HomeNDC LookupIngredientsSalicylic Acid › 68726-0445-03
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(from DailyMed)

PCA Gel Salicylic Acid 2 g/100mL Gel, 7.3 mL

by CP Skin Health Group, Inc · 7.3 mL in 1 TUBE (68726-445-03)
NDC 68726-0445-03
🏷️ FDA NDC (as labeled) 68726-445-03 billing pads the product segment with a zero
This package
Contains7.3 mL Pack sizes2 compare ↓
Also comes in: 29.5 mL 68726-0445-02
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) 68726-445-03
Product NDC 68726-445
11-digit billing NDC 68726044503
RxCUI 346298
UNII O414PZ4LPZ
Application # M006
SPL Set ID 396b4675-451f-48b2-b139-19508434e0fe
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-08-01
Route TOPICAL
Dosage form GEL
Substance SALICYLIC ACID
Why two NDCs? The FDA registers this code as 68726-445-03 — 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 → 68726-0445-03. 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.

🏷️ RxNorm drug class

This medicine belongs to the Salicylic acid and derivatives class.

Drug family (ATC) Salicylic acid and derivatives, Other antifungals for topical use, Antiinflammatory agents, non-steroids
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerCP Skin Health Group, Inc
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code68726
First marketedAug 2020
Product typeHuman Otc Drug
Portfolio19 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

📗 Our plain-language guide HelloPharmacist
  • It's designed to treat acne. Salicylic acid helps by loosening and removing dead skin cells that clog pores — the buildup that leads to breakouts. The multi-step system on this lab...
  • What is this salicylic acid product actually supposed to do for my skin?
  • Some mild tingling, stinging, and peeling is actually expected — that's the salicylic acid doing its job by clearing away dead skin cells. But if the burning or peeling feels exces...
  • My skin feels like it's burning and peeling. Is that normal?
📖 Read our full Salicylic Acid Topical guide →
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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • 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 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 4YK5Z54AT2
    Denatonium benzoate is a bitter-tasting chemical compound added to medicines to discourage accidental ingestion, especially by children. It serves as a bittering agent with no therapeutic effect on the body.
  • UNII A1A1I8X02B
    A clear liquid solvent derived from ethylene glycol. It helps dissolve active ingredients and improve how the medicine flows and mixes in liquid formulations.
  • UNII MJ2YTT4J8M
    Ethyl linoleate is a fatty acid ester derived from linoleic acid. It acts as an emollient and solvent in formulations, helping to dissolve or carry active ingredients and improve product texture and absorption.
  • UNII R9QTB5E82N
    Hexylresorcinol is a chemical compound used in medicines as an antimicrobial preservative and antiseptic agent. It helps prevent bacterial growth and keeps the product stable during storage.
  • UNII 19NOL5474Q
    Isopentyldiol is a synthetic alcohol derived from isoprene. It functions as a humectant and solvent in formulations, helping to retain moisture and dissolve or suspend active ingredients.
  • UNII NH496X0UJX
    Mandelic acid is an organic acid derived from almonds. It functions as a buffer and pH adjuster in medications, helping maintain the product's stability and proper acidity level.
  • UNII 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • UNII 84VD0IA2S6
    A plant-derived emulsifier made from glycerin and palmitic acid. It helps blend oil and water-based ingredients together, keeping the medicine uniform and stable.
  • UNII 55C81W76DH
    A synthetic emulsifier made from glycerin and oleic acid (a plant-based oil). It helps blend water and oil-based ingredients together in formulations and improves how the product spreads or absorbs.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII SMD1X3XO9M
    Powdered cellulose is a fine, plant-based powder made from purified wood fibers. In medicines, it acts as a filler to add bulk and volume, and helps tablets or capsules hold together during manufacturing and storage.
  • 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 MD83SFE959
    A volatile organic liquid used as a solvent and preservative in medications. It helps dissolve active ingredients and other components, and can improve product stability and shelf life.
  • 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.

