/125mL; 83 mg/125mL; 83 mg/125mL Ointment, 125 mL — NDC 70957-0020-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Vitiligo Organics Cullen corylifolium whole plant, Berberis vulgaris root bark, Nigella sativa seed, Organic coconut oil 83 mg/125mL; 83 mg/125mL; 83 mg/125mL Ointment, 125 mL — NDC 70957-0020-1 (Billing 70957-0020-01)

by Organic Care Australia Pty LTD · 125 mL in 1 BOTTLE

This is a package of 125 mL of Vitiligo Organics Cullen corylifolium whole plant, Berberis vulgaris root bark, Nigella sativa seed, Organic coconut oil 83 mg/125mL; 83 mg/125mL; 83 mg/125mL Ointment from Organic Care Australia Pty LTD, marketed since Sep 2016 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 70957-0020-01
🏷️ FDA NDC (as labeled) 70957-0020-1 billing pads the package segment with a zero
This package
Contains125 mL Pack sizes2 compare ↓
Main listing for product 70957-0020 · Also comes in: 250 ml 70957-0020-2
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 70957-0020-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
70957 labeler · 0020 product · 1 package
Package marketed since
Sep 7, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
9369999043612, 9369999043605
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70957-0020-1
Product NDC 70957-0020
11-digit billing NDC 70957002001
UNII M8Z0AK5HFO, 4LVZ0Z0ITT, 1TH8Q20J0U
UPC 9369999043612, 9369999043605
SPL Set ID 3bebd5f6-e5c1-0501-e054-00144ff8d46c
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-09-07
Route TOPICAL
Dosage form OINTMENT
Substance CULLEN CORYLIFOLIUM WHOLE; NIGELLA SATIVA SEED; BERBERIS VULGARIS ROOT BARK
Why two NDCs? The FDA registers this code as 70957-0020-1 — a 5-4-1 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 package segment → 70957-0020-01. 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.

Clinical

🧪 What is this product?

Vitiligo Organics is a homeopathic ointment applied to the skin containing extracts of Cullen corylifolium whole plant, Berberis vulgaris root bark, and Nigella sativa seed. In homeopathic tradition, these plant materials are used for skin concerns, particularly in formulations intended to address pigmentation issues. This product is marketed based on homeopathic principles and has not been evaluated by the FDA for effectiveness or safety.

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 gPer 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: 250 ml
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
70957-0020-01 You're viewing this Main listing 125 mL in 1 BOTTLE 2016-09-07 — Active
70957-0020-02 70957-0020-2 250 mL in 1 BOTTLE 2016-09-07 — Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 125 mL — 125 ml in 1 bottle.
How does this package differ from NDC 70957-0020-02?
Both are Vitiligo Organics Cullen corylifolium whole plant, Berberis vulgaris root bark, Nigella sativa seed, Organic coconut oil 83 mg/125mL; 83 mg/125mL; 83 mg/125mL Ointment — the drug itself is identical. This page's package is the 125 mL one, while NDC 70957-0020-02 is the 250 ml package.
What NDC number is used to bill for this package of Vitiligo Organics Cullen corylifolium whole plant, Berberis vulgaris root bark, Nigella sativa seed, Organic coconut oil 83 mg/125mL; 83 mg/125mL; 83 mg/125mL Ointment?
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
Vitiligo Organics 83 mg/125mL; 83 mg/125mL; 83 mg/125mLthis 70957-0020-01 Organic 125 ml — — 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

🏛️
2016
On the market since
Sep 2016
📍
2026
Currently FDA-listed
10 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.

  • 752 mg / 125 mL UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesCoconut Oil

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

LabelerOrganic Care Australia Pty LTD
Labeler code70957
First marketedSep 2016
Product typeHuman Otc Drug
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 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 12 words ▾

Usage Homeopathic remedy that helps in pigmentation of skin affected by vitiligo.

⏱️ Dosage and Administration 45 words ▾

Directions Clean the affected area Apply generously and massage into the skin every day and night before bed Leave it on without rinsing for 8-10 hours Lotion solidifies in cold weather. Immerse bottle in a warm bowl of water until liquefied Shake well before use

⚠️ Warnings 20 words ▾

Warnings • For external use only • If symptoms persist consult your healthcare practitioner • Store below 86 o F

🧪 Active Ingredient 15 words ▾

Actives Each 1g contains: Cullen corylifolium whole plant...83mg Berberis vulgaris root bark...83mg Nigella sativa seed...83mg

🧪 Inactive Ingredients 3 words ▾

Inactives Coconut Oil

🎯 Purpose 5 words ▾

Purpose For repigmentation of skin

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children

📄 Package Label / Principal Display Panel 6 words ▾

Product label image description image description

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 Homeopathic listing

About homeopathic listings

Vitiligo Organics Cullen corylifolium whole plant, Berberis vulgaris root bark, Nigella sativa seed, Organic coconut oil 83 mg/125mL; 83 mg/125mL; 83 mg/125mL OINTMENT is listed under the homeopathic marketing category. An NDC listing in this category does not by itself establish FDA approval, and FDA does not evaluate homeopathic products for effectiveness. This page reports the listing data as published.

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 "Unapproved Homeopathic". 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 Organic Care Australia Pty LTD. 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 250 ml (70957-0020-02). 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?
Organic Care Australia Pty LTD 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.
← 70954-0978-10 · ANI 70964-0001-01 · VitaminMed, →
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.