Home › NDC Lookup › Ingredients › Salicylic Acid › 82160-0764-01
Derma Pella Acne Wash for Oily Skin Salicylic Acid 5 mg/mL Solution, 150 mL — NDC 82160-0764-01 package photo

Derma Pella Acne Wash for Oily Skin Salicylic Acid 5 mg/mL Solution, 150 mL

by Pella Pharmaceuticals Co. Ltd · 150 mL in 1 BOTTLE, PLASTIC (82160-764-01)
NDC 82160-0764-01
🏷️ FDA NDC (as labeled) 82160-764-01 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ 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

⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 82160-764-01
Product NDC 82160-764
11-digit billing NDC 82160076401
RxCUI 865105
UNII O414PZ4LPZ
Application # M006
SPL Set ID fe667ac6-4605-0670-e053-6294a90aa1b8
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2023-05-16
Route TOPICAL
Dosage form SOLUTION
Substance SALICYLIC ACID
GCN Seq No 085668
GCN 55204
HICL code 002465
Ingredient (HICL) Salicylic Acid
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5A
Therapeutic class — specific (HIC3) Keratolytics
AHFS code 84:28.00.00
AHFS class Keratolytic Agents
FDB label name DERMA PELLA ACNE WASH 5 MG/ML
FDB brand name Derma Pella Acne Wash
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 82160-764-01 — 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 → 82160-0764-01. 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

LabelerPella Pharmaceuticals Co. Ltd
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code82160
First marketedMay 2023
Product typeHuman Otc Drug
Portfolio3 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

Label name DERMA PELLA ACNE WASH 5 MG/ML Ingredient Salicylic Acid
📖 What it is MedlinePlus · NLM

Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or b...

Read the full MedlinePlus article ↗
📗 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 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII 6PU1E16C9W
    Bronopol is a synthetic antimicrobial preservative used in liquid and semi-solid medicines to prevent the growth of bacteria and fungi, helping keep the product safe and stable throughout its shelf life.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 5OCF3O11KX
    A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
  • UNII 8NLQ36F6MM
    Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
  • 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 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 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII O9W3D3YF5U
    A synthetic surfactant derived from petroleum-based olefins. It helps dissolve or suspend active ingredients and other substances in liquid formulations, improving how the medicine mixes and flows.
  • 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.

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

The official label also statesAqua, Glycerin, Cocamidopropyl Betain, Sodium C14-16 Olefin Sulfonate, Butylene Glycol, Polysorbate 20, Sodium Benzoate, Allantoin, Potassium Sorbate, Disodium EDTA, Parfum, Citric Acid, 2-Bromo-2-Nitropropane-1,3-Diol, Tetrasodium EDTA, Bacillus Ferment