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

The official label also statesAlcohol, Butylene Glycol, Cellulose, Denatonium Benzoate, Ethoxydiglycol, Ethyl Linoleate, Hexylresorcinol, Hydroxyethylcellulose, Isopentyldiol, Mandelic Acid, Pentylene Glycol, Polyacrylate Crosspolymer-6, Polyglyceryl-10 Dioleate, Polyglyceryl-10 Dipalmitate, Potassium Hydroxide, Sodium Acetate, t-Butyl Alcohol, Water

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: 29.5 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
Walgreens Acne Control Gel 20 mg/mL 00363-0269-83 WALGREEN 1 tube FDA listed
Artistry Studio Done With Zit Acne Treatment Clearing Gel 20 mg/mL 10056-0045-00 Access 1 tube FDA listed
Hero Cosmetics Pimple Correct Salicylic Acid Acne Treatment 20 mg/mL 10237-0003-00 Church 1 tube FDA listed
Acne Treatment Gel 20 mg/mL 31720-0301-08 S+ 1 bottle FDA listed
Eradikate Acne Mark Fading 2 g/100mL 43479-0112-51 KATE 1 bottle FDA listed
Clarifying Peel 2 g/100mL 46007-0102-11 Skin 20 ml Discontinued
ACNE SolutionS CLINICAL ADVANCED CLEARING gel 20 mg/mL 49527-0221-01 CLINIQUE 1 bottle Discontinued
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula Cleanser 20 mg/mL 49967-0051-01 L'Oreal 118 ml FDA listed
CeraVe Developed with Dermatologists Acne Control Acne Treatment 20 mg/mL 49967-0172-01 L'Oreal 1 tube FDA listed
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula Balm 20 mg/mL 49967-0530-01 L'Oreal 118 ml FDA listed
Vichy Laboratoires Normaderm Phytoaction Acne Control Daily Moisturizer 20 mg/mL 49967-0606-01 L'Oreal 1 bottle FDA listed
Vichy Laboratoires Normaderm Acne Control Daily Moisturizer 20 mg/mL 49967-0660-01 L'Oreal 1 bottle FDA listed
clear days ahead fast-acting salicylic acid acne spot treatment .3 g/15mL 50184-1020-01 Philosophy 15 ml FDA listed
Dr. Dennis Gross Alpha Beta On the Spot Eliminator 20 mg/mL 51326-0057-01 Topiderm, 1 tube FDA listed
GOODBYE ACNE Complete treatment gel .9638 g/48.19g 54031-0069-01 Peter 48.19 g FDA listed
BRODA Acne .4 g/20g 54111-0112-50 Bentley 20 g FDA listed
XtraCare Deep Cleaning Astringent 5 mg/237mg 57337-0035-01 Rejoice 237 mg FDA listed
Acne Defense Spot Treatment Merle Norman 2 g/100g 57627-0201-02 Merle 1 tube FDA listed
Image Clear Cell Acne Spot Treatment 20 g/1000g 60232-5022-01 Swiss-American 14 g FDA listed
Dry It Out Acne Spot Treatment 2 g/100mL 61197-0122-00 Pacifica 29 ml FDA listed
Gm Collin Puracne 20 mg/mL 64127-0195-01 Laboratoires 1 tube FDA listed
Overnight Clearing 20 mg/mL 68479-0706-00 Dermalogica, 2 ml FDA listed
Milani Erase Base Blemish Control Primer 20 mg/mL 68577-0103-00 Cosmax 1 tube FDA listed
PCA SKIN Intensive Clarity Treatment 2 g/100g 68726-0359-02 CP 1 tube FDA listed
PCA Gel 2 g/100mLthis 68726-0445-03 CP 7.3 ml FDA listed
Spot Stopper Acne Spot Treatment 2 g/100mL 69366-0412-32 The 1 tube FDA listed
First Aid Beauty FAB Acne Spot Treatment 2 g/100mL 69423-0724-22 The 1 tube FDA listed
Vichy Laboratoires Normaderm Phytoaction Acne Control Moisturizer 20 mg/mL 69625-0605-01 COSMETIQUE 1 bottle FDA listed
