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Parma Anus Skin Premium Cleanser ALLANTOIN 3 mg/mL Gel — NDC 71614-0002-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Parma Anus Skin Premium Cleanser ALLANTOIN 3 mg/mL Gel — NDC 71614-002-02 (Billing 71614-0002-02)

by PARMA KOREA · 1 BOTTLE in 1 CARTON / 100 mL in 1 BOTTLE

This is a package of Parma Anus Skin Premium Cleanser ALLANTOIN 3 mg/mL Gel from PARMA KOREA, marketed since Aug 2018 and currently FDA-listed. It is this product's only package size.

NDC 71614-0002-02
🏷️ FDA NDC (as labeled) 71614-002-02 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

NDC database record

One package, one record: these facts belong to NDC 71614-002-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
71614 labeler · 002 product · 02 package
Package marketed since
Aug 27, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7161400202 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71614-002-02
Product NDC 71614-002
11-digit billing NDC 71614000202
UNII 344S277G0Z
SPL Set ID 9694aea6-db34-409e-b4fb-4d4fe6fd33fa
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-08-27
Route TOPICAL
Dosage form GEL
Substance ALLANTOIN
Why two NDCs? The FDA registers this code as 71614-002-02 — 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 → 71614-0002-02. 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.

Clinical

🧪 What is this product?

This is a topical gel cleanser containing 3 mg/mL of allantoin, an ingredient commonly used in skin care products. Allantoin is typically included in cleansers and personal hygiene products for its role in skin conditioning. This product is marketed as an unapproved drug and has not received FDA approval.

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
71614-0002-02 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 100 mL in 1 BOTTLE 2018-08-27 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Parma Anus Skin Premium Cleanser 3 mg/mLthis 71614-0002-02 PARMA 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 TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 32MP823R8S
    A plant-derived ingredient from mugwort root, used in traditional herbal formulations. It may function as a flavoring agent, botanical extract, or natural additive in the medicine.
  • UNII CUQ3A77YXI
    Panax ginseng root is a plant extract traditionally used in herbal preparations. In medications, it may serve as an active botanical ingredient or be included for flavoring and as a natural preservative or binder in formulations.
  • UNII FIW80T6P6V
    A plant extract from bamboo that acts as a natural filler and texture agent in medications. It helps give the product structure and consistency while being derived from plant material.
  • 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 7M867G6T1U
    Centella asiatica is a plant extract used in medicines as a skin-conditioning or soothing ingredient. It helps maintain product stability and may support skin comfort in topical formulations.
  • UNII 21X4Y0VTB1
    A surfactant derived from coconut oil that helps mix oil and water components. It's used in formulations as an emulsifier and foam booster to improve product texture and stability.
  • UNII 3YC120743U
    Diglycerin is a humectant and solvent derived from glycerin. It helps retain moisture in the formulation and improves texture and stability in liquid or semi-solid medicines.
  • 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 S546YLW6E6
    Eucalyptus globulus leaf is a plant-derived ingredient that may serve as a flavoring agent or aromatic component in medications. It is commonly used to add taste or scent to oral formulations.
  • UNII UDA30A2JJY
    A plant extract from witch hazel used as an astringent and skin-conditioning agent in topical formulations. It helps tone and soothe the skin while functioning as a natural preservative.
  • UNII R33S7TK2EP
    Hydroxyethyl cellulose is a thickening agent made from processed plant cellulose. It's used in medicines to increase viscosity, improve texture, and help distribute active ingredients evenly throughout liquid or semi-solid formulations.
  • UNII 76LN7P7UCU
    Lauryl glucoside is a mild plant-based cleansing agent made from coconut oil and glucose. It's used in medicines as a surfactant to help dissolve and distribute ingredients evenly throughout the formulation.
  • UNII NH496X0UJX
    Mandelic acid is an organic acid derived from almonds. It functions as a buffer and pH adjuster in medications, helping maintain the product's stability and proper acidity level.
  • UNII 3VNC7T6Z02
    A plant extract from chamomile flowers used as a flavoring and fragrance agent in medicines. It adds taste and aroma to improve how the medicine smells and tastes.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 1LIB31N73G
    Mung bean is a legume-derived plant ingredient used as a binder and filler in medications. It helps hold the tablet or capsule together and adds bulk to the formulation.
  • UNII TZK30RF92W
    A lab-made protein fragment containing a few linked amino acids. It's used in formulations as a skin-conditioning agent or penetration enhancer to help other ingredients work effectively.
  • UNII 2UMI9U37CP
    Oleic acid is a naturally occurring fatty acid derived from plant or animal oils. It functions as an emulsifier and solvent in medicines, helping blend water and oil-based ingredients together and dissolving other components.
  • UNII A7F3N56197
    Polysorbate 85 is a man-made emulsifier and solubilizer derived from sorbitol and oleic acid. It helps keep oils and water mixed together in liquid medicines and allows poorly soluble ingredients to dissolve evenly throughout the formulation.
  • UNII 6Y8XYV2NOF
    A waxy substance made by honeybees from plant resins and pollen. In medicines, it acts as a binder and coating agent to hold ingredients together and protect the product.
  • UNII M6S840WXG5
    Purslane is a plant-derived ingredient used in pharmaceuticals as a natural source of beneficial compounds. It functions as an antioxidant and anti-inflammatory agent to help stabilize the formula and support product shelf life.
  • UNII G025DAL7CE
    A plant extract from rhubarb root used as a natural colorant and flavoring agent in medicines. It may also help stimulate bowel movement in laxative formulations.
  • UNII R60QEP13IC
    Rice bran is a natural powder made from the outer layer of rice grains. It's used in medicines as a filler and flow agent to add bulk and help the product mix and flow smoothly during manufacturing.
  • UNII 66H9NW427Y
    A natural extract from the soapberry fruit used as a cleansing agent and surfactant in topical formulations. It helps distribute active ingredients evenly and may serve as a natural preservative or emulsifier in the product.
  • UNII W7Q5E87674
    Sodium cocoamphoacetate is a mild cleansing agent derived from coconut oil. In medicines, it acts as an emulsifier and surfactant to help mix oil and water-based ingredients together and improve product texture and consistency.
  • UNII R1TQH25F4I
    Sodium cocoate is a salt derived from coconut oil. It acts as an emulsifier and surfactant in medicines, helping to mix ingredients that normally don't blend together and improve product texture and stability.
  • 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.

