Home › NDC Lookup › Ingredients › Salicylic Acid › 56152-5012-01
Purifying Clay Mask Salicylic Acid .5 g/100mL Cream, 88 mL — NDC 56152-5012-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Purifying Clay Mask Salicylic Acid .5 g/100mL Cream, 88 mL — NDC 56152-5012-1 (Billing 56152-5012-01)

by Cosmetic Enterprises Ltd · 88 mL in 1 TUBE

This is a package of 88 mL of Purifying Clay Mask Salicylic Acid .5 g/100mL Cream from Cosmetic Enterprises Ltd, marketed since Jul 2018 and currently FDA-listed. It is this product's only package size.

NDC 56152-5012-01
🏷️ FDA NDC (as labeled) 56152-5012-1 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 56152-5012-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
56152 labeler · 5012 product · 1 package
Package marketed since
Jul 5, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5615250121 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 56152-5012-1
Product NDC 56152-5012
11-digit billing NDC 56152501201
RxCUI 865105
UNII O414PZ4LPZ
Application # M006
SPL Set ID d17e3ff5-f7a4-3e14-e053-2995a90a22b2
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-07-05
Route TOPICAL
Dosage form CREAM
Substance SALICYLIC ACID
Quick answers
  • RxCUI (RxNorm): 865105
Why two NDCs? The FDA registers this code as 56152-5012-1 — a 5-4-1 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 package segment → 56152-5012-01. 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
56152-5012-01 You're viewing this Main listing 88 mL in 1 TUBE 2018-07-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ultra Clear Foaming Cleanser .5 g/100mL 10028-0050-01 ULTRACEUTICALS 150 ml — — FDA listed —
UNBLEMISH Refining Acne Wash .005 g/mL 14222-2111-01 Rodan 1 tube — — FDA listed —
Meijer Foaming Cleanser Acne medication 5 mg/mL 41250-0354-01 Meijer 177 ml — — FDA listed —
Deep Cleaning Astringent 5 mg/mL 41250-0775-34 Meijer, 237 ml — — Discontinued —
Vichy Laboratoires Normaderm Daily Gentle Cleanser 5 mg/mL 49967-0232-01 L'Oreal 125 ml — — FDA listed —
Vichy Laboratoires Normaderm Phytoaction Daily Deep Cleansing 5 mg/mL 49967-0307-01 L'Oreal 200 ml — — FDA listed —
Vichy Laboratoires Normaderm Daily Deep Cleansing Acne Treatment 5 mg/mL 49967-0630-01 L'Oreal 200 ml — — FDA listed —
Salicylic Acid Cleanser 5 mg/mL 54111-0171-02 Bentley 1 tube — — FDA listed —
Purifying Clay Mask .5 g/100mLthis 56152-5012-01 Cosmetic 88 ml — — FDA listed —
ageLOC LumiSpa Treatment Cleanser Acne 5 mg/mL 62839-1495-01 NSE 100 ml — — FDA listed —
Clear Smart Charcoal Blackhead Scrub .5 g/100mL 68828-0001-01 Distribuidora 1 tube — — FDA listed —
Cln Acne Cleanser 5 mg/mL 69530-0857-46 TopMD 100 ml — — FDA listed —
Vichy Laboratoires Normaderm Phytoaction Deep Cleansing 5 mg/mL 69625-0306-01 COSMETIQUE 200 ml — — FDA listed —
Vichy Laboratoires Normaderm Daily Deep Cleansing Acne Treatment 5 mg/mL 69625-0630-01 COSMETIQUE 200 ml — — FDA listed —
Skinpharmacy Advanced Acne Therapy Pore Refining Facial Mask 5 mg/mL 69842-0077-01 CVS 1 tube — — FDA listed —
Aveeno CLEAR COMPLEXION foaming cleanser 5 mg/mL 69968-0471-06 Kenvue 177 ml — — FDA listed —
Neutrogena deep clean purifying cooling gel scrub 5 mg/g 69968-0740-04 Kenvue 119 g — — FDA listed —
Aveeno Positively Radiant Clear Complexion Foaming Cleanser 5 mg/mL 69968-0769-06 Kenvue 177 ml — — FDA listed —
Clarifying Cleanser .5 g/100mL 70381-0128-02 Murad, 1 tube — — FDA listed —
So Totally Clean Deep Pore Cleanser .5 g/100mL 70626-0104-21 ASPIRE 200 ml — — FDA listed —
Clean Getaway Bag 70626-0504-54 ASPIRE 1 kit — — FDA listed —
MDacne Customized Acne Cleanser Hydrating Salicylic Acid 5 mg/mL 71804-0534-00 MDAlgorithms 59 ml — — FDA listed —
Salicylic Acid Cleanser 5 mg/g 73318-7001-02 Skin 1 bottle — — FDA listed —
Even and Clear Cleanser 5 mg/mL 73453-0003-01 Ambi 177 ml — — FDA listed —
Peach and Lily Peaches Slices Acne Oil Acne Free Moisturizer 5 mg/mL 81515-0502-01 Peach 80 ml — — FDA listed —
Caring Mill Acne Clearing Cleanser .5 g/100mL 81522-0100-01 FSA 250 ml — — FDA listed —
Derma Pella Acne Wash for Oily Skin 5 mg/mL 82160-0764-01 Pella 150 ml — — Discontinued —
Creamy Foam Cleanser .5 g/100mL 82870-0002-01 Dime 120 ml — — FDA listed —
Freshiny Facial Cleanser Acne Treatment 5 mg/g 84544-0001-01 Guangdong 1 tube — — FDA listed —
Perricone MD Acne Relief Retinol Treatment and Moisturizer .5 g/100mL 84448-0537-21 THG 1 tube — — FDA listed —
Proactiv Blackhead Dissolving .5 g/100mL 11410-0024-05 Alchemee, 1 tube — — FDA listed —
Perricone MD Acne Relief Calming Treatment and Hydrator Salicylic Acid Acne Treatment .5 g/100mL 84448-0540-21 THG 1 tube — — FDA listed —
Gentle Acne Serum .5 g/100mL 83286-0016-01 Drmtlgy, 59 ml — — FDA listed —
Proactiv Plus Complexion Perfecting Hydrator .5 g/100mL 11410-0023-00 Alchemee, 1 tube — — FDA listed —
Scrub So Clean Acne-Fighting Super Scrub .5 g/100mL 70626-0107-11 ASPIRE 100 ml — — FDA listed —
Clear Smart Clear Pore Hydrator .5 g/100mL 68828-0701-01 Distribuidora 50 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2018
On the market since
Jul 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.

