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PanOxyl Salicylic Acid 20 mg/g Soap, 113 g

by Crown Laboratories · 113 g in 1 CARTON (0316-0288-01)
NDC 00316-0288-01
🏷️ FDA NDC (as labeled) 0316-0288-01 billing pads the labeler 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) 0316-0288-01
Product NDC 0316-0288
11-digit billing NDC 00316028801
NCPDP billing unit EA — each (per item)
RxCUI 312882
UNII O414PZ4LPZ
Application # M006
SPL Set ID 48fd0106-4db4-f33a-e063-6294a90a5a0b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-05
Route TOPICAL
Dosage form SOAP
Substance SALICYLIC ACID
Why two NDCs? The FDA registers this code as 0316-0288-01 — a 4-4-2 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 labeler segment → 00316-0288-01. 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

LabelerCrown Laboratories
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code00316
First marketedJan 2026
Product typeHuman Otc Drug
Portfolio43 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 →

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 K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII 62V75NI93W
    A surfactant derived from coconut oil that helps cleanse and remove oils from skin or hair. In medicines and personal care products, it acts as a cleanser and foaming agent.
  • UNII SL4SX1O487
    A plant-derived polysaccharide used as a binder and thickener in medicines. It helps hold tablet ingredients together and can increase the viscosity of liquid formulations.
  • 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 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII R1TQH25F4I
    Sodium cocoate is a salt derived from coconut oil. It acts as an emulsifier and surfactant in medicines, helping to mix ingredients that normally don't blend together and improve product texture and stability.
  • UNII R6Q3791S76
    Sodium gluconate is a salt derived from gluconic acid, a naturally occurring compound. In medicines, it functions as a buffering agent to help maintain stable pH and as a chelating agent that can bind minerals in formulations.
  • UNII 6H91L1NXTW
    A processed palm kernel oil derivative used as an emulsifier and surfactant in medications. It helps mix oil and water-based ingredients together and improves how the medicine spreads and dissolves in the body.
  • UNII S0A6004K3Z
    Sodium palmate is a salt made from palm oil. It acts as an emulsifier and surfactant in medicines, helping mix ingredients that normally don't blend well together and improving product texture and consistency.
  • UNII MP1J8420LU
    A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
  • 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 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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 C32PQ86DH4
    Zinc PCA is a zinc salt of pyroglutamic acid, a naturally occurring amino acid derivative. It's used in medications as a skin-conditioning agent and to help maintain product stability and texture in topical formulations.

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

The official label also statesAqua, Butyrospermum Parkii (Shea Butter), Cocamidopropyl Hydroxysultaine, Galactoarabinan, Glycerin, Mandelic Acid, Sodium Chloride, Sodium Cocoate*, Sodium Gluconate, Sodium Palm Kernelate*, Sodium Palmate, Tetrasodium EDTA, Tetrasodium Glutamate Diacetate, Titanium Dioxide (CI 77891), Zinc PCA *contains one or more of these ingredients