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
Ultra Clear Foaming Cleanser .5 g/100mL 10028-0050-01 ULTRACEUTICALS 150 ml — — FDA listed —
UNBLEMISH Refining Acne Wash .005 g/mL 14222-2111-01 Rodan 1 tube — — FDA listed —
Meijer Foaming Cleanser Acne medication 5 mg/mL 41250-0354-01 Meijer 177 ml — — FDA listed —
Deep Cleaning Astringent 5 mg/mL 41250-0775-34 Meijer, 237 ml — — Discontinued —
Vichy Laboratoires Normaderm Daily Gentle Cleanser 5 mg/mL 49967-0232-01 L'Oreal 125 ml — — FDA listed —
Vichy Laboratoires Normaderm Phytoaction Daily Deep Cleansing 5 mg/mL 49967-0307-01 L'Oreal 200 ml — — FDA listed —
Vichy Laboratoires Normaderm Daily Deep Cleansing Acne Treatment 5 mg/mL 49967-0630-01 L'Oreal 200 ml — — FDA listed —
Salicylic Acid Cleanser 5 mg/mL 54111-0171-02 Bentley 1 tube — — FDA listed —
Purifying Clay Mask .5 g/100mL 56152-5012-01 Cosmetic 88 ml — — FDA listed —
ageLOC LumiSpa Treatment Cleanser Acne 5 mg/mL 62839-1495-01 NSE 100 ml — — FDA listed —
Clear Smart Charcoal Blackhead Scrub .5 g/100mL 68828-0001-01 Distribuidora 1 tube — — FDA listed —
Cln Acne Cleanser 5 mg/mL 69530-0857-46 TopMD 100 ml — — FDA listed —
Vichy Laboratoires Normaderm Phytoaction Deep Cleansing 5 mg/mL 69625-0306-01 COSMETIQUE 200 ml — — FDA listed —
Vichy Laboratoires Normaderm Daily Deep Cleansing Acne Treatment 5 mg/mL 69625-0630-01 COSMETIQUE 200 ml — — FDA listed —
Skinpharmacy Advanced Acne Therapy Pore Refining Facial Mask 5 mg/mL 69842-0077-01 CVS 1 tube — — FDA listed —
Aveeno CLEAR COMPLEXION foaming cleanser 5 mg/mL 69968-0471-06 Kenvue 177 ml — — FDA listed —
Neutrogena deep clean purifying cooling gel scrub 5 mg/g 69968-0740-04 Kenvue 119 g — — FDA listed —
Aveeno Positively Radiant Clear Complexion Foaming Cleanser 5 mg/mL 69968-0769-06 Kenvue 177 ml — — FDA listed —
Clarifying Cleanser .5 g/100mL 70381-0128-02 Murad, 1 tube — — FDA listed —
So Totally Clean Deep Pore Cleanser .5 g/100mL 70626-0104-21 ASPIRE 200 ml — — FDA listed —
Clean Getaway Bag 70626-0504-54 ASPIRE 1 kit — — FDA listed —
MDacne Customized Acne Cleanser Hydrating Salicylic Acid 5 mg/mL 71804-0534-00 MDAlgorithms 59 ml — — FDA listed —
Salicylic Acid Cleanser 5 mg/g 73318-7001-02 Skin 1 bottle — — FDA listed —
Even and Clear Cleanser 5 mg/mL 73453-0003-01 Ambi 177 ml — — FDA listed —
Peach and Lily Peaches Slices Acne Oil Acne Free Moisturizer 5 mg/mL 81515-0502-01 Peach 80 ml — — FDA listed —
Caring Mill Acne Clearing Cleanser .5 g/100mL 81522-0100-01 FSA 250 ml — — FDA listed —
Derma Pella Acne Wash for Oily Skin 5 mg/mLthis 82160-0764-01 Pella 150 ml — — Discontinued —
Creamy Foam Cleanser .5 g/100mL 82870-0002-01 Dime 120 ml — — FDA listed —
Freshiny Facial Cleanser Acne Treatment 5 mg/g 84544-0001-01 Guangdong 1 tube — — FDA listed —
Cetaphil Gentle Clear Triple-Action Acne Serum 5 mg/mL 00299-4135-00 Galderma 1 tube — — FDA listed —
La Roche Posay Laboratoire Dermatologique Effaclar Clarifying 5 mg/mL 49967-0024-01 L'Oreal 200 ml — — FDA listed —
SkinCeuticals Silymarin CF Acne Treatment 5 mg/mL 49967-0068-01 L'Oreal 1 bottle — — FDA listed —
Dr. C. Tuna Acne Pore Purifying Toner 5 mg/mL 74690-0009-01 Farmasi 1 bottle — — FDA listed —
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M MultiTarget Acne Treatment 5 mg/mL 82046-0058-01 L'Oreal 15 tubes — — FDA listed —
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M MultiTarget Acne Treatment 5 mg/mL 69625-0058-01 COSMETIQUE 15 tubes — — FDA listed —
SkinCeuticals Silymarin CF Acne Treatment Antioxidant 5 mg/mL 69625-0069-01 Cosmetique 1 bottle — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Nude 40 5 mg/mL 69968-0856-01 Kenvue 30 ml — — FDA listed —
Nutricentials Here You Glow Exfoliating Toner 5 mg/mL 62839-1339-01 NSE 150 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Buff 30 5 mg/mL 69968-0855-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Caramel 105 5 mg/mL 69968-0864-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Honey 85 5 mg/mL 69968-0861-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Chestnut 135 5 mg/mL 69968-0866-01 Kenvue 30 ml — — FDA listed —
Even Better Clinical Acne Solutions 5 mg/mL 49527-0114-01 CLINIQUE 1 bottle — — FDA listed —
Up and Up Deep Clean Toner 5 mg/mL 11673-0936-11 TARGET 236.5 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Classic Ivory 10 5 mg/mL 69968-0853-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Warm Beige 90 5 mg/mL 69968-0862-01 Kenvue 30 ml — — FDA listed —
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne Treatment 5 mg/mL 49967-0926-01 L'Oreal 1 tube — — FDA listed —
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne Treatment 5 mg/mL 69625-0926-01 COSMETIQUE 1 tube — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup- Medium Beige 80 5 mg/mL 69968-0860-01 Kenvue 30 ml — — FDA listed —
ACNE solutions liquid MAKEUP SALICYLIC ACID ACNE TREATMENT 5 mg/mL 49527-0751-01 CLINIQUE 1 bottle — — Discontinued —
Neutrogena SkinClearing Oil-Free Makeup - Soft Beige 50 5 mg/mL 69968-0857-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Natural Beige 60 5 mg/mL 69968-0858-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Cocoa 115 5 mg/mL 69968-0865-01 Kenvue 30 ml — — FDA listed —
Oxy Total Care Vitamin C Serum 5 mg/mL 10742-1315-01 The 1 vial — — FDA listed —
Breakout Clearing Foaming Wash 5 mg/mL 68479-0101-00 Dermalogica 2 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Natural Ivory 20 5 mg/mL 69968-0854-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Fresh Beige 70 5 mg/mL 69968-0859-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup- Natural Tan 100 5 mg/mL 69968-0863-01 Kenvue 30 ml — — 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

