Home › NDC Lookup › Ingredients › Salicylic Acid › 49527-0061-01
blackhead solutions self-heating blackhead extractor acne medication Salicylic acid 10 mg/mL Cream — NDC 49527-0061-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

blackhead solutions self-heating blackhead extractor acne medication Salicylic acid 10 mg/mL Cream — NDC 49527-061-01 (Billing 49527-0061-01)

by CLINIQUE LABORATORIES LLC · 1 TUBE, WITH APPLICATOR in 1 CARTON / 20 mL in 1 TUBE, WITH APPLICATOR

This is a package of blackhead solutions self-heating blackhead extractor acne medication Salicylic acid 10 mg/mL Cream from CLINIQUE LABORATORIES LLC, no longer marketed (first marketed Aug 2018), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 49527-0061-01
🏷️ FDA NDC (as labeled) 49527-061-01 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ 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 →

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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49527-061-01
Product NDC 49527-061
11-digit billing NDC 49527006101
RxCUI 417424
UNII O414PZ4LPZ
UPC 0020714817909
Application # M006
SPL Set ID e36ba6f7-5d75-4a12-af03-2a4b60a712e4
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2018-08-30
Route TOPICAL
Dosage form CREAM
Substance SALICYLIC ACID
Quick answers
  • RxCUI (RxNorm): 417424
Why two NDCs? The FDA registers this code as 49527-061-01 — 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 → 49527-0061-01. 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 →

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.

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.
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
49527-0061-01 You're viewing this Main listing 1 TUBE, WITH APPLICATOR in 1 CARTON / 20 mL in 1 TUBE, WITH APPLICATOR 2018-08-30 — Inactivated by FDA

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acne Advanced Clarifying Hydrator 10 mg/mL 15751-3030-02 Eminence 1 bottle — — FDA listed —
blackhead solutions self-heating blackhead extractor acne medication 10 mg/mLthis 49527-0061-01 CLINIQUE 1 tube — — Discontinued —
clear days ahead oil-free salicylic acid acne treatment and moisturizer .6 g/60mL 50184-1010-01 Philosophy 60 ml — — FDA listed —
Organic Fruits Acne Spot Treatment - Yuja (1% Salicylic Acid) .3 g/30g 73391-0103-02 ENS 1 tube — — FDA listed —
Acne Calming Water Cream 10 mg/mL 76354-0416-01 e.l.f. 1 bottle — — FDA listed —
The Inkey List Succinic Acid Acne Treatment 10 mg/mL 81136-0017-01 Brand 15 ml — — Discontinued —
Blemish Spot Treatment .01 g/g 83657-0472-01 Skin 15 g — — FDA listed —
AOSORW Folliculitis and Acne Treatment Cream 1 g/100g 85498-0012-01 SpineStatus 100 g — — FDA listed —
Milia remover .01 g/mL 87278-0005-01 Guangxi 15 ml — — 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 —
Acne Fighting Spot with Aloe clear 10 mg/mL 70412-0411-06 Zhejiang 1 bottle — — FDA listed —
Acne Solutions Spot Healing Acne Medication 10 mg/mL 49527-0825-01 CLINIQUE 1 tube — — Discontinued —
Acne Fighting Spot Gel 10 mg/mL 76354-0414-01 e.l.f. 1 tube — — FDA listed —
blackhead solutions 7 day deep pore cleanse and scrub acne medication 10 mg/mL 49527-0062-02 CLINIQUE 1 tube — — Discontinued —
ACNE SOLUTIONS CLINICAL CLEARING gel 10 mg/mL 49527-0116-01 CLINIQUE 1 bottle — — 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

🏛️
2018
On the market since
Aug 2018
📍
2026
Currently FDA-listed
8 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.

