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La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M MultiTarget Acne Treatment Salicylic acid 5 mg/mL Liquid — NDC 69625-058-01 (Billing 69625-0058-01)

by COSMETIQUE ACTIVE PRODUCTION · 15 TUBE in 1 CARTON / 3 mL in 1 TUBE

This is a package of La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M MultiTarget Acne Treatment Salicylic acid 5 mg/mL Liquid from COSMETIQUE ACTIVE PRODUCTION, marketed since Jun 2026 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 69625-0058-01
🏷️ FDA NDC (as labeled) 69625-058-01 billing pads the product segment with a zero
This package
Contains3 mL in 1 tube Pack sizes2 compare ↓
Main listing for product 69625-058 · Also comes in: 40 mL 69625-058-02
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69625-058-01
Product NDC 69625-058
11-digit billing NDC 69625005801
RxCUI 199308
UNII O414PZ4LPZ
UPC 3337875926058, 3337875926065
Application # M006
SPL Set ID 54650326-1582-26b7-e063-6394a90a575c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-06-16
Route TOPICAL
Dosage form LIQUID
Substance SALICYLIC ACID
Quick answers
  • RxCUI (RxNorm): 199308
Why two NDCs? The FDA registers this code as 69625-058-01 — 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 → 69625-0058-01. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It is used in a facial routine for acne-prone and oil-prone skin. The routine includes a cleanser, serum, toner and emulsion. Salicylic acid helps loosen and shed dead skin cells.
  • Use the cleanser morning and evening, and the serum in the morning after cleansing. Use the toner in the evening on dry skin, and the emulsion at night after cleansing. Avoid your...
  • Mild stinging, burning, itching, dryness and extra peeling can happen. If dryness or peeling bothers you, try using the serum or toner every other day. If it gets excessive, stop a...
  • It is best not to. Using another topical acne medication at the same time makes irritation and dryness more likely. If you get irritated, use only one at a time.
📖 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.

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.
Try another pack size: 40 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
69625-0058-01 You're viewing this Main listing 15 TUBE in 1 CARTON / 3 mL in 1 TUBE 2026-06-16 — Active
69625-0058-02 69625-058-02 1 TUBE in 1 CARTON / 40 mL in 1 TUBE 2026-06-16 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 15 tube in 1 carton / 3 ml in 1 tube.
What NDC number is used to bill for this package of La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M MultiTarget Acne Treatment Salicylic acid 5 mg/mL Liquid?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cetaphil Gentle Clear Triple-Action Acne Serum 5 mg/mL 00299-4135-00 Galderma 1 tube — — FDA listed —
Oxy Total Care Vitamin C Serum 5 mg/mL 10742-1315-01 The 1 vial — — FDA listed —
Up and Up Deep Clean Toner 5 mg/mL 11673-0936-11 TARGET 236.5 ml — — FDA listed —
Salicylic Acid 5 mg/mL 36800-0875-34 Topco 237 ml — — FDA listed —
Even Better Clinical Acne Solutions 5 mg/mL 49527-0114-01 CLINIQUE 1 bottle — — FDA listed —
ACNE solutions liquid MAKEUP SALICYLIC ACID ACNE TREATMENT 5 mg/mL 49527-0751-01 CLINIQUE 1 bottle — — Discontinued —
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 —
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 —
Salicylic Acid 5 mg/mL 55301-0875-34 Your 237 ml — — Discontinued —
Nutricentials Here You Glow Exfoliating Toner 5 mg/mL 62839-1339-01 NSE 150 ml — — FDA listed —
Clear Smart Clear Complexion Toner .5 g/100mL 68828-0289-01 Distribuidora 200 ml — — FDA listed —
In the Clear Acne Serum .5 g/100mL 69366-0414-31 The 1 bottle — — FDA listed —
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M MultiTarget Acne Treatment 5 mg/mLthis 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 —
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 Skin Clearing Blemish Concealer - Deep 20 5 mg/g 69968-0338-01 Kenvue 1 vial — — 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 - Natural Ivory 20 5 mg/mL 69968-0854-01 Kenvue 30 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 - Nude 40 5 mg/mL 69968-0856-01 Kenvue 30 ml — — FDA listed —
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 - Fresh Beige 70 5 mg/mL 69968-0859-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup- Medium Beige 80 5 mg/mL 69968-0860-01 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 - Warm Beige 90 5 mg/mL 69968-0862-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup- Natural Tan 100 5 mg/mL 69968-0863-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Caramel 105 5 mg/mL 69968-0864-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Cocoa 115 5 mg/mL 69968-0865-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Chestnut 135 5 mg/mL 69968-0866-01 Kenvue 30 ml — — FDA listed —
Clearsynergy .25 g/50mL 71617-0100-10 SRL 1 bottle — — FDA listed —
FHF Crisp Start .5 g/100g 72788-0151-03 Summer 1 tube — — 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 —
Ogee Clearganics Targeted Blemish Treatment .5 g/100mL 84261-0154-01 Ogee 10 ml — — FDA listed —
Skinpharmacy Advanced Acne Therapy Pore Refining Facial Mask 5 mg/mL 69842-0077-01 CVS 1 tube — — FDA listed —
Even and Clear Cleanser 5 mg/mL 73453-0003-01 Ambi 177 ml — — FDA listed —
Aveeno CLEAR COMPLEXION foaming cleanser 5 mg/mL 69968-0471-06 Kenvue 177 ml — — FDA listed —
Derma Pella Acne Wash for Oily Skin 5 mg/mL 82160-0764-01 Pella 150 ml — — Discontinued —
Aveeno Positively Radiant Clear Complexion Foaming Cleanser 5 mg/mL 69968-0769-06 Kenvue 177 ml — — FDA listed —
Breakout Clearing Foaming Wash 5 mg/mL 68479-0101-00 Dermalogica 2 ml — — FDA listed —
Deep Cleaning Astringent 5 mg/mL 41250-0775-34 Meijer, 237 ml — — Discontinued —
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
Jun 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.