Vichy Laboratoires Normaderm Acne Control Daily Moisturizer 20 mg/mL 69625-0617-01 Cosmetique 1 bottle FDA listed
Vichy Laboratoires Normaderm Acne Control Moisturizer 20 mg/mL 69625-0661-01 COSMETIQUE 1 bottle FDA listed
CVS Health Advanced Acne Spot Treatment 20 mg/mL 69842-0464-52 CVS 1 tube FDA listed
Neutrogena Rapid Clear Acne Eliminating Spot 20 mg/mL 69968-0472-01 Kenvue 1 tube FDA listed
Clean and Clear Acne Spot Treatment 20 mg/mL 69968-0804-01 Kenvue 1 tube FDA listed
Neutrogena Rapid Clear Acne Eliminating Spot 20 mg/mL 69968-0825-01 Kenvue 1 tube FDA listed
Clean and Clear Acne Spot Treatment 20 mg/g 69968-1016-01 Kenvue 1 tube FDA listed
Treat So Deep Acne-Fighting Treatment 2 g/100mL 70626-0106-15 ASPIRE 1 tube FDA listed
Acne Treatment Maximum Strength 2 g/100g 70631-0358-02 Young 1 tube FDA listed
Acne Spot Treatment 2 g/100mL 70764-0105-51 CONTROL 1 bottle FDA listed
innisfree Gentle Retinol Salicylic Acne Serum 1 g/50mL 71220-0088-02 Innisfree 1 tube FDA listed
Peace Out Acne Moisturizer 20 mg/mL 71494-0008-01 Peace 1 jar FDA listed
Acne Gel Pen 20 mg/mL 71714-0004-01 Tiege 1.3 ml FDA listed
Eradikate Acne Mark Fading 2 g/100mL 72204-0903-02 Rare 1 bottle FDA listed
ULTA All Clear SERUM 20 mg/g 79959-0011-01 APR 1 tube FDA listed
The INKEY List C 50 Serum 20 mg/mL 81136-0020-01 Brand 1 bottle FDA listed
The INKEY List Beta Hydroxy Acid Serum 20 mg/mL 81136-0021-01 Brand 1 bottle FDA listed
Vichy Laboratoires Normaderm Acne Control Daily Moisturizer 20 mg/mL 82046-0617-01 LOreal 1 bottle FDA listed
Curology Acne-Clearing Gel Serum 2 g/100mL 82575-0500-00 Curology, 1 tube FDA listed
Good Molecules Maximum Strength Acne Gel Cream 2 g/100mL 82730-0102-01 Good 1 tube FDA listed
Starface Acne Spot Treatment 20 mg/mL 83171-0003-01 Starface 1 tube FDA listed
Dermacleanse Acne Spot Treatment .02 g/mL 83313-0062-01 ZENMED 30 ml FDA listed
Skinkure Acne Eraser Spot Treatment 20 mg/mL 83865-0100-10 SKINKURE, 30 ml FDA listed
Tula Skincare Clear It Up Acne Clearing and Tone Correcting Gel 2 g/100mL 84126-0121-15 The 1 tube FDA listed
SEYTU Spot 2 g/100mL 84271-0002-00 Omnilife 1 tube FDA listed
Perricone MD Acne Relief Maximum Strength Spot Gel 2 g/100g 84448-0538-14 THG 1 tube FDA listed
Nativae Milia Acne Serum 20 mg/mL 85065-0557-00 CDE 30 ml FDA listed
TRSTAY LUXE Clarifying Acne Repair Serum .02 g/mL 85277-0001-01 Guangdong 1 bottle FDA listed
Duolaq 20 mg/mL 87110-0001-01 METHODIQ 1 bottle FDA listed
HerbaGlow Baiwooxia Anti-Acne Gel 2 g/100g 87351-0087-01 Kungpo 1 jar FDA listed
The Acne Spot Treatment 2 g/100g 87415-0100-04 Spotless, 1 tube FDA listed
Acne Treatment 2 g/100mL 87799-0999-10 Bio 30 ml FDA listed
Cleansing Wipes 2 g/100mL 71613-0001-01 Nextcell 25 applicators FDA listed
Oxygenetix Oxygenating Foundation Acne Control 2 g/100mL 10258-0101-11 COLONIAL 15 ml Discontinued
Pert 2 in 1 Advanced plus 2 g/100mL 81277-0802-13 Sodalis 400 ml FDA listed
Acne Control Face Wash 2 g/100mL 54111-0185-01 Bentley 180 ml FDA listed
