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ACNE SOLUTIONS CLINICAL CLEARING gel SALICYLIC ACID 10 mg/mL Gel — NDC 49527-0116-03 package photo

ACNE SOLUTIONS CLINICAL CLEARING gel SALICYLIC ACID 10 mg/mL Gel

by CLINIQUE LABORATORIES LLC · 1 TUBE in 1 CARTON (49527-116-03) / 3 mL in 1 TUBE
NDC 49527-0116-03
🏷️ FDA NDC (as labeled) 49527-116-03 billing pads the product segment with a zero
This package
Contains3 mL in 1 tube Pack sizes3 compare ↓
Also comes in: 30 mL 49527-0116-01 15 mL 49527-0116-02
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 2027. 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) 49527-116-03
Product NDC 49527-116
11-digit billing NDC 49527011603
RxCUI 251380
UNII O414PZ4LPZ
UPC 0020714653651
Application # M006
SPL Set ID 0d0c763b-d9aa-c342-e063-6294a90a6e79
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2027)
Marketing start 2023-12-21
Route TOPICAL
Dosage form GEL
Substance SALICYLIC ACID
Why two NDCs? The FDA registers this code as 49527-116-03 — 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 → 49527-0116-03. 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

LabelerCLINIQUE LABORATORIES LLC
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code49527
First marketedDec 2023
Product typeHuman Otc Drug
Portfolio61 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 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 F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • 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 59TL3WG5CO
    A synthetic polymer made by crosslinking acrylic acid with allyl sucrose. It thickens liquids, forms gels, and helps control how fast the medicine is released in your body.
  • UNII UDY3H1OUX5
    A natural extract from sea whips, a type of soft coral. It may be used in formulations for its potential binding or texture-modifying properties in topical or oral products.
  • UNII 68CMP2MB55
    A brown seaweed extract used as a thickener and stabilizer in liquid medicines and suspensions. It helps maintain consistent texture and prevents ingredients from separating.
  • 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 101I4J0U34
    Witch hazel is a plant extract obtained from the leaves and bark of the North American shrub Hamamelis virginiana. It functions as an astringent and skin-conditioning agent in topical products, helping to tone and prepare the skin.

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

The official label also statesalcohol denat.,hamamelis virginiana (witch hazel) water,alcohol,acrylates/c10-30 alkyl acrylate crosspolymer,water\aqua\eau,laminaria saccharina extract,butylene glycol,benzalkonium chloride <iln52627>