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 30D478BUNR
    A fatty compound derived from oleic acid (a natural oil component) and glycerol. It acts as an emulsifier and thickener, helping blend oil and water-based ingredients together and giving the medicine its desired texture.
  • UNII 5F4963KLHS
    A synthetic polymer created from acrylamide and sodium acryloyldimethyltaurate that thickens and stabilizes liquid or semi-solid formulations. It helps maintain consistent texture and prevents separation of ingredients in creams, gels, and lotions.
  • UNII F01RIY4371
    A synthetic polymer made from acrylic compounds and taurate, this substance acts as a thickener and stabilizer. It helps give liquid medicines a smooth texture and keeps ingredients from separating.
  • UNII 5F7PJF6AA4
    A fatty acid derivative that combines salicylic acid with a plant-derived oil component. It acts as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the medicine.
  • 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 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 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII FCZ5MH785I
    A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
  • UNII TH7XI54W45
    A synthetic organic compound used as an antioxidant in medications. It helps prevent the active ingredients from breaking down or discoloring when exposed to air or light during storage.
  • UNII 3RJ7186O9W
    A waxy ester derived from plant or mineral sources. It works as an emollient and binder in topical products to help soften skin and hold ingredients together.
  • UNII 918X1OUF1E
    Isohexadecane is a synthetic hydrocarbon oil used as an emollient and solvent in topical medicines. It helps dissolve active ingredients and improves spreadability and absorption through the skin.
  • UNII LYR06W430J
    A synthetic surfactant derived from coconut oil and amino acids. It works as a cleansing agent and emulsifier in topical medicines, helping to mix oil and water-based ingredients and improve skin penetration.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII PHA4727WTP
    Mannose is a simple sugar derived from natural sources. In medicines, it acts as a filler, binder, and sweetener to help form tablets and improve taste.
  • UNII 4042ZC00DY
    A waxy ester derived from myristic acid, used as an emollient and lubricant in topical formulations. It helps soften skin contact, reduce friction during application, and improve the texture and spreadability of creams and ointments.
  • 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 4DGK8B7I3S
    A starch extracted from rice grains. It acts as a filler to add bulk to the tablet or capsule and as a disintegrant to help the medicine break apart and release its active ingredient in your body.
  • 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 A4V5C6R9FB
    Piroctone olamine is a antimicrobial compound used in medicines as a preservative or antifungal agent. It helps prevent bacterial and fungal growth in topical formulations like shampoos and skin products.
  • UNII F75JV2T505
    A synthetic polymer made from ethylene oxide and propylene oxide. It acts as a solubilizer and emulsifier to help mix oil and water-based ingredients, ensuring the medicine disperses evenly throughout the formulation.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 56687D1Z4D
    A natural plant extract from pomegranate fruit, used as a flavor and color ingredient to enhance taste and appearance in medicines.
  • UNII 03KCY6P7UT
    A waxy compound derived from cetyl alcohol and phosphoric acid. It acts as an emulsifier to help blend oil and water ingredients, and as a thickener to give the medicine its proper texture and consistency.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 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 06XEA2VD56
    Sorbitan oleate is an emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in the medicine.
  • UNII YA22H34H9Q
    A chelating agent derived from sodium and organic compounds. It binds to metal ions in the formulation to improve stability and prevent unwanted chemical reactions that could degrade the medicine.
  • UNII 68DV8T89Y2
    A fermentation-derived ingredient from the bacterium Vitreoscilla. It functions as a skin-conditioning agent and humectant in topical formulations, helping to hydrate and soften the skin.
  • 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 TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
  • 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.

