HomeNDC LookupIngredientsSalicylic Acid › 68479-0350-00
Acne Biotic Moisturizer Salicylic Acid .5 mg/100mL Lotion, 2 mL — NDC 68479-0350-00 package photo

Acne Biotic Moisturizer Salicylic Acid .5 mg/100mL Lotion, 2 mL

by Dermalogica, LLC. · 2 mL in 1 POUCH (68479-350-00)
NDC 68479-0350-00
🏷️ FDA NDC (as labeled) 68479-350-00 billing pads the product segment with a zero
This package
Contains2 mL Pack sizes3 compare ↓
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) 68479-350-00
Product NDC 68479-350
11-digit billing NDC 68479035000
UNII O414PZ4LPZ
Application # M006
SPL Set ID ee181358-7f51-413f-9f6b-27ce9778bd07
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-02-01
Route TOPICAL
Dosage form LOTION
Substance SALICYLIC ACID
Why two NDCs? The FDA registers this code as 68479-350-00 — 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 → 68479-0350-00. 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

LabelerDermalogica, LLC.
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code68479
First marketedFeb 2025
Product typeHuman Otc Drug
Portfolio17 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 topical lotion containing salicylic acid, an over-the-counter skin care product marketed under FDA's OTC monograph rules for acne treatments. Salicylic acid is commonly used to help soften and remove dead skin cells, which is the typical way this type of ingredient addresses acne-prone skin. The lotion form allows the active ingredient to be applied directly to affected areas of the skin.

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 Q7UI015FF9
    A synthetic polymer material used as a thickener and stabilizer in liquid formulations. It helps create the right texture and prevents separation of ingredients in medicines and topical products.
  • UNII KM66971LVF
    A spice derived from peppercorn plants, used as a flavoring agent and potential natural preservative in some formulations to enhance taste and mask unwanted flavors in medicines.
  • 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 OBL58JN025
    Octanoic acid is a fatty acid used as a solvent and surfactant in medicines. It helps dissolve active ingredients and improve how the body absorbs them.
  • 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 58B69Q84JO
    A plant-derived emulsifier made from olive oil and fatty alcohols. It helps blend oil and water ingredients together and stabilizes the product's texture in creams, lotions, and similar formulations.
  • 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 87L0D4U3M0
    A plant oil derived from clary sage flowers. It's used as a fragrance and flavoring agent in medicines to improve taste and aroma.
  • UNII JXN40O9Y9B
    A synthetic antimicrobial agent used as a preservative in liquid medicines and topical products. It helps prevent bacterial and fungal growth to maintain product stability and safety during storage.
  • UNII RA96B954X6
    Erythritol is a sugar alcohol derived from fermented fruits or grains. It's used as a sweetener and bulking agent in medicines to improve taste without adding significant calories.
  • UNII HTC7G3S2PV
    Ethylhexyl olivate is an emollient and skin-conditioning agent derived from olive oil. It helps soften the product's texture and improves how the medicine spreads or absorbs on skin or mucous membranes.
  • 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 JOS53KRJ01
    Inulin is a fiber derived from plants like chicory root. It acts as a filler and binder in medicines to add bulk and help hold tablets together.
  • UNII 9RES347CKG
    A fragrant oil derived from lavandin plants, used as a flavoring and aromatic agent to improve the taste and smell of medicines.
  • UNII ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII ET5GD00TRP
    A natural oil extracted from lemon peel used as a flavoring agent and fragrance in medicines. It masks bitter tastes and adds pleasant lemon flavor to make medications easier to take.
  • UNII 5M609NV974
    A plant extract from magnolia bark used as a natural flavoring agent and preservative in medicines. It may help mask bitter tastes and protect the product from spoilage.
  • UNII M6QU9ZUH2X
    A natural essential oil derived from the Manuka tree, used in medicines as a fragrance, flavor enhancer, and preservative to improve product appeal and shelf stability.
  • 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 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 7829X3G2X5
    A plant extract from the morinda citrifolia fruit, used as a natural flavoring agent and colorant in medicines. It may also provide antioxidant properties to help preserve the product's stability.
  • UNII 461N1O614Y
    A synthetic oily liquid used as an emollient and solvent in medications. It helps dissolve active ingredients and improves how the medicine spreads or absorbs through the skin.
  • UNII Y5W63E7HLV
    A type of brown algae used as a natural colorant and nutritional ingredient in medicines and supplements. It may serve as a filler or source of beneficial compounds in formulations.
  • UNII 3N8LGV97HR
    A synthetic polymer used as a film-former and suspending agent. It helps create a protective coating on tablets or capsules and keeps particles evenly distributed in liquid formulations.
  • UNII CH428W5O62
    A plant-derived emulsifier made from jojoba oil that has been chemically broken down and converted to potassium salts. It helps mix oil and water-based ingredients together in the formulation and improves product texture and stability.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • UNII 8LGU7VM393
    Rosemary leaf oil is a natural aromatic oil extracted from rosemary plants. It's used in medicines as a flavoring agent and preservative to help protect the product from spoilage.
  • 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 MDL271E3GR
    Sorbitan olivate is an emulsifier derived from sorbitol and olive oil. It helps blend water and oil ingredients together to maintain consistent texture and appearance throughout the medicine.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII 5EHL50I4MY
    A sodium salt compound used as a chelating agent in medicines. It binds to metals and minerals to improve stability, prevent discoloration, and help the medication stay effective longer.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling 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.
  • UNII VCQ006KQ1E
    Xylitol is a naturally occurring sugar alcohol derived from plants. It's used in medicines as a sweetener, bulking agent, and to improve taste, especially in liquid formulations and chewable tablets.