Salicylic Wash 2 g/100mL 70764-0102-56 CONTROL 1 bottle FDA listed
Acne Correction Pads 2 g/100mL 72957-0012-01 Private 1 jar FDA listed
Multi-Action Clear - Acne Clearing Treatment 2% Salicylic Acid 2 g/100mL 76147-0301-07 StriVectin 1 tube FDA listed
PanOxyl Acne Gel Wash 2 g/100mL 00316-0299-01 Crown 192 ml FDA listed
Pharma Clear Cleanser 2 g/100mL 67879-0101-11 PHARMAGEL 175 ml FDA listed
Start So Fresh 2 g/100mL 70626-0105-13 ASPIRE 100 ml FDA listed
Good Molecules Acne Foaming Cleanser 2 g/100mL 82730-0100-05 Good 148 ml FDA listed
Acne Toner Serum 2 g/100mL 82870-0003-01 Dime 60 ml FDA listed
Acne Spot Treatment 2 g/100mL 82870-0006-01 Dime 15 ml FDA listed
Acne Control Superclean Body Wash AHA BHA Formula 2 g/100mL 54111-0170-50 Bentley 250 ml FDA listed
Tula Skincare Breakout Star Lightweight Acne Moisturizer 2 g/100mL 84126-0229-15 The 15 ml FDA listed
Perricone MD Acne Relief Maximum Strength Clearing Treatment 2 g/100mL 84448-0301-59 THG 1 bottle FDA listed
Perricone MD Acne Relief Gentle and Soothing Cleanser 2 g/100mL 84448-0539-17 THG 1 tube FDA listed
Clearasil Stubborn Acne Control 5in1 Exfoliating Wash 2 g/100mL 63824-0436-01 Reckitt 200 ml FDA listed
ELF Blemish Control Face Primer Clear 2 g/100mL 76354-0210-10 e.l.f. 30 ml FDA listed
First Aid Beauty Acne Clearing Pads 2 g/100mL 84126-0119-60 The 60 patches FDA listed
Perricone MD Acne Relief Calming and Soothing Clay Mask 2 g/100mL 84448-0955-10 THG 10 ml FDA listed
Proactiv Deep Cleansing Wash 2 g/100mL 11410-0048-05 THE 1 bottle FDA listed
Good Molecules Acne Foaming Cleanser 2 g/100mL 64412-1005-02 Twincraft 1 bottle FDA listed
ELF Clear Blemish Control Face Primer 2 g/100mL 76354-0624-01 e.l.f. 14 ml FDA listed
Ultra Clear Treatment 2 g/100mL 10028-0051-01 ULTRACEUTICALS 50 ml FDA listed
Clear System Clarifying Gel Cleanser 2 g/100mL 54111-0189-20 Bentley 20 ml FDA listed
anna lotan PURIFYING PADS with 2% Salicylic Acid 2 g/100mL 76446-0039-50 Anna 1 jar FDA listed
Acne Control Body Wash 2 g/100mL 54111-0184-01 Bentley 250 ml FDA listed
Clear Exfoliating Solution Paulas Choice 2 g/100mL 56152-5002-01 Cosmetic 118 ml FDA listed
Bha Cleanser 2% 2 g/100mL 61328-0403-01 Skinfix, 30 ml FDA listed
Triderma Psoriasis Control Body Wash 2 g/100mL 10738-0217-63 Genuine 473 ml FDA listed
Proactivplus Pore Clearing Treatment 2 g/100mL 11410-0047-30 Alchemee, 1 tube FDA listed
First Aid Beauty FAB Pharma White Clay Acne Treatment 2 g/100mL 69423-0555-60 The 60 patches FDA listed
ESSENCE BY CATHERINE HINDS PURIFYING PADS with 2% Salicylic Acid 2 g/100mL 76446-0022-50 Anna 1 jar FDA listed
Acne Spot Treatment 2% Bha 2 g/100mL 61328-0404-05 Skinfix, 15 ml FDA listed
Clearasil Rapid Rescue Deep Treatment Wash 2 g/100mL 63824-0432-01 Reckitt 200 ml FDA listed
Good Molecule Maximum Strenght Acne 2 g/100mL 68577-0287-00 COSMAX 1 tube FDA listed
ORLASKIN ACNE Treatment 2 g/100mL 87582-0005-01 Guangzhou 50 ml FDA listed
SUZANOBAGIMD Acne Cleansing Wipes 2 g/100mL 62032-0617-25 Obagi 25 patches 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