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 NRA4497HC5
    A natural plant extract from bamboo stems used as a filler and texturizing agent in medicines. It helps give the product bulk and a smooth, consistent texture.
  • 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 2RF6EJ0M85
    Diatomaceous earth is a fine powder made from fossilized remains of diatoms, tiny aquatic organisms. It acts as a glidant and anti-caking agent, helping medicine flow smoothly during manufacturing and preventing clumping in the final product.
  • 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 9E4CO0W6C5
    A silicone-based polymer that forms soft, spongy particles. Used as a texture modifier and suspending agent to improve how the product feels and flows, and to help keep ingredients evenly distributed throughout the formulation.
  • UNII UG00KM4WR7
    A plastic polymer used as a container material and film coating. It helps protect the medicine from moisture and air exposure during storage and shipping.
  • UNII H1109Z9J4N
    A natural emulsifier derived from soybean oil. It helps mix oil and water-based ingredients together, ensuring even distribution of active ingredients throughout the medicine.
  • UNII A8289P68Y2
    Isododecane is a lightweight liquid hydrocarbon used as a solvent and spreadability agent in topical formulations. It helps dissolve active ingredients and makes the product easier to apply and absorb into the skin.
  • UNII S4V5BS6GCX
    A synthetic oily liquid used as an emollient and solvent in topical medications. It helps dissolve active ingredients and creates a smooth, spreadable texture on the skin.
  • UNII DE08037SAB
    Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
  • UNII V956696549
    N-Acetylglucosamine is a naturally occurring sugar compound derived from chitin. In medicines, it typically serves as a filler or binding agent to help hold tablet ingredients together and add bulk to the formulation.
  • UNII DR0K5NOJ4R
    Phenyl trimethicone is a silicone-based lubricant and glidant. It helps powder particles flow smoothly and reduces friction during tablet or capsule manufacturing and filling.
  • 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 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 NT5NN5KL16
    Pumice is a porous volcanic rock. It's used in medicines as a mild abrasive or polishing agent, and sometimes as a filler to add bulk to solid dosage forms.
  • 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 3YYE6VJS0P
    A compound derived from licorice root extract combined with stearyl alcohol. It acts as an emollient and skin-conditioning agent that helps soften and smooth the product's texture while providing a protective barrier on the skin or mucous membranes.
  • UNII 7K3W1BIU6K
    A synthetic oil derived from glycerin and hexanoic acid. It acts as an emollient and lubricant in topical formulations to soften skin and improve product spreadability.
  • 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.

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

The official label also statesmagnesium sulfate • dimethicone • isononyl isononanoate • isododecane • polysilicone-11 • phenyl trimethicone • hydrogenated lecithin • acetyl glucosamine • polysorbate 20 • polysorbate 80 • polyethylene • diatomaceous earth\solum diatomeae\terre de diatomées • triethylhexanoin • pumice • bambusa arundinacea (bamboo) stem extract • peg-15/lauryl dimethicone crosspolymer • caprylyl glycol • stearyl glycyrrhetinate • water\aqua\eau • silica [iln43644]

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

LabelerCLINIQUE LABORATORIES LLC
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code49527
First marketedAug 2018
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.

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 19 words ▾

Uses reduces the number of blackheads helps keep skin clear of new blackheads helps prevent development of new blackheads

⏱️ Dosage and Administration 38 words ▾

Directions Use 3 times a week on clean, dry skin. Unscrew top to dispense product. Apply thin layer on blackhead-prone areas. Reattach top. Wet product on skin to activate heat. Massage 15-30 seconds with applicator tip, then rinse.

⚠️ 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 one topical acne medication should be used unless directed by a doctor. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Keep out of eyes.

🧪 Active Ingredient 5 words ▾

Active ingredient Salicylic Acid 1.0%

🧪 Inactive Ingredients 61 words ▾

Inactive ingredients magnesium sulfate • dimethicone • isononyl isononanoate • isododecane • polysilicone-11 • phenyl trimethicone • hydrogenated lecithin • acetyl glucosamine • polysorbate 20 • polysorbate 80 • polyethylene • diatomaceous earth\solum diatomeae\terre de diatomées • triethylhexanoin • pumice • bambusa arundinacea (bamboo) stem extract • peg-15/lauryl dimethicone crosspolymer • caprylyl glycol • stearyl glycyrrhetinate • water\aqua\eau • silica [iln43644]

🎯 Purpose 3 words ▾

Purpose Acne Treatment

📄 When Using This Product 40 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 one topical acne medication should be used unless directed by a doctor.

📄 Keep Out of Reach of Children 25 words ▾

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

📄 Package Label / Principal Display Panel 29 words ▾

PRINCIPAL DISPLAY PANEL - 20 ml Tube Carton blackheads CLINIQUE blackhead solutions self-heating blackhead extractor SALICYLIC ACID ACNE MEDICATION ALL SKIN TYPES .68 FL.OZ.LIQ./20 ml e Principal Display Panel

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 Salicylic acid — the ingredient across all brands.

Top reported reactions

Dry Skin12,766
Erythema12,318
Acne11,763
Skin Burning Sensation11,557
Skin Irritation7,730
Skin Exfoliation5,759
Rash4,766

Age at onset

Neonate7
Infant1
Child16
Adolescent30
Adult334
Elderly131

Reporter sex

52,594 reports
Male · 27%
Female · 73%
Unknown · 0%

Serious outcomes

Hospitalization799
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 18,985 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 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.
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.
← 49527-0060-01 · CLINIQUE 49527-0062-02 · 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.