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

The official label also stateswater, glycerin, dimethicone, isocetyl stearate, niacinamide, isopropyl lauroyl sarcosinate, silica, ammonium polyacryloyldimethyl taurate, oryza sativa (rice) starch, punica granatum pericarp extract, potassium cetyl phosphate, sorbitan oleate, zinc PCA, glyceryl stearate SE, isohexadecane, sodium hydroxide, myristyl myristate, 2-oleamido-1,3-octadecanediol, mannose, poloxamer 338, propanediol, hydroxyethoxyphenyl butanone, capryloyl salicylic acid, caprylyl glycol, vitreoscilla ferment, citric acid, trisodium ethylenediamine disuccinate, maltodextrin, xanthan gum, pentylene glycol, polysorbate 80, acrylamide/sodium acryloyldimethyltaurate copolymer, piroctone olamine, fragrance

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.

Manufacturer & labeler

LabelerCOSMETIQUE ACTIVE PRODUCTION
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code69625
First marketedJun 2026
Product typeHuman Otc Drug
Portfolio28 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.

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 22 words ▾

Uses for the treatment of acne clears acne blemishes penetrates pores to control acne blemishes helps prevent new acne blemishes from forming

⏱️ 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 5 words ▾

Warnings For external use only

📦 Storage and Handling 10 words ▾

Other information store at room temperature 68°-77°F protect from freezing

🧪 Active Ingredient 5 words ▾

Active ingredient Salicylic acid 0.5%

🧪 Inactive Ingredients 70 words ▾

Inactive ingredients water, glycerin, dimethicone, isocetyl stearate, niacinamide, isopropyl lauroyl sarcosinate, silica, ammonium polyacryloyldimethyl taurate, oryza sativa (rice) starch, punica granatum pericarp extract, potassium cetyl phosphate, sorbitan oleate, zinc PCA, glyceryl stearate SE, isohexadecane, sodium hydroxide, myristyl myristate, 2-oleamido-1,3-octadecanediol, mannose, poloxamer 338, propanediol, hydroxyethoxyphenyl butanone, capryloyl salicylic acid, caprylyl glycol, vitreoscilla ferment, citric acid, trisodium ethylenediamine disuccinate, maltodextrin, xanthan gum, pentylene glycol, polysorbate 80, acrylamide/sodium acryloyldimethyltaurate copolymer, piroctone olamine, fragrance

🎯 Purpose 3 words ▾

Purpose Acne treatment

📄 When Using This Product 36 words ▾

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.

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Questions or Comments 14 words ▾

Questions or comments? 1-888-LRP-LABO 1-888-577-5226 Monday - Friday (9 a.m. - 5 p.m. EST)

📄 Package Label / Principal Display Panel 5 words ▾

3 3ml 40 40 mL

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

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 La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M MultiTarget Acne Treatment (this brand).

Top reported reactions

Vomiting216
Pruritus205
Weight Decreased188
Condition Aggravated184
Urticaria184
Weight Increased183
Hypertension181

Age at onset

Neonate7
Infant1
Child8
Adolescent5
Adult170
Elderly94

Reporter sex

1,852 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization622
Death611
Life-threatening174
Disabling124
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 252 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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 COSMETIQUE ACTIVE PRODUCTION. 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 tube (69625-0058-02). 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?
COSMETIQUE ACTIVE PRODUCTION 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.
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.