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ACNE AND LINE CORRECTING SERUM SALICYLIC ACID 10 mg/mL Lotion — NDC 49527-053-01 (Billing 49527-0053-01)

by CLINIQUE LABORATORIES LLC · 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE

This is a package of ACNE AND LINE CORRECTING SERUM SALICYLIC ACID 10 mg/mL Lotion from CLINIQUE LABORATORIES LLC, marketed since Aug 2016 and currently FDA-listed. It is this product's only package size.

NDC 49527-0053-01
🏷️ FDA NDC (as labeled) 49527-053-01 billing pads the product segment with a zero
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49527-053-01
Product NDC 49527-053
11-digit billing NDC 49527005301
RxCUI 245199
UNII O414PZ4LPZ
UPC 0020714759810
Application # M006
SPL Set ID b03bdef4-a099-4543-8673-85466bd64961
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-08-15
Route TOPICAL
Dosage form LOTION
Substance SALICYLIC ACID
Quick answers
  • RxCUI (RxNorm): 245199
Why two NDCs? The FDA registers this code as 49527-053-01 — 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 → 49527-0053-01. 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
49527-0053-01 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE 2016-08-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acne And Line Correcting Serum 10 mg/mLthis 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 —
Anti-Everything Face Moisturizer 1 g/100mL 54111-0181-01 Bentley 1 bottle — — FDA listed —
Clear Improvement Pore Clearing Moisturizer 10 mg/mL 59427-0015-01 ORIGINS 1 jar — — FDA listed —
Pharma Clear Moisturizer 1 g/100mL 67879-0103-11 PHARMAGEL 175 ml — — FDA listed —
Acne Advanced Clarifying Hydrator 10 mg/mL 15751-3030-02 Eminence 1 bottle — — 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 —
The Inkey List Succinic Acid Acne Treatment 10 mg/mL 81136-0017-01 Brand 15 ml — — Discontinued —
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 —
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

🏛️
2016
On the market since
Aug 2016
📍
2026
Currently FDA-listed
10 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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII L4EL31FWIL
    A synthetic peptide (short chain of amino acids) used as a conditioning or texture-enhancing agent in topical formulations. It helps improve product feel and skin compatibility in creams and lotions.
  • UNII 290O2PQ83R
    A stabilized form of vitamin C used in topical products as an antioxidant ingredient. It helps prevent degradation of other active ingredients and maintains product stability during storage.
  • UNII W59H9296ZG
    A synthetic polymer made from acrylic compounds and vinylpyrrolidone. It works as a film-former and thickener in topical products, helping create a smooth texture and improve how the medication spreads on skin.
  • UNII OEB4R3WW9C
    A silicone-based emulsifier and anti-foaming agent derived from polyethylene glycol. It helps prevent foam formation during manufacturing and aids in blending oil and water components in liquid formulations.
  • 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 3G6A5W338E
    Caffeine is a natural stimulant compound commonly extracted from coffee beans and tea leaves. In medicines, it serves as an active booster in pain relievers and cold products to enhance alertness and improve the effectiveness of other ingredients.
  • 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 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII 97C5T2UQ7J
    Cholesterol is a fatty substance found naturally in animal tissues. In medications, it's used as an ingredient in liposomal formulations and lipid-based drug delivery systems to help encapsulate and stabilize active drugs for better absorption.
  • 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 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 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 YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII 25G622K2RA
    A silicone-based surfactant that helps blend oil and water in cosmetic or topical formulations. It reduces surface tension to improve product spreadability and texture.
  • UNII J3QD0LD11P
    A synthetic compound made by combining glucose with methyl alcohol and polyethylene glycol. It acts as an emulsifier and solvent to help blend water and oil-based ingredients and improve how the medicine dissolves or spreads.
  • UNII S73ZQI0GXM
    Methyl trimethicone is a silicone-based lubricant and glidant used in tablets and capsules. It reduces friction between particles and equipment during manufacturing, helping the medicine flow smoothly and compress evenly.
  • 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 Y1YXJ1M6Z5
    A plant extract from evening primrose flowers used as a natural emollient and skin-conditioning agent in topical formulations to help soften and smooth the product texture.
  • UNII HO4ZT5S86C
    A synthetic peptide derived from amino acids, used as a skin-conditioning agent and emollient in topical formulations to help soften and smooth the skin surface.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 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 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 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 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 R44IWB3RN5
    Soy protein is a plant-based protein derived from soybeans. It's used in medicines as a binder to hold tablet ingredients together and sometimes as a filler to add bulk and texture to the formulation.
  • UNII L7HT8F1ZOD
    A plant-based oil extracted from soybeans. It's used as an emulsifier and lubricant to help mix ingredients evenly and prevent sticking during tablet or capsule manufacturing.
  • 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 8617Z5FMF6
    Whey is a milk-derived protein and carbohydrate byproduct. It functions as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the formulation.
  • 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.