🧪 Avoiding an ingredient? See Salicylic Acid Topical inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • UNII 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII B423VGH5S9
    A natural fruit ingredient derived from apples, used as a flavoring agent and sweetener to improve taste and palatability of the medicine.
  • UNII A3N5ZCN45C
    Bentonite is a naturally occurring clay mineral used in medicines as a binder and absorbent. It helps hold tablet ingredients together and can absorb moisture or unwanted substances in the formulation.
  • UNII 9P2U39H18W
    Bilberry is a natural plant extract from bilberry fruit. It's used in medicines as a colorant and flavoring agent to improve taste and appearance.
  • UNII N4G8379626
    A plant-based oil extracted from rapeseed (also called canola). It's used in medicines as an emulsifier and lubricant to help blend ingredients together and improve how the product flows and feels.
  • 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 D072FFP9GU
    Cetyl esters wax is a waxy substance made from natural or synthetic fatty acids. It's used as a binder, hardening agent, and coating material to give tablets and capsules their structure and texture.
  • UNII RYQ4R60M02
    A green algae ingredient used as a natural colorant and nutritional filler in supplements and medications. It adds color and bulk to tablets and capsules.
  • 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 497G7G1SL1
    Copper pidolate is a copper compound combined with pidolic acid, a naturally occurring amino acid derivative. It's used as a mineral supplement ingredient to provide copper content in formulations.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII 24H4NWX5CO
    Kaolin is a naturally occurring clay mineral. It's used in tablets and capsules as a filler and absorbent to add bulk, improve texture, and help bind ingredients together.
  • UNII 113171Q70B
    Lauroyl lysine is a compound made by combining an amino acid (lysine) with a fatty acid (lauric acid). It works as a glidant and lubricant to help powder particles flow smoothly during manufacturing and tablet compression.
  • UNII D7BC5B0F46
    Illite is a naturally occurring clay mineral. It serves as a filler and absorbent in medicines to add bulk, improve texture, and help the tablet or powder hold together properly.
  • UNII 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • UNII 6M3P64V0NC
    A fine powder made from magnesium, aluminum, and silicon compounds. It absorbs moisture and helps keep medicine ingredients from clumping or separating, so the product stays stable and flows smoothly during manufacturing.
  • 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 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 632GS99618
    Sodium lauroyl sarcosinate is a mild, plant-derived cleaning agent used in medicines as a surfactant and emulsifier. It helps mix oil and water-based ingredients and may aid tablet disintegration.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 24SC3U704I
    A powdery carbohydrate extracted from tapioca plant roots. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your digestive system.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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.

