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Olive Leaf Acne Remedy Topical Skin Relief 12 [hp_X]/mL; 12 [hp_X]/mL; 6 [hp_X]/mL; 30 [hp_X]/mL Liquid

by Vitality Works, Inc · 1 BOTTLE, PLASTIC in 1 CARTON (64616-069-02) / 30 mL in 1 BOTTLE, PLASTIC (64616-069-01)
NDC 64616-0069-02
🏷️ FDA NDC (as labeled) 64616-069-02 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 64616-069-02
Product NDC 64616-069
11-digit billing NDC 64616006902
UNII F79059A38U, E934B3V59H, 3BA2N709NG, L6L8KA2AA0
UPC 0019277000675
SPL Set ID ca137d01-9feb-446a-8410-3d553e54ee50
Established class (EPC) Blood Coagulation Factor; Cations; Phosphate Binder
Mechanism of action Phosphate Chelating Activity
Physiologic effect Increased Coagulation Factor Activity
Chemical class Calcium; Divalent
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-04-20
Route TOPICAL
Dosage form LIQUID
Substance ANTIMONY TRISULFIDE; CALCIUM SULFATE ANHYDROUS; JUGLANS REGIA FLOWERING TOP; SULFUR IODIDE
Why two NDCs? The FDA registers this code as 64616-069-02 — 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 → 64616-0069-02. 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.

🏭 Manufacturer & labeler

LabelerVitality Works, Inc
Labeler code64616
First marketedApr 2011
Product typeHuman Otc Drug
Portfolio8 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.

🩺 Clinical

🧪 What is this product?

Olive Leaf Acne Remedy is a homeopathic liquid applied to the skin. It contains several ingredients traditionally used in homeopathic practice, including antimony trisulfide, calcium sulfate, walnut flowering top, and sulfur iodide. Homeopathic products are marketed based on homeopathic theory and tradition; they are not evaluated by the FDA for safety or effectiveness. This product is intended for topical skin relief and is sold as an over-the-counter homeopathic remedy.

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.

🧪 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 F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII NDT563S5VZ
    A salt derived from the chemical compound EDTA, used as a chelating agent and preservative. It binds to metal ions in the formulation to prevent spoilage and maintain product stability.
  • UNII MJ95C3OH47
    A plant extract from olive leaves used in formulations as an antioxidant and preservative. It helps protect the medicine from degradation and extend shelf life.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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.

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

The official label also statesUSP Purified Water, Xylitol powder, Sodium Chloride, Olive Leaf Extract (Olea europa) 4X, Grapefruit Seed Extract, Sodium Hydroxide (for pH balance)

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.

💲 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 mLPer 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Olive Leaf Acne Remedy 12 [hp_X]/mL; 12 [hp_X]/mL; 6 [hp_X]/mL; 30 [hp_X]/mLthis 64616-0069-02 Vitality 1 bottle — — 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

🏛️
2011
On the market since
Apr 2011
📍
2026
Currently FDA-listed
15 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
64616-0069-02 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (64616-069-02) / 30 mL in 1 BOTTLE, PLASTIC (64616-069-01) 2011-04-20 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

Olive Leaf Acne Remedy Topical Skin Relief 12 [hp_X]/mL; 12 [hp_X]/mL; 6 [hp_X]/mL; 30 [hp_X]/mL LIQUID 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 — Not published for this NDC No photo available yet for this listing.
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 FDA registers it as 64616-069-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 64616-0069-02, written without dashes as 64616006902. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 64616-0069-02, the first segment (64616) is the labeler code FDA assigned to Vitality Works, Inc; the middle segment (0069) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Vitality Works, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Vitality Works, 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.

📄 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
🎯 Indications and Usage 29 words ▾

Olive Leaf Acne Remedy For the temporary relief of symptoms of acne, pimples, and cold sores. For the temporary relief of eczema, burning and itching, and skin pustular eruptions.

⏱️ Dosage and Administration 61 words ▾

Olive Leaf Acne Remedy - First, thoroughly wash hands and the affected areas of the skin with warm soapy water, and rinse. Dry thoroughly. - Apply a drop to fingertip and gently apply on affected skin. - Repeat 2-3 times per day. - For best results, continue using for a least one week after syptoms disappear. - Reapply if symptoms return.

⚠️ Warnings 83 words ▾

Olive Leaf Acne Remedy -Do not apply in or around eyes. This product will sting your eyes. If product should get into your eyes, rinse with warm water. -As with any drug.

If you are pregnanat or nursing a baby, seek the advice of a health care professional before using this product. -In case of accidental overdose by ingestion, seek profesional assistance or contact a poison control center immediately. All the ingredients are edible. However this product is not designed for internal use.

🧪 Active Ingredient 16 words ▾

Olive Leaf Acne Remedy Antimonium crudum 12X Calcarea sulfurica 12X Juglans regia 6X Sulphur iodatum 30X

🧪 Inactive Ingredients 25 words ▾

Olive Leaf Acne Remedy USP Purified Water, Xylitol powder, Sodium Chloride, Olive Leaf Extract (Olea europa) 4X, Grapefruit Seed Extract, Sodium Hydroxide (for pH balance)

🎯 Purpose 56 words ▾

Olive Leaf Acne Remedy Antimonium crudum - Relieves pimples; pustular eruptions with burning and itching; eczema Calcarea sulfurica - Relieves pimples and pustules on the face and under hair Juglans regia - Relives acne; itching; pimples on face, neck, shoulder and back Sulphur iodatum - Relieves acne, itching; cold sores on lips; pustules on uppler lip

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 64616-0055-02 · Vitality 64616-0072-01 · Vitality →
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.