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

The official label also stateswater\aqua\eau • dimethicone • butylene glycol • vinyl dimethicone/methicone silsesquioxane crosspolymer • methyl trimethicone • polysorbate 20 • bis-peg-18 methyl ether dimethyl silane • lauryl peg-9 polydimethylsiloxyethyl dimethicone • glycerin • methyl gluceth-20 • polysilicone-11 • oenothera biennis (evening primrose) flower extract • glycine soja (soybean) seed extract • sigesbeckia orientalis (st. paul's wort) extract • salvia sclarea (clary) extract • plankton extract • laminaria saccharina extract • acetyl hexapeptide-8 • acetyl glucosamine • caffeine • gylcine soja (soybean) protein • aminopropyl ascorbyl phosphate • cholesterol • caprylyl glycol • micrococcus lysate • palmitoyl hexapeptide-12 • lecithin • whey protein\lactis protein\protéine du petit-lait • sodium hyaluronate • tocopheryl acetate • peg-8 • sodium hydroxide • ammonium acryloyldimethyltaurate/vp copolymer • xanthan gum • carbomer • glyceryl polymethacrylate • sodium benzoate • sodium citrate • disodium edta • phenoxyethanol [iln42038]

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 2016
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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

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

⏱️ Dosage and Administration 10 words ▾

Directions Apply 2-3 drops twice a day all over face.

⚠️ 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, get medical help 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 1.0%

🧪 Inactive Ingredients 140 words ▾

Inactive ingredients water\aqua\eau • dimethicone • butylene glycol • vinyl dimethicone/methicone silsesquioxane crosspolymer • methyl trimethicone • polysorbate 20 • bis-peg-18 methyl ether dimethyl silane • lauryl peg-9 polydimethylsiloxyethyl dimethicone • glycerin • methyl gluceth-20 • polysilicone-11 • oenothera biennis (evening primrose) flower extract • glycine soja (soybean) seed extract • sigesbeckia orientalis (st. paul's wort) extract • salvia sclarea (clary) extract • plankton extract • laminaria saccharina extract • acetyl hexapeptide-8 • acetyl glucosamine • caffeine • gylcine soja (soybean) protein • aminopropyl ascorbyl phosphate • cholesterol • caprylyl glycol • micrococcus lysate • palmitoyl hexapeptide-12 • lecithin • whey protein\lactis protein\protéine du petit-lait • sodium hyaluronate • tocopheryl acetate • peg-8 • sodium hydroxide • ammonium acryloyldimethyltaurate/vp copolymer • xanthan gum • carbomer • glyceryl polymethacrylate • sodium benzoate • sodium citrate • disodium edta • phenoxyethanol [iln42038]

🎯 Purpose 3 words ▾

Purpose Acne Treatment

📄 When Using This Product 42 words ▾

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 21 words ▾

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

📄 Package Label / Principal Display Panel 37 words ▾

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton acne C CLINIQUE acne solutions acne + line correcting serum SALICYLIC ACID ACNE MEDICATION ALL SKIN TYPES 1 FL.OZ.LIQ./30 ml e PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

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 ACNE AND LINE CORRECTING SERUM (this brand).

Top reported reactions

Vomiting216
Pruritus205
Weight Decreased188
Condition Aggravated184
Urticaria184
Weight Increased183
Hypertension181

Reporter sex

1,852 reports

Serious outcomes

Death611
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 243 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 CLINIQUE LABORATORIES LLC. Listing status can change — the directory data on this page refreshes weekly.
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.
← 49527-0051-01 · CLINIQUE 49527-0056-01 · 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.