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 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: 30 mL 15 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
ACNE SOLUTIONS CLINICAL CLEARING gel 10 mg/mLthis 49527-0116-03 CLINIQUE 1 tube — — Discontinued —
Cover FX Mattifying Primer Plus Acne Treatment 1 g/100mL 68327-0073-01 Cover 1 tube — — FDA listed —
Clear Smart Blemish Spot Treatment 1 g/100mL 68828-0245-01 Distribuidora 15 ml — — FDA listed —
Acne Fighting Spot with Aloe clear 10 mg/mL 70412-0411-06 Zhejiang 1 bottle — — FDA listed —
Acne Fighting Spot Gel 10 mg/mL 76354-0414-01 e.l.f. 1 tube — — FDA listed —
ELF ACNE Fighting Spot Gel with Aloe Clear 1 g/100mL 76354-0616-01 e.l.f. 6 ml — — FDA listed —
Acne Advanced Clarifying Hydrator 10 mg/mL 15751-3030-02 Eminence 1 bottle — — FDA listed —
Acne And Line Correcting Serum 10 mg/mL 49527-0053-01 CLINIQUE 1 bottle — — FDA listed —
Vichy Laboratoires Normaderm BHA Exfoliating Serum Acne Treatment 10 mg/mL 49967-0230-01 L'Oreal 1 bottle — — FDA listed —
Serious Skincare Continuously Clear Acne Medication For Problematic skin Dry Lo Pro All- Over Treatment 10 mg/mL 53755-0110-00 Flageoli 1 bottle — — FDA listed —
Clear Improvement Pore Clearing Moisturizer 10 mg/mL 59427-0015-01 ORIGINS 1 jar — — FDA listed —
Vichy Laboratoires Normaderm BHA Exfoliating Acne Treatment 10 mg/mL 69625-0231-01 COSMETIQUE 1 bottle — — FDA listed —
The Inkey List Succinic Acid Acne Treatment 10 mg/mL 81136-0017-01 Brand 15 ml — — FDA listed —
blackhead solutions self-heating blackhead extractor acne medication 10 mg/mL 49527-0061-01 CLINIQUE 1 tube — — Discontinued —
Acne Solutions Spot Healing Acne Medication 10 mg/mL 49527-0825-01 CLINIQUE 1 tube — — Discontinued —
Acne Calming Water Cream 10 mg/mL 76354-0416-01 e.l.f. 1 bottle — — FDA listed —
blackhead solutions 7 day deep pore cleanse and scrub acne medication 10 mg/mL 49527-0062-02 CLINIQUE 1 tube — — Discontinued —
Neutrogena Stubborn Texture Daily Cleanser 10 mg/mL 69968-0704-06 Kenvue 186 ml — — FDA listed —
NAELI Exfoliator AHA BHA Face Cleanser 10 mg/mL 73670-0620-00 ALLI 1 bottle — — FDA listed —
NAELI Exfoliator AHA-BHA Face Cleanser 10 mg/mL 73670-0606-00 ALLI 1 bottle — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2023
On the market since
Dec 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
49527-0116-01 1 BOTTLE in 1 CARTON (49527-116-01) / 30 mL in 1 BOTTLE 2023-12-21 Inactivated by FDA
49527-0116-02 1 BOTTLE in 1 CARTON (49527-116-02) / 15 mL in 1 BOTTLE 2023-12-21 Inactivated by FDA
49527-0116-03 You're viewing this 1 TUBE in 1 CARTON (49527-116-03) / 3 mL in 1 TUBE 2023-12-21 Inactivated by FDA

Pack size FAQ

What quantity is in NDC 49527-0116-03?
NDC 49527-0116-03 is listed by the FDA — 1 tube in 1 carton / 3 ml in 1 tube.
What NDC number is used to bill for this package of ACNE SOLUTIONS CLINICAL CLEARING gel SALICYLIC ACID 10 mg/mL Gel?
Bill NDC 49527-0116-03 — the 11-digit billing format is 49527011603. 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 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 49527-116-03, 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: 49527-0116-03, written without dashes as 49527011603. 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 49527-0116-03, the first segment (49527) is the labeler code FDA assigned to CLINIQUE LABORATORIES LLC; the middle segment (0116) 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 bottle (49527-0116-01), 1 bottle (49527-0116-02). 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?
CLINIQUE LABORATORIES LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 13 words ▾

Uses treats acne clears acne blemishes helps prevent development of new acne blemishes

⏱️ Dosage and Administration 37 words ▾

Directions apply a thin layer to entire face twice a day after cleansing avoid eye area spot-apply if you are using another leave-on acne treatment if bothersome dryness or peeling occurs, reduce usage to every other day

⚠️ Warnings 68 words ▾

Warnings For external use only When using this product using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. Keep out of reach of children. If product is swallowed, call a doctor or contact a Poison Control Center right away.

📦 Storage and Handling 14 words ▾

Other information protect the product in this container from excessive heat and direct sun

🧪 Active Ingredient 5 words ▾

Active ingredient Salicylic Acid 1%

🧪 Inactive Ingredients 16 words ▾

Inactive ingredients alcohol denat.,hamamelis virginiana (witch hazel) water,alcohol,acrylates/c10-30 alkyl acrylate crosspolymer,water\aqua\eau,laminaria saccharina extract,butylene glycol,benzalkonium chloride <iln52627>

🎯 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 ↗
← 49527-0114-01 · CLINIQUE 49527-0117-01 · CLINIQUE →
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.