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

The official label also statesInactive ingredients Water (Aqua), Kaolin, Bentonite, Titanium Dioxide, Butylene Glycol, C12-15 Alkyl Benzoate, Cetyl Esters, Magnesium Aluminum Silicate, Glycerin, Illite, Tapioca Starch, Zea Mays (Corn) Starch, Camellia Sinensis (Green Tea) Leaf Extract, Pyrus Malus (Apple) Fruit Extract, Chrysanthemum Indicum (Golden Chamomile) Extract, Hydrolyzed Rhodophycea (Red Algae) Extract, Chlorella Vulgaris (Algae) Extract, Epilobium Fleischeri (Willowherb) Extract, Vaccinium Myrtillus (Bilberry) Fruit Extract, Brassica Camprestris (Rapeseed) Seed Oil, Allantoin, Bisabolol, Zinc PCA, Copper PCA, Lauroyl Lysine, Sodium Lauroyl Sarcosinate, Xanthan Gum, Citric Acid, Sodium Citrate, Sodium Chloride, Phenoxyethanol, Ethylhexylglycerin

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

LabelerCosmetic Enterprises Ltd
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code56152
First marketedJul 2018
Product typeHuman Otc Drug
Portfolio20 products on file

More NDCs from Cosmetic Enterprises Ltd labeler code 56152

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 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

Stop use and ask a doctor if skin irritation occurs or gets worse.

⏱️ Dosage and Administration 26 words ▾

Directions Use on clean skin. Apply a generous layer all over face and neck. Leave on for 5-10 minutes. Rinse thoroughly. Use as often as needed.

⚠️ Warnings 53 words ▾

Warnings For external use only Do not use on broken skin on large areas of the body 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

🧪 Active Ingredient 8 words ▾

Active Ingredients Purpose Salicylic Acid 0.5% Acne Treatment

🧪 Inactive Ingredients 86 words ▾

Inactive ingredients Water (Aqua), Kaolin, Bentonite, Titanium Dioxide, Butylene Glycol, C12-15 Alkyl Benzoate, Cetyl Esters, Magnesium Aluminum Silicate, Glycerin, Illite, Tapioca Starch, Zea Mays (Corn) Starch, Camellia Sinensis (Green Tea) Leaf Extract, Pyrus Malus (Apple) Fruit Extract, Chrysanthemum Indicum (Golden Chamomile) Extract, Hydrolyzed Rhodophycea (Red Algae) Extract, Chlorella Vulgaris (Algae) Extract, Epilobium Fleischeri (Willowherb) Extract, Vaccinium Myrtillus (Bilberry) Fruit Extract, Brassica Camprestris (Rapeseed) Seed Oil, Allantoin, Bisabolol, Zinc PCA, Copper PCA, Lauroyl Lysine, Sodium Lauroyl Sarcosinate, Xanthan Gum, Citric Acid, Sodium Citrate, Sodium Chloride, Phenoxyethanol, Ethylhexylglycerin

🎯 Purpose 24 words ▾

Uses For the treatment of acne penetrates pores to eliminate most acne blemishes, blackheads, and whiteheads Helps prevent new acne blemishes, blackheads and whiteheads

📄 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.

📄 Package Label / Principal Display Panel 22 words ▾

Clear Paula's Choice Purifying Clay Mask Willowherb & Green Tea Blemish Prone Skin 88 ml / 3 fl. oz. Purifying Clay Mask

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 Purifying Clay Mask (this brand).

Top reported reactions

Vomiting216
Pruritus205
Weight Decreased188
Condition Aggravated184
Urticaria184
Weight Increased183
Hypertension181

Reporter sex

0 reports

Serious outcomes

Death611
Life-threatening174
Disabling124
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 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 ✓ 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.
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 Cosmetic Enterprises Ltd. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cosmetic Enterprises Ltd is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 56152-5003-01 · Cosmetic 56153-0001-05 · Ming →
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.