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AN12 Skin Therapy Vita-B Aloe Soothing Gel Glycerin 2 g/100mL Gel, 300 mL — NDC 82385-0104-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

AN12 Skin Therapy Vita-B Aloe Soothing Gel Glycerin 2 g/100mL Gel, 300 mL — NDC 82385-104-01 (Billing 82385-0104-01)

by BESTVALUE Co., Ltd · 300 mL in 1 BOTTLE, PUMP

This is a package of 300 mL of AN12 Skin Therapy Vita-B Aloe Soothing Gel Glycerin 2 g/100mL Gel from BESTVALUE Co., Ltd, marketed since Dec 2021 and currently FDA-listed. It is this product's only package size.

NDC 82385-0104-01
🏷️ FDA NDC (as labeled) 82385-104-01 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 82385-104-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
82385 labeler · 104 product · 01 package
Package marketed since
Dec 6, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
8809478290171
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Glycerin (different manufacturers) — 4 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 27, 2026 — Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision. (Oasis Medical, Inc.) · FDA recall D-0525-2026
Class II · Apr 20, 2026 — Lack of Assurance of Sterility (SCOPE HEALTH) · FDA recall D-0499-2026
Class II · Mar 25, 2026 — Lack of Assurance of Sterility (Preferred Pharmaceuticals, Inc.) · FDA recall D-0443-2026
Class II · Mar 3, 2026 — Lack of Assurance of Sterility (K.C. Pharmaceuticals, Inc) · FDA recall D-0411-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 82385-104-01
Product NDC 82385-104
11-digit billing NDC 82385010401
RxCUI 2586849
UNII PDC6A3C0OX
UPC 8809478290171
SPL Set ID d274c973-057d-1c9f-e053-2995a90a82b1
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 2021-12-06
Route TOPICAL
Dosage form GEL
Substance GLYCERIN
Quick answers
  • RxCUI (RxNorm): 2586849
Why two NDCs? The FDA registers this code as 82385-104-01 — 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 → 82385-0104-01. 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 Non-Standardized Chemical Allergen class.

Pharmacologic class Non-Standardized Chemical Allergen
Drug family (ATC) Enemas, Other drugs for constipation
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

🧪 What is this product?

AN12 Skin Therapy Vita-B Aloe Soothing Gel is a topical gel containing glycerin as its active ingredient. Glycerin is commonly used in skin care products as a humectant, meaning it helps draw moisture into the skin and is typically used to soften and hydrate the skin surface. This product is marketed as an unapproved drug and has not received FDA approval through a standard application process.

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
82385-0104-01 You're viewing this Main listing 300 mL in 1 BOTTLE, PUMP 2021-12-06 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
AN12 Skin Therapy Vita-B Aloe Soothing Gel 2 g/100mLthis 82385-0104-01 BESTVALUE 300 ml — — FDA listed —
Zenibell Snail Intensive 2 g/100mL 73466-0001-01 MISOCOS 150 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
Dec 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 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 ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 94ZLA3W45F
    Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid formulations.
  • 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 7OL154J5XB
    A plant extract from the leaves of Hinoki cypress, a tree species native to Japan. It may be used in formulations for fragrance, flavor, or as a natural preservative or antioxidant component.
  • 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 E89I1637KE
    Guar gum is a natural thickener made from guar bean seeds. It's used in medicines as a binder and thickening agent to hold ingredients together and create the right texture and consistency.
  • UNII VYT2JA85NH
    A plant extract from cogon grass roots used in some formulations. It may serve as a natural filler, thickening agent, or ingredient to help bind tablet components together.
  • UNII 1PRR1V42V5
    A beneficial bacterium sometimes added to medicines and supplements. It may serve as a probiotic ingredient intended to support digestive health, though in a medicine it functions mainly as an active component rather than a traditional inactive filler or binder.
  • UNII ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII G0R4UBI2ZZ
    Matricaria chamomilla, commonly known as chamomile, is a plant extract used in medicines as a flavoring agent and natural fragrance component. It may also provide mild soothing properties to the formulation.
  • UNII 0E5AT8T16U
    Origanum vulgare leaf is dried oregano plant material used as a natural flavor and aroma ingredient in medicines. It may also provide antioxidant properties to help preserve the product.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • UNII FY35I16MPL
    A plant extract from pulsatilla koreana root used in traditional herbal preparations. In medicines, it may serve as an active botanical ingredient or flavoring component, though its specific formulation role depends on the product type.
  • UNII 205MXS71H7
    A plant extract from white willow bark. It's used as a natural flavoring agent and may help preserve the medicine by providing mild antioxidant properties in the formulation.
  • UNII 7J95K7ID2S
    A plant extract from the roots of Chinese skullcap, used as a natural coloring agent and to add mild flavor to medicines. It may also help preserve the product's stability.
  • 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 D6DVA9TCAP
    Usnea barbata is a lichen, a fungus-algae organism, used as a natural fragrance or flavoring agent in some medicines. It may also serve as a botanical extract with mild preservative properties.
  • UNII BK9092J5MP
    A plant extract from mistletoe that thickens liquid formulations and may help ingredients stay evenly mixed. It serves as a viscosity enhancer and stabilizer in medicines.
  • 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 7PFC2VA251
    A plant-derived substance from the fruit of Zanthoxylum piperitum, commonly called Japanese pepper. It's used as a flavoring agent to improve taste and mask bitter flavors in the medicine.

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

The official label also statesAloe Barbadensis Leaf Water, Lavandula Angustifolia (Lavender) Water, Propanediol, Chamomilla Recutita (Matricaria) Extract, Water, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract, Salix Alba (Willow) Bark Extract, Cinnamomum Cassia Bark Extract, Origanum Vulgare Leaf Extract, Chamaecyparis Obtusa Leaf Extract, Scutellaria Baicalensis Root Extract, Portulaca Oleracea Extract, Saccharomyces/Viscum Album (Mistletoe) Ferment Extract Saccharomyces/Imperata Cylindrica Root Ferment Extract, Camellia Sinensis Leaf Extract, Carbomer, Arginine, Panthenol, Allantoin, Cyamopsis Tetragonoloba (Guar) Gum, Xanthan Gum

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 marketedDec 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 📦 Storage and Handling 🧪 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 18 words ▾

Directions Take out an appropriate amount, spread it evenly on your skin, and tap lightly to absorb it.

⏱️ Dosage and Administration 26 words ▾

Uses It permeates the skin without stickiness and provides rich nutrition to the skin to help skin elasticity, skin sedation, skin moisturization, and prevention of aging.

⚠️ Warnings 9 words ▾

Warnings Do not use for other than intended purpose

📦 Storage and Handling 7 words ▾

Warnings Keep it away from direct sunlight.

🧪 Active Ingredient 4 words ▾

Active Ingredient Glycerin 2%

🧪 Inactive Ingredients 75 words ▾

Inactive Ingredients Aloe Barbadensis Leaf Water, Lavandula Angustifolia (Lavender) Water, Propanediol, Chamomilla Recutita (Matricaria) Extract, Water, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract, Salix Alba (Willow) Bark Extract, Cinnamomum Cassia Bark Extract, Origanum Vulgare Leaf Extract, Chamaecyparis Obtusa Leaf Extract, Scutellaria Baicalensis Root Extract, Portulaca Oleracea Extract, Saccharomyces/Viscum Album (Mistletoe) Ferment Extract Saccharomyces/Imperata Cylindrica Root Ferment Extract, Camellia Sinensis Leaf Extract, Carbomer