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 eachPer 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
PanOxyl 20 mg/gthis 00316-0288-01 Crown 113 g — — FDA listed —
Asepxia Charcoal Acne Bar 2 g/100g 50066-0801-01 Genomma 1 applicator — — FDA listed —
Asepxia Neutral Acne Bar 2 g/100g 50066-0802-01 Genomma 1 applicator — — FDA listed —
Asepxia Oil-Free Acne Bar 2 g/100g 50066-0803-01 Genomma 1 applicator — — FDA listed —
Asepxia Scrub Acne Bar 2 g/100g 50066-0804-01 Genomma 1 applicator — — FDA listed —
Asepxia Softening Acne Bar 2 g/100g 50066-0805-01 Genomma 1 applicator — — FDA listed —
Axe 2 g/100g 64942-2025-01 Conopco 127.5 g — — FDA listed —
Blemish Control Bar 2 g/100g 68726-0439-01 CP 1 jar — — FDA listed —
Defense Acne Care 2% Salicylic Acid 2 g/100g 70856-3582-00 Defense 119 g — — FDA listed —
111MedCo 2% Salicylic Acid Cleansing Bar 20 mg/g 72811-0000-04 111MedCo 113 g — — FDA listed —
Sulfur 8 Fresh Anti-Dandruff Hair and Scalp Conditioner 20 mg/g 12022-0026-00 J. 108 g — — FDA listed —
CeraVe Developed with Dermatologists Psoriasis Moisturizing 20 mg/g 49967-0701-01 L'Oreal 227 g — — FDA listed —
Equate Beauty Medicated Apricot Cleanser Acne Medication 20 mg/g 79903-0323-06 WALMART 170 g — — FDA listed —
Medicated Apricot Scrub 20 mg/g 49035-0003-30 Walmart 170 g — — FDA listed —
Medicated Apricot Scrub 20 mg/g 55910-0034-30 Old 170 g — — FDA listed —
Medicated Apricot Scrub 20 mg/g 56062-0003-30 Publix 170 g — — FDA listed —
DermaD ATOPIC DERMATITIS Therapeutic 20 mg/g 70794-0101-28 Chen 81 g — — FDA listed —
Medicated Apricot Scrub 20 mg/g 41163-0041-30 United 170 g — — FDA listed —
Meijer Blackhead Clearing Scrub Acne medication 20 mg/g 41250-0879-01 Meijer 141 g — — FDA listed —
DermaER Psoriasis Therapeutic 20 mg/g 70794-0207-14 Chen 50 g — — FDA listed —
DermaD Psoriasis Therapeutic 20 mg/g 70794-0261-25 Chen 81 g — — FDA listed —
DermaD ANTIFUNGAL Therapeutic 20 mg/g 70794-0708-85 Chen 81 g — — FDA listed —
Clean and Clear acne triple clear exfoliating scrub 20 mg/g 69968-0013-05 Kenvue 141 g — — FDA listed —
Neutrogena Oil-Free Acne Wash Cream Cleanser 20 mg/g 69968-0940-06 Kenvue 189 g — — FDA listed —
Medicated Apricot Scrub 20 mg/g 72476-0044-30 Retail 170 g — — FDA listed —
Blackhead Clearing Scrug 20 mg/g 49035-0301-56 Walmart 141 g — — FDA listed —
pHisoderm Clear Confidence Face Scrub 20 mg/g 10742-1233-01 The 142 g — — FDA listed —
Asepxia Acne Treatment 20 mg/g 50066-0064-01 Genomma 1 tube — — FDA listed —
DermaD JOCK ITCH Therapeutic 20 mg/g 70794-0201-82 Chen 81 g — — FDA listed —
pHisoderm CLEAN ANTI-BLEMISH BODY WASH 20 mg/g 10742-1236-01 The 5 g — — FDA listed —
Medicated Apricot Scrub 20 mg/g 36800-0009-30 Topco 170 g — — FDA listed —
Dermaclear Mask 20 mg/g 62742-4074-02 Allure 1 tube — — FDA listed —
Neutrogena Oil-Free Acne Stress Control Power-Cream Wash 20 mg/g 69968-0941-06 Kenvue 172 g — — FDA listed —
DermaD ANTI-ITCH Therapeutic 20 mg/g 70794-0313-94 Chen 81 g — — FDA listed —
Viaderma Clear Acne Treatment 20 mg/g 71262-0016-15 ViaDerma 1 bottle — — FDA listed —
OXY Volcanic Clay Acne Wash 20 mg/g 10742-8338-01 The 142 g — — FDA listed —
Natureplex Psoriasis 20 mg/g 67234-0073-01 Natureplex, 1 tube — — FDA listed —
amazon basics acne blackhead clearing scrub Acne Treatment 20 mg/g 72288-0862-01 AMAZON.COM 142 g — — FDA listed —
ULTA All Clear SERUM 20 mg/g 79959-0011-01 APR 1 tube — — FDA listed —
Phisoderm Anti-Blemish Gel Cleanser 20 mg/g 10742-8417-01 The 177 g — — FDA listed —
Medicated Apricot Scrub 20 mg/g 41250-0007-30 Meijer, 170 g — — FDA listed —
Clean and Clear blackhead eraser scrub 20 mg/g 69968-0234-05 Kenvue 141 g — — FDA listed —
Clean and Clear Acne Spot Treatment 20 mg/g 69968-1016-01 Kenvue 1 tube — — FDA listed —
Drs. ACNE SPOT TREATMENT 20 mg/g 80489-0357-01 OL 1 tube — — 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

🏛️
2026
On the market since
Jan 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 PanOxyl (this brand).

Top reported reactions

Dry Skin864
Condition Aggravated634
Rash586
Acne562
Skin Burning Sensation519
Erythema506
Skin Irritation502

Age at onset

Neonate8
Infant1
Child26
Adolescent50
Adult440
Elderly122

Reporter sex

8,339 reports
Male · 35%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization991
Death672
Life-threatening238
Disabling181
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,040 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
00316-0288-01 You're viewing this 113 g in 1 CARTON (0316-0288-01) 2026-01-05 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 0316-0288-01, 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: 00316-0288-01, written without dashes as 00316028801. 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 00316-0288-01, the first segment (00316) is the labeler code FDA assigned to Crown Laboratories; the middle segment (0288) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Crown Laboratories. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Crown Laboratories 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 6 words ▾

Use for the treatment of acne

⏱️ Dosage and Administration 74 words ▾

Directions wet face and work product into a lather cover the entire affected area with a thin layer one to three times daily rinse thoroughly and pat dry 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 70 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 acne medication at a time. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 21 words ▾

Other information Store at 20 o - 25 o C (68 o - 77 o F) [see USP Controlled Room Temperature].

🧪 Active Ingredient 5 words ▾

Active ingredient Salicylic Acid 2%

🧪 Inactive Ingredients 42 words ▾

Inactive ingredients Aqua, Butyrospermum Parkii (Shea Butter), Cocamidopropyl Hydroxysultaine, Galactoarabinan, Glycerin, Mandelic Acid, Sodium Chloride, Sodium Cocoate*, Sodium Gluconate, Sodium Palm Kernelate*, Sodium Palmate, Tetrasodium EDTA, Tetrasodium Glutamate Diacetate, Titanium Dioxide (CI 77891), Zinc PCA *contains one or more of these ingredients

🎯 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 ↗
← 00316-0286-01 · Crown 00316-0296-04 · Crown →
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.