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Detox Drops 2% Salicylic Acid Acne Toner 2 mg/100mg Liquid

by COSMAX USA, CORPORATION · 1 BOTTLE in 1 CARTON (68577-189-00) / 120 mg in 1 BOTTLE
NDC 68577-0189-00
🏷️ FDA NDC (as labeled) 68577-189-00 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) 68577-189-00
Product NDC 68577-189
11-digit billing NDC 68577018900
UNII O414PZ4LPZ
Application # M006
SPL Set ID 2999c85e-cb4b-719e-e063-6394a90a0f28
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-10-01
Route TOPICAL
Dosage form LIQUID
Substance SALICYLIC ACID
Why two NDCs? The FDA registers this code as 68577-189-00 — 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 → 68577-0189-00. 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

LabelerCOSMAX USA, CORPORATION
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code68577
First marketedOct 2024
Product typeHuman Otc Drug
Portfolio91 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?

Detox Drops 2% Salicylic Acid Acne Toner is a topical liquid containing salicylic acid, a beta hydroxy acid commonly used in over-the-counter acne products. Salicylic acid is typically used to help exfoliate skin and unclog pores as part of acne skincare routines. This product is marketed under the FDA's over-the-counter monograph rules for acne treatments, meaning it follows established safety and labeling standards for that drug category rather than undergoing individual FDA review.

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 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII YY7C30VXJT
    A natural plant extract from cucumber that adds flavor and freshness to medicines. It may also serve as a moisturizing agent or mild preservative in topical or oral formulations.
  • UNII Z17H97EA6Y
    A plant-derived mild cleanser made from natural sugars and oils. It acts as an emulsifier and surfactant to help mix water and oil-based ingredients together in the medicine.
  • 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 O84B5194RL
    A plant extract from juniper berries used as a flavoring agent to improve the taste of medicines. It may also contribute mild antimicrobial properties to support product stability.
  • UNII 33X04XA5AT
    Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
  • UNII 76LN7P7UCU
    Lauryl glucoside is a mild plant-based cleansing agent made from coconut oil and glucose. It's used in medicines as a surfactant to help dissolve and distribute ingredients evenly throughout the formulation.
  • UNII BQX4W45LG8
    A beneficial bacterium used as a probiotic ingredient. It helps maintain the medicine's stability and viability during storage and may support the product's intended health benefits through fermentation.
  • UNII 2BF9E65L7I
    A chemical compound combining menthol with lactic acid. It's used in medicines as a flavoring agent and to provide a cooling or soothing sensation on the skin or mouth.
  • UNII N8F53B3R4R
    A synthetic humectant and solvent derived from propane. It draws and holds moisture in the formulation, helping keep the medicine stable and improving texture or flow in liquid and semi-solid products.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • 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.

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

The official label also statesInactive Ingredients WATER, JUNIPERUS COMMUNIS FRUIT EXTRACT, POLYSORBATE 20, METHYLPROPANEDIOL, LACTOBACILLUS/SALIX PURPUREA BARK FERMENT EXTRACT, BUTYLENE GLYCOL, GLYCERIN, SODIUM HYDROXIDE, DECYL GLUCOSIDE, MENTHYL LACTATE, LACTOBACILLUS FERMENT, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, LAURYL GLUCOSIDE, CITRIC ACUD, LACTIC ACID.

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
Detox Drops 2% Salicylic Acid Acne Toner 2 mg/100mgthis 68577-0189-00 COSMAX 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

🏛️
2024
On the market since
Oct 2024
📍
2026
Currently FDA-listed
2 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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Salicylic Acid (matched by generic name) — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Salicylic Acid. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$11.2K
Claims incl. refills
43
Beneficiaries
35
Spend / beneficiary
$319.01
Spend / claim
$259.66
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Detox Drops 2% Salicylic Acid Acne Toner (this brand).

Top reported reactions

Vomiting216
Pruritus205
Weight Decreased188
Condition Aggravated184
Urticaria184
Weight Increased183
Hypertension181

Age at onset

Neonate7
Infant1
Child8
Adolescent5
Adult170
Elderly94

Reporter sex

1,853 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization623
Death611
Life-threatening174
Disabling124
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 243 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68577-0189-00 You're viewing this 1 BOTTLE in 1 CARTON (68577-189-00) / 120 mg in 1 BOTTLE 2024-10-01 Active

🧭 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 — 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 "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 FDA registers it as 68577-189-00, 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: 68577-0189-00, written without dashes as 68577018900. 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 68577-0189-00, the first segment (68577) is the labeler code FDA assigned to COSMAX USA, CORPORATION; the middle segment (0189) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 COSMAX USA, CORPORATION. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
COSMAX USA, CORPORATION 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 70 words ▾

USES Use For the treatment of acne. Clears acne blemishes and allows skin to heal. Helps prevent the development of new blemishes. When using this product 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 avoid contact with eyes if eye contact occurs, flush thoroughly with water

⏱️ Dosage and Administration 73 words ▾

DIRECTIONS Directions shake well before use clean skin thoroughly before applying this product cover the entire affected area with a thin layer one to three times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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 25 words ▾

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

🧪 Active Ingredient 5 words ▾

Active Ingredient Salicylic Acid 2%

🧪 Inactive Ingredients 37 words ▾

Inactive Ingredients WATER, JUNIPERUS COMMUNIS FRUIT EXTRACT, POLYSORBATE 20, METHYLPROPANEDIOL, LACTOBACILLUS/SALIX PURPUREA BARK FERMENT EXTRACT, BUTYLENE GLYCOL, GLYCERIN, SODIUM HYDROXIDE, DECYL GLUCOSIDE, MENTHYL LACTATE, LACTOBACILLUS FERMENT, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, LAURYL GLUCOSIDE, CITRIC ACUD, LACTIC ACID.

🎯 Purpose 3 words ▾

Purpose Acne medication

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68577-0188-00 · COSMAX 68577-0190-00 · COSMAX →
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.