Home › NDC Lookup › Ingredients › Body Cleanser › 68599-0212-08
🧴image loading
(from DailyMed)

Dimethicone Body Cleanser 17.5 ug/mg Liquid, 237 mg

by McKesson · 237 mg in 1 BOTTLE (68599-0212-8)
NDC 68599-0212-08
🏷️ FDA NDC (as labeled) 68599-0212-8 billing pads the package 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 →

🆔 Identity & classification

FDA NDC (as labeled) 68599-0212-8
Product NDC 68599-0212
11-digit billing NDC 68599021208
UNII 92RU3N3Y1O
UPC 0612479220324
Application # M016
SPL Set ID 8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a8
Physiologic effect Skin Barrier Activity
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-08-13
Route TOPICAL
Dosage form LIQUID
Substance DIMETHICONE
Why two NDCs? The FDA registers this code as 68599-0212-8 — 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 → 68599-0212-08. 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

LabelerMcKesson
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code68599
First marketedAug 2019
Product typeHuman Otc Drug
Portfolio27 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?

This is a liquid body cleanser applied to the skin that contains dimethicone, a silicone-based ingredient. Dimethicone is commonly used in skin care products as a protective barrier and conditioning agent. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established safety and use guidelines for this category rather than undergoing individual product review.

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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII LP618AV2EA
    A natural oil derived from chamomile and other plants. It serves as a fragrance and flavoring agent to improve the taste and smell of the medicine.
  • UNII OF5P57N2ZX
    Alanine is a naturally occurring amino acid used in medicines as a buffering agent and pH stabilizer. It helps maintain the proper acidity level in liquid formulations to improve stability and taste.
  • UNII LU49E6626Q
    A synthetic organic compound used as a pH buffer and neutralizing agent in medicines. It helps maintain the proper acidity level in liquid formulations to improve stability and comfort.
  • UNII 94ZLA3W45F
    Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid formulations.
  • UNII 30KYC7MIAI
    Aspartic acid is an amino acid used in pharmaceutical formulations as a pH buffer and to help stabilize active ingredients. It works to maintain the proper acidity level in the medicine.
  • 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 568ET80C3D
    Calcium pantothenate is a salt form of pantothenic acid, a B-vitamin derivative. It's used as a nutritional supplement or vitamin fortification ingredient in medicines and formulations.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII 59TL3WG5CO
    A synthetic polymer made by crosslinking acrylic acid with allyl sucrose. It thickens liquids, forms gels, and helps control how fast the medicine is released in your body.
  • UNII 9S60Q72309
    A plant-derived ingredient made from safflower seed components. It acts as an emulsifier and carrier to help distribute oils and active ingredients evenly throughout the medicine.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII I670DAL4SZ
    A preservative that fights bacteria and fungi. It keeps medicines and topical products stable and safe from microbial contamination during storage and use.
  • UNII C5529G5JPQ
    Ginger is a plant-derived ingredient used as a flavoring agent to add taste and aroma to medicines. It may also provide mild soothing properties to support product palatability.
  • UNII 3KX376GY7L
    Glutamic acid is an amino acid used in pharmaceuticals as a buffer and pH regulator. It helps maintain the medicine's chemical stability and proper acidity level.
  • 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 FCZ5MH785I
    A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
  • UNII TE7660XO1C
    Glycine is an amino acid used in medicines as a buffer to help stabilize pH and improve taste. It may also serve as a filler or binder to give the product proper form and consistency.
  • UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • UNII 04Y7590D77
    A naturally occurring amino acid used as a buffering agent and pH stabilizer in medications. It helps maintain the chemical balance of the formulation to protect drug stability.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII TP11QR7B8R
    A natural oil extracted from kukui nuts, used as an emollient and skin-conditioning agent in topical medicines. It helps soften the formulation and improve how the product spreads and absorbs into skin.
  • UNII GMW67QNF9C
    Leucine is an amino acid derived from natural sources. It acts as a glidant and flow agent in powders and tablets, helping the medicine move smoothly during manufacturing and packaging.
  • UNII K3Z4F929H6
    Lysine is an amino acid that serves as a buffer and pH regulator in medications. It helps maintain the medicine's stability and proper acidity level 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 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII 12UZE4X73L
    A modified starch derived by chemically treating regular starch with succinic acid. It acts as a thickener, stabilizer, and emulsifier to improve texture and prevent separation in liquid or semi-solid formulations.
  • UNII 276639YRZL
    A synthetic emulsifier derived from sorbitol and polyethylene glycol. It helps mix oil and water-based ingredients in medicines, keeping them blended and stable throughout the product's shelf life.
  • UNII 788QAG3W8A
    A synthetic polymer that combines polyethylene glycol, glycidyl ether, and sodium hyaluronate. It acts as a thickener and film-former in topical products, helping maintain texture and improve how the medicine spreads on skin.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 47E5O17Y3R
    Phenylalanine is an amino acid used as a sweetener and flavor enhancer in medicines and supplements. It helps make products taste better while keeping them shelf-stable.
  • UNII YRC528SWUY
    A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
  • UNII 9DLQ4CIU6V
    Proline is an amino acid used in pharmaceutical formulations as a bulking agent and stabilizer. It helps maintain product stability and can improve the texture or consistency of medicines, particularly in powders and freeze-dried products.
  • UNII 68Y4CF58BV
    Pyridoxine hydrochloride is a form of vitamin B6, added to medicines as a nutritional supplement or to meet dietary requirements. It supports the body's metabolism and nerve function.
  • UNII 65UEH262IS
    Safflower oil is a plant-based oil extracted from safflower seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients, and sometimes as an emollient to improve texture.
  • UNII 452VLY9402
    Serine is an amino acid, a building block of proteins. In medications, it functions as a buffering agent and stabilizer to help maintain the product's pH balance and protect active ingredients during storage.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 836SJG51DR
    Sodium ascorbyl phosphate is a derivative of vitamin C that acts as an antioxidant and preservative in medications. It helps protect the drug's active ingredients from degradation caused by air and light exposure.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 2ZD004190S
    Threonine is an amino acid, a naturally occurring protein building block. It functions as a buffering agent and pH stabilizer in medicines to maintain proper acidity levels and product stability.
  • UNII 42HK56048U
    Tyrosine is an amino acid, a building block of proteins. In medicines, it's used as a buffering agent to help stabilize the product's pH and improve its chemical stability during storage.
  • UNII HG18B9YRS7
    Valine is an amino acid, one of the building blocks of proteins. In medicines, it acts as a filler and bulking agent to give the product proper volume and texture.
  • 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.