🏛️
2020
On the market since
Aug 2020
📍
2026
Currently FDA-listed
6 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 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
Life-threatening214
Disabling147
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 18,985 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
68726-0445-02 1 BOTTLE in 1 CARTON (68726-445-02) / 29.5 mL in 1 BOTTLE (68726-445-01) 2020-08-01 Active
68726-0445-03 You're viewing this 7.3 mL in 1 TUBE (68726-445-03) 2020-08-01 Active

Pack size FAQ

What quantity is in NDC 68726-0445-03?
NDC 68726-0445-03 contains 7.3 mL — 7.3 ml in 1 tube.
What is the difference between NDC 68726-0445-03 and NDC 68726-0445-02?
Both are PCA Gel Salicylic Acid 2 g/100mL Gel — the drug itself is identical. NDC 68726-0445-03 is the 7.3 mL package, while NDC 68726-0445-02 is the 1 bottle package.
What NDC number is used to bill for this package of PCA Gel Salicylic Acid 2 g/100mL Gel?
Bill NDC 68726-0445-03 — the 11-digit billing format is 68726044503. 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 — 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 68726-445-03, 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: 68726-0445-03, written without dashes as 68726044503. 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 68726-0445-03, the first segment (68726) is the labeler code FDA assigned to CP Skin Health Group, Inc; the middle segment (0445) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 CP Skin Health Group, Inc. 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 1 bottle (68726-0445-02). 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?
CP Skin Health Group, 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 17 words

Uses For the treatment of acne Helps keep skin clear of new acne pimples, blackheads or whiteheads

⏱️ 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 61 words

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

🧪 Active Ingredient 8 words

Active Ingredients Salicylic Acid 2% Purpose Acne Treatment

🧪 Inactive Ingredients 31 words

Inactive Ingredients Alcohol, Butylene Glycol, Cellulose, Denatonium Benzoate, Ethoxydiglycol, Ethyl Linoleate, Hexylresorcinol, Hydroxyethylcellulose, Isopentyldiol, Mandelic Acid, Pentylene Glycol, Polyacrylate Crosspolymer-6, Polyglyceryl-10 Dioleate, Polyglyceryl-10 Dipalmitate, Potassium Hydroxide, Sodium Acetate, t-Butyl Alcohol, Water

🎯 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.