🏛️
2023
On the market since
May 2023
📍
2026
Currently FDA-listed
3 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

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
2021 2022 2024 2026 9,183 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
82160-0764-01 You're viewing this 150 mL in 1 BOTTLE, PLASTIC (82160-764-01) 2023-05-16 Inactivated by FDA

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 82160-764-01, 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: 82160-0764-01, written without dashes as 82160076401. 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 82160-0764-01, the first segment (82160) is the labeler code FDA assigned to Pella Pharmaceuticals Co. Ltd; the middle segment (0764) 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.
Who lists this product with the FDA?
Pella Pharmaceuticals Co. Ltd 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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 📦 How Supplied / Storage and Handling 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📋 Description
🎯 Indications and Usage 29 words ▾

Indications Non-irritating foaming cleanser formulated for acne-prone skins, helps gently exfoliate skin without over drying, deep cleans pores control excess oil, unclog pores and prevent new acne from forming.

⏱️ Dosage and Administration 61 words ▾

Dosage and Administration - Use it twice a day, morning and night. - Pump 2 - 3 times onto the tips of your fingers. - Massage gently over wet skin in a circular motion for 1 min, avoiding eye area. - Rinse thoroughly, pat skin dry. - Follow with non comedogenic moisturizer. - If excessive dryness or peeling occurs, reduce usage.

⛔ Contraindications 7 words ▾

Contraindications Hypersensitivity to any of the components.

⚠️ Warnings 37 words ▾

Warnings - For external use only. - Discontinue if excessive skin irritation develops or increases. If irritation persists, consult with a physician or pharmacist. - Avoid direct contact with eyes, if contact occurs, rinse thoroughly with water.

🤒 Adverse Reactions 14 words ▾

Side Effects It is well tolerated product but mild irritation, dryness, redness may occur.

📦 How Supplied / Storage and Handling 8 words ▾

Forms and Presentation Solution: Plastic Bottle, 150 ml

📦 Storage and Handling 7 words ▾

Storage Conditions Store below 30 ◦ C.

🧪 Active Ingredient 4 words ▾

Active Ingredient Salicylic Acid

🧪 Inactive Ingredients 29 words ▾

Inactive Ingredients Aqua, Glycerin, Cocamidopropyl Betain, Sodium C14-16 Olefin Sulfonate, Butylene Glycol, Polysorbate 20, Sodium Benzoate, Allantoin, Potassium Sorbate, Disodium EDTA, Parfum, Citric Acid, 2-Bromo-2-Nitropropane-1,3-Diol, Tetrasodium EDTA, Bacillus Ferment

🎯 Purpose 6 words ▾

Purpose Facial Cleanser for Oily Skin

📋 Description 124 words ▾

Properties A lightweight, translucent, water-based Alcohol and Sulfate free facial foaming cleanser. This product contains a beta hydroxyl acid (BHA) which is a salicylic acid that helps remove dead skin cells, reduce blackheads and the appearance of pores, so it prevents acne. And also it contains Bacillus Ferment which is a multifunctional biotechnological ingredient obtains from microorganism isolated from natural clay, offers a cleaner smother and more beautiful skin by: - P. acne biofilm inhibition. - Reduced inflammatory response to P. acne. - Skin regenerating effect. - Cleansing activity. - Antioxidant response determined by reactive oxygen species (ROS).

Also it contains Allantoin which is an effective moisturizing ingredient used for it is gentle and non-irritating qualities. Paraben free, Alcohol free, SLS free, SLES free.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 82160-0726-01 · Pella 82168-0001-01 · Guangzhou →
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.