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

The official label also statesInactive Ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alanine, Aleurites Moluccana (Kukui) Seed Oil, Aminomethyl Propanol, Arginine, Aspartic Acid, Bisabolol, Butylene Glycol, Calcium Pantothenate (Vitamin B5), Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Carthamus Tinctorius (Safflower) Seed Oil, Ceteareth-20, Cetyl Alcohol, Chlorphenesin, Disodium EDTA, Fragrance, Glutamic Acid, Glycerin, Glyceryl Stearate, Glycine, Histidine, Isoleucine, Isopropyl Myristate, Leucine, Lysine, Maltodextrin, Niacinamide (Vitamin B3), PEG-40 Sorbitan Peroleate, Phenoxyethanol, Phenylalanine, Proline, Pyridoxine HCL (Vitamin B6), Serine, Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Stearic Acid, Threonine, Tocopheryl Acetate (Vitamin E), Tyrosine, Valine, Water, Zingiber Officinale (Ginger) Root Extract

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
Dimethicone 17.5 ug/mgthis 68599-0212-08 McKesson 237 mg — — 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

🏛️
2019
On the market since
Aug 2019
📍
2026
Currently FDA-listed
7 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.

🔬 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 Skin Protectant — the ingredient across all brands.

Top reported reactions

Macular Degeneration462
Pyrexia396
Nausea360
Malaise315
Pain314
Weight Decreased267
Diarrhoea245

Age at onset

Neonate5
Infant10
Child36
Adolescent12
Adult200
Elderly303

Reporter sex

0 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization1,740
Death442
Life-threatening239
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 393 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
68599-0212-08 You're viewing this 237 mg in 1 BOTTLE (68599-0212-8) 2019-08-13 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 68599-0212-8, 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: 68599-0212-08, written without dashes as 68599021208. 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 68599-0212-08, the first segment (68599) is the labeler code FDA assigned to McKesson; the middle segment (0212) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) 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 McKesson. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
McKesson 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 26 words ▾

Uses temporarily protects and helps relieve chapped or cracked skin cleanses, moisturizes, and helps protect skin it can be used on face, body and perineal area

⏱️ Dosage and Administration 28 words ▾

Directions Apply cleanser to damp cloth or to skin/ perineal area and then gently wipe clean No rinsing necessary Apply as needed Apply a protectant cream as necessary

⚠️ Warnings 26 words ▾

Warnings For external use only. When using this product do not get into eyes Do not use on deep or puncture wounds animal bites serious burns

🧪 Active Ingredient 4 words ▾

Active ingredient Dimethicone 1.75%

🧪 Inactive Ingredients 95 words ▾

Inactive Ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alanine, Aleurites Moluccana (Kukui) Seed Oil, Aminomethyl Propanol, Arginine, Aspartic Acid, Bisabolol, Butylene Glycol, Calcium Pantothenate (Vitamin B5), Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Carthamus Tinctorius (Safflower) Seed Oil, Ceteareth-20, Cetyl Alcohol, Chlorphenesin, Disodium EDTA, Fragrance, Glutamic Acid, Glycerin, Glyceryl Stearate, Glycine, Histidine, Isoleucine, Isopropyl Myristate, Leucine, Lysine, Maltodextrin, Niacinamide (Vitamin B3), PEG-40 Sorbitan Peroleate, Phenoxyethanol, Phenylalanine, Proline, Pyridoxine HCL (Vitamin B6), Serine, Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Stearic Acid, Threonine, Tocopheryl Acetate (Vitamin E), Tyrosine, Valine, Water, Zingiber Officinale (Ginger) Root Extract

🎯 Purpose 3 words ▾

Purpose Skin Protectant

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