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

The official label also statesWater Hydroxyethylcellulose Black Strap Powder Mandelic Acid Disodium EDTA Oleic Acid Lauryl Glucoside Butylene Glycol Diglycerin Sodium Cocoate Cocamide MIPA sh-Oligopeptide-1 Acetyl Hexapeptide-8 Shea Butteramidopropyl Betaine Sodium Cocoamphoacetate Oryza Sativa (Rice) Bran Extract Artemisia Vulgaris Extract Phaseolus Radiatus Seed Extract Centella Asiatica Extract Portulaca Oleracea Extract Crataegus Oxyacantha Extract Rheum Palmatum Root Extract Bambusa Vulgaris Extract Eucalyptus Globulus Leaf Extract Hamamelis Virginiana (Witch Hazel) Extract Chamomilla Recutita (Matricaria) Flower/Leaf Extract Propolis Extract Sapindus Mukorossi Fruit Extract Panax Ginseng Root Extract Polysorbate 85 1,2-Hexanediol Caprylic/Capric Triglyceride Fragrance

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerPARMA KOREA
Labeler code71614
First marketedAug 2018
Product typeHuman Otc Drug
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 2 words ▾

Anus Cleansing

⏱️ Dosage and Administration 26 words ▾

Wet anal area thoroughly. Apply an appropriate amount of the product to anal area. Massage anus and maintain 30 seconds. Rinse with water for 60 seconds.

⚠️ Warnings 28 words ▾

For external use only. Do not use on damaged or broken skin. Rinse with water to remove. Stop use and ask a doctor if rash or irritation occurs.

🧪 Active Ingredient 2 words ▾

Allantoin 0.3%

🧪 Inactive Ingredients 86 words ▾

Water Hydroxyethylcellulose Black Strap Powder Mandelic Acid Disodium EDTA Oleic Acid Lauryl Glucoside Butylene Glycol Diglycerin Sodium Cocoate Cocamide MIPA sh-Oligopeptide-1 Acetyl Hexapeptide-8 Shea Butteramidopropyl Betaine Sodium Cocoamphoacetate Oryza Sativa (Rice) Bran Extract Artemisia Vulgaris Extract Phaseolus Radiatus Seed Extract Centella Asiatica Extract Portulaca Oleracea Extract Crataegus Oxyacantha Extract Rheum Palmatum Root Extract Bambusa Vulgaris Extract Eucalyptus Globulus Leaf Extract Hamamelis Virginiana (Witch Hazel) Extract Chamomilla Recutita (Matricaria) Flower/Leaf Extract Propolis Extract Sapindus Mukorossi Fruit Extract Panax Ginseng Root Extract Polysorbate 85 1,2-Hexanediol Caprylic/Capric Triglyceride Fragrance

🎯 Purpose 2 words ▾

Skin Protectant

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children

📄 Package Label / Principal Display Panel 2 words ▾

image description

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

About this NDC listing & data coverage

Over-the-counter (OTC) product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 "Unapproved Drug Other". 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 PARMA KOREA. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PARMA KOREA 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.
← 71613-0001-01 · Nextcell 71617-0100-10 · SRL →
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.