Home › NDC Lookup › Ingredients › Glycerin, Allantoin › 82385-0102-01
AN12 ANUS PREMIUM CLEANSER Glycerin, Allantoin 3 g/100mL; .1 g/100mL Gel, 50 mL — NDC 82385-0102-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

AN12 ANUS PREMIUM CLEANSER Glycerin, Allantoin 3 g/100mL; .1 g/100mL Gel, 50 mL — NDC 82385-102-01 (Billing 82385-0102-01)

by BESTVALUE Co., Ltd · 50 mL in 1 BOTTLE, PUMP

This is a package of 50 mL of AN12 ANUS PREMIUM CLEANSER Glycerin, Allantoin 3 g/100mL; .1 g/100mL Gel from BESTVALUE Co., Ltd, marketed since Nov 2021 and currently FDA-listed. It is this product's only package size.

NDC 82385-0102-01
🏷️ FDA NDC (as labeled) 82385-102-01 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 Aug 27, 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 82385-102-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
82385 labeler · 102 product · 01 package
Package marketed since
Nov 19, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8238510201 3
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 82385-102-01
Product NDC 82385-102
11-digit billing NDC 82385010201
UNII PDC6A3C0OX, 344S277G0Z
SPL Set ID d11b7443-2dfc-3e17-e053-2a95a90afb76
Established class (EPC) Non-Standardized Chemical Allergen
Physiologic effect Increased Histamine Release; Cell-mediated Immunity; Increased IgG Production
Chemical class Allergens; Glycerol
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-11-19
Route TOPICAL
Dosage form GEL
Substance GLYCERIN; ALLANTOIN
Why two NDCs? The FDA registers this code as 82385-102-01 — 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 → 82385-0102-01. 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.

Clinical

🧪 What is this product?

AN12 Anus Premium Cleanser is a topical gel containing glycerin and allantoin. Glycerin is commonly used in cleansing products for its ability to soften and moisturize skin, while allantoin is typically found in skincare formulations for its role in soothing and promoting skin healing. This product is marketed as an over-the-counter drug but has not received FDA approval through a standard application process.

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
82385-0102-01 You're viewing this Main listing 50 mL in 1 BOTTLE, PUMP 2021-11-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
An12 Anus Premium Cleanser 3 g/100mL; .1 g/100mLthis 82385-0102-01 BESTVALUE 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

🏛️
2021
On the market since
Nov 2021
📍
2026
Currently FDA-listed
5 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 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 PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • 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 66J7636Z2I
    A plant extract from papaya leaves used in formulations as a natural flavoring agent and to support product stability. It may also help improve the taste and appeal of the medicine.
  • 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 0W0371JRM3
    A plant extract from the flowering parts of lamb's quarters, used as a natural colorant and flavoring agent in some formulations.
  • 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 92005F972D
    A foaming and thickening agent derived from coconut oil. It's used in liquid medicines to improve texture, help distribute active ingredients evenly, and create a pleasant consistency for easier swallowing or application.
  • UNII 7W0K1TRS77
    A plant material derived from corydalis ambigua used in some formulations as a natural filler or binder. It may help hold tablet or capsule contents together and add bulk to the dosage form.
  • UNII EFX9G567MJ
    Crataegus laevigata is a plant extract commonly called hawthorn. It's used in formulations as a natural ingredient to help bind tablet components together and may contribute subtle flavor or color properties to the product.
  • UNII Z17H97EA6Y
    A plant-derived mild cleanser made from natural sugars and oils. It acts as an emulsifier and surfactant to help mix water and oil-based ingredients together in the medicine.
  • UNII 8ELE55D80G
    A plant-derived ingredient from Draba nemorosa used as a natural filler or binder in pharmaceutical formulations to help hold the tablet or capsule together and maintain its structure.
  • 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 RH041UUZ22
    A plant extract from the houttuynia cordata flower, traditionally used in Asian medicine. In formulations, it may serve as a natural flavoring, coloring, or active botanical ingredient carrier.
  • UNII T4V6TWG28D
    A plant-derived thickening agent made from cellulose. It increases viscosity and helps form a gel or paste consistency in medications, and may serve as a binder or coating material in various formulations.
  • UNII KF4TFR6V36
    A plant extract from Indian lettuce used as a natural filler and binder in medicines. It helps hold tablet or capsule ingredients together and adds bulk to the formulation.
  • 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 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 L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • 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 7YC686GQ8F
    A synthetic oily substance made from castor oil. It works as a solubilizer and emulsifier to help mix oily and water-based ingredients together in the medicine.
  • 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 56687D1Z4D
    A natural plant extract from pomegranate fruit, used as a flavor and color ingredient to enhance taste and appearance in medicines.
  • 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 L497I37F0C
    Royal jelly is a creamy, nutrient-rich secretion produced by honeybees. In medications, it serves as a natural sweetener, flavor enhancer, and ingredient that may improve taste and palatability of oral formulations.
  • 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.

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

The official label also statesWater, Cocamide DEA, Centella Asiatica Extract, Portulaca Oleracea Extract, Hamamelis Virginiana (Witch Hazel) Extract, PEG-40 Hydrogenated Castor Oil, Butylene Glycol, Artemisia Vulgaris Extract, Polysorbate 80, Oryza Sativa (Rice) Bran Extract, Phaseolus Radiatus Seed Extract, Eucalyptus Globulus Leaf Extract, Lactuca Indica Extract, Corydalis Ochotensis Extract, Draba Nemorosa Extract, Chenopodium Album Flower Extract, Lauryl Glucoside, Decyl Glucoside, Carica Papaya (Papaya) Leaf Extract, Houttuynia Cordata Extract, RH-Oligopeptide-1, Crataegus Oxyacantha Extract, Rheum Palmatum Root Extract, Bambusa Vulgaris Extract, Punica Granatum Fruit Extract, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, 1,2-Hexanediol, Hydroxyethylcellulose, Fragrance, Citric Acid, Disodium EDTA, Royal Jelly, Propolis Extract, Ascorbic Acid, Menthol

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

LabelerBESTVALUE Co., Ltd
Labeler code82385
First marketedNov 2021
Product typeHuman Otc Drug
Portfolio3 products on file

More NDCs from BESTVALUE Co., Ltd labeler code 82385

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 📄 Do Not Use 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 26 words ▾

Uses Maintaining anus cleanliness and neat condition. Removal of noxious material such as heavy metal and fluorescent material and protection of anus oil membrance without irritation.

⏱️ Dosage and Administration 63 words ▾

Directions 1. Wet your body and area around the anus with warm water. 2. Pump 2~3 times and evenly apply it to the area around the anus and then, generate bubbles with massage. 3. Gently massage with the remaining bubbles along external anus and the surrounding area and then, maintain for 30 seconds. 4. Rinse to ensure that there is no residue left.

⚠️ Warnings 9 words ▾

Warnings Do not use for other than intended purpose.

🧪 Active Ingredient 6 words ▾

Active Ingredients Glycerin 3% Allantoin 0.1%

🧪 Inactive Ingredients 99 words ▾

Inactive Ingredients Water, Cocamide DEA, Centella Asiatica Extract, Portulaca Oleracea Extract, Hamamelis Virginiana (Witch Hazel) Extract, PEG-40 Hydrogenated Castor Oil, Butylene Glycol, Artemisia Vulgaris Extract, Polysorbate 80, Oryza Sativa (Rice) Bran Extract, Phaseolus Radiatus Seed Extract, Eucalyptus Globulus Leaf Extract, Lactuca Indica Extract, Corydalis Ochotensis Extract, Draba Nemorosa Extract, Chenopodium Album Flower Extract, Lauryl Glucoside, Decyl Glucoside, Carica Papaya (Papaya) Leaf Extract, Houttuynia Cordata Extract, RH-Oligopeptide-1, Crataegus Oxyacantha Extract, Rheum Palmatum Root Extract, Bambusa Vulgaris Extract, Punica Granatum Fruit Extract, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, 1,2-Hexanediol, Hydroxyethylcellulose, Fragrance, Citric Acid, Disodium EDTA, Royal Jelly, Propolis Extract, Ascorbic Acid, Menthol

🎯 Purpose 3 words ▾

Purpose skin protectant

📄 Do Not Use 8 words ▾

Warnings Do not use on areas with scars.

📄 Stop Use and Ask a Doctor If 19 words ▾

Warnings If you have symptoms such as red spots, swelling, itching, etc. stop using them and consult a specialist.

📄 Keep Out of Reach of Children 8 words ▾

Warnings Keep it out of reach of children.

📄 Package Label / Principal Display Panel 4 words ▾

Pakage Label AN12_Display Panel

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 BESTVALUE Co., Ltd. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
BESTVALUE Co., 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.
← 82381-2174-01 · TheracosBio, 82385-0103-01 · BESTVALUE →
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.