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Glutathione Kojic Acidskin Lightening .1 g/100g; .1 g/100g; .1 g/100g; .1 g/100g Soap, 100 g — NDC 85164-0001-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Glutathione Kojic Acidskin Lightening .1 g/100g; .1 g/100g; .1 g/100g; .1 g/100g Soap, 100 g — NDC 85164-001-01 (Billing 85164-0001-01)

by HANCHOYEANBIOTEC Co.,Ltd. · 100 g in 1 BOX

This is a package of 100 g of Glutathione Kojic Acidskin Lightening .1 g/100g; .1 g/100g; .1 g/100g; .1 g/100g Soap from HANCHOYEANBIOTEC Co.,Ltd., marketed since Jan 2025 and currently FDA-listed. It is this product's only package size.

NDC 85164-0001-01
🏷️ FDA NDC (as labeled) 85164-001-01 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

NDC database record

One package, one record: these facts belong to NDC 85164-001-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
85164 labeler · 001 product · 01 package
Package marketed since
Jan 17, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8516400101 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85164-001-01
Product NDC 85164-001
11-digit billing NDC 85164000101
UNII R0ZB2556P8, GAN16C9B8O, 72VUP07IT5, PQ6CK8PD0R
Application # M016
SPL Set ID 2be274be-e6d0-d961-e063-6294a90a2190
Established class (EPC) Vitamin C
Chemical class Ascorbic Acid
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-01-17
Route TOPICAL
Dosage form SOAP
Substance TOCOPHEROL; GLUTATHIONE; ALPHA-ARBUTIN; ASCORBIC ACID
Why two NDCs? The FDA registers this code as 85164-001-01 — 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 → 85164-0001-01. 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?

This is an over-the-counter topical soap marketed as a skin-lightening product. It contains four active ingredients: alpha-arbutin, ascorbic acid (vitamin C), glutathione, and tocopherol (vitamin E). These ingredients are commonly included in products intended to address skin tone and appearance, with alpha-arbutin and ascorbic acid traditionally used in formulations targeting skin discoloration, while glutathione and tocopherol function as antioxidants. As an OTC monograph drug, this product is marketed under established FDA category rules rather than individual product 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 eachPer 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
85164-0001-01 You're viewing this Main listing 100 g in 1 BOX 2025-01-17 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Glutathione .1 g/100g; .1 g/100g; .1 g/100g; .1 g/100gthis 85164-0001-01 HANCHOYEANBIOTEC 100 g — — 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

🏛️
2025
On the market since
Jan 2025
📍
2026
Currently FDA-listed
1 year 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 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 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 6K23F1TT52
    Kojic acid is a naturally derived compound used as a preservative and antioxidant in medicines. It helps prevent spoilage and maintain product stability during storage.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII S0A6004K3Z
    Sodium palmate is a salt made from palm oil. It acts as an emulsifier and surfactant in medicines, helping mix ingredients that normally don't blend well together and improving product texture and consistency.

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

The official label also statesNONE

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

LabelerHANCHOYEANBIOTEC Co.,Ltd.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code85164
First marketedJan 2025
Product typeHuman Otc Drug
Portfolio6 products on file

More NDCs from HANCHOYEANBIOTEC Co.,Ltd. labeler code 85164

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 1 words ▾

none

⏱️ Dosage and Administration 34 words ▾

Direction of safe use 1. Rub the product between wetpalms until rich foam is formed.2. Apply the foam to face andbody, and massage gently tohelp care for the skin.3. Finally, rinse with clean water.

⚠️ Warnings 40 words ▾

Warning Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

📦 Storage and Handling 8 words ▾

warning Store in a cool and dry place.

🧪 Active Ingredient 6 words ▾

ingredients SODIUM GLYCERIN、DISODIUM EDTA、BHT、KOJIC ACID、GLUTATHIONE、ALPHA-ARBUTIN、NIACINAMIDE、ASCORBIC ACID、TOCOPHEROL

🧪 Inactive Ingredients 1 words ▾

NONE

🎯 Purpose 63 words ▾

Functions 1. Gently clean the skin surfaceand keep the skin moist andsmooth. 2. lt can whiten the skin, brightenthe complexion, reduce theformation of dark spots, andmake your skin whiter and moretranslucent. 3. The formula is mild andnon-irritating, meeting the needsof daily cleaning and care. 4. The shape of the handmadesoap fits the palm of your hand,is easy to use and has rich foam.

📄 Do Not Use 1 words ▾

none

📄 When Using This Product 15 words ▾

Warning Please clean your hands before use to ensure the best results from the product.

📄 Stop Use and Ask a Doctor If 17 words ▾

Warning Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

📄 Keep Out of Reach of Children 8 words ▾

warning Please keep out of reach of children.

📄 Package Label / Principal Display Panel 1 words ▾

label

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

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 GLUTATHIONE (this brand).

Top reported reactions

Nausea121
Hepatic Function Abnormal106
Fatigue104
Anaemia99
Platelet Count Decreased96
Headache87
Diarrhoea86

Age at onset

Neonate4
Infant3
Child11
Adolescent3
Adult212
Elderly122

Reporter sex

1,691 reports
Male · 45%
Female · 55%
Unknown · 0%

Serious outcomes

Hospitalization722
Life-threatening166
Disabling80
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 189 118
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 HANCHOYEANBIOTEC Co.,Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
HANCHOYEANBIOTEC 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.
← 85163-0027-01 · Shantou 85164-0002-01 · HANCHOYEANBIOTEC →
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.