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

The official label also statesWater/Aqua/Eau, Butylene Glycol, Propanediol, Niacinamide, Octyldodecanol, Ethylhexyl Olivate, Glycerin, Erythritol, Inulin, Cetearyl Olivate, Lavandula Angustifolia (Lavender) Oil, Lavandula Hybrida Oil, Citrus Limon (Lemon) Peel Oil, Salvia Sclarea (Clary) Oil, Hydrolyzed Jojoba Esters, Morinda Citrifolia Fruit Extract, Leptospermum Scoparium Branch/Leaf Oil, Phaeodactylum Tricornutum Extract, Magnolia Officinalis Bark Extract, Piper Nigrum (Pepper) Seed Extract, Rosmarinus Officinalis (Rosemary) Leaf Oil, Tocopherol, Xylitol, Squalane, Caprylyl Glycol, Lecithin, Glutamic Acid, Polyquaternium-80, Didecyldimonium Chloride, Methylpropanediol, Sorbitan Olivate, Tetrasodium Glutamate Diacetate, Citric Acid, Sodium Hydroxide, Polyacrylate Crosspolymer-6, Caprylic Acid, Linalool, Limonene.

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 DailyMedingredient 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 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: 50 mL 7 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Proactiv Advanced Daily Oil Control .5 mg/100mL 11410-0055-00 Alchemee, 1 tube FDA listed
Acne Biotic Moisturizer .5 mg/100mLthis 68479-0350-00 Dermalogica, 2 ml FDA listed
Salicylic Acid 0.5% Body Serum .5 mg/100mL 72208-0321-01 Deciem 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

🏛️
2025
On the market since
Feb 2025
📍
2026
Currently FDA-listed
1 year 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 Salicylic Acid — the ingredient across all brands.

Top reported reactions

Dry Skin12,766
Erythema12,318
Acne11,763
Skin Burning Sensation11,557
Skin Irritation7,730
Skin Exfoliation5,759
Rash4,766

Age at onset

Neonate7
Infant1
Child16
Adolescent30
Adult334
Elderly131

Reporter sex

52,595 reports
Male · 27%
Female · 73%
Unknown · 0%

Serious outcomes

Hospitalization800
Death632
Life-threatening214
Disabling147
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 18,985 111
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
68479-0350-00 You're viewing this 2 mL in 1 POUCH (68479-350-00) 2025-02-01 Active
68479-0350-02 1 BOTTLE in 1 CARTON (68479-350-02) / 50 mL in 1 BOTTLE 2025-02-01 Active
68479-0350-05 1 BOTTLE in 1 CARTON (68479-350-05) / 7 mL in 1 BOTTLE 2025-02-01 Active

Pack size FAQ

What quantity is in NDC 68479-0350-00?
NDC 68479-0350-00 contains 2 mL — 2 ml in 1 pouch.
What NDC number is used to bill for this package of Acne Biotic Moisturizer Salicylic Acid .5 mg/100mL Lotion?
Bill NDC 68479-0350-00 — the 11-digit billing format is 68479035000. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 68479-350-00, 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: 68479-0350-00, written without dashes as 68479035000. 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 68479-0350-00, the first segment (68479) is the labeler code FDA assigned to Dermalogica, LLC.; the middle segment (0350) 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 Dermalogica, LLC.. 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 2 other package presentations of this same product, including 1 bottle (68479-0350-02), 1 bottle (68479-0350-05). 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?
Dermalogica, LLC. 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 6 words

Use For the treatment of acne

⏱️ Dosage and Administration 69 words

Directions Clean the 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 86 words

Warnings For external use only Do not use In or near eyes. If contact occurs, flush thoroughly with water. If irritation or redness develops, discontinue use.

When using this product Apply to affected areas only. Skin irritation and dryness are 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.

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

🧪 Active Ingredient 5 words

Active Ingredients Salicylic Acid (0.5%)

🧪 Inactive Ingredients 86 words

Inactive Ingredients Water/Aqua/Eau, Butylene Glycol, Propanediol, Niacinamide, Octyldodecanol, Ethylhexyl Olivate, Glycerin, Erythritol, Inulin, Cetearyl Olivate, Lavandula Angustifolia (Lavender) Oil, Lavandula Hybrida Oil, Citrus Limon (Lemon) Peel Oil, Salvia Sclarea (Clary) Oil, Hydrolyzed Jojoba Esters, Morinda Citrifolia Fruit Extract, Leptospermum Scoparium Branch/Leaf Oil, Phaeodactylum Tricornutum Extract, Magnolia Officinalis Bark Extract, Piper Nigrum (Pepper) Seed Extract, Rosmarinus Officinalis (Rosemary) Leaf Oil, Tocopherol, Xylitol, Squalane, Caprylyl Glycol, Lecithin, Glutamic Acid, Polyquaternium-80, Didecyldimonium Chloride, Methylpropanediol, Sorbitan Olivate, Tetrasodium Glutamate Diacetate, Citric Acid, Sodium Hydroxide, Polyacrylate Crosspolymer-6, Caprylic Acid, Linalool, Limonene.

🎯 Purpose 3 words

Purpose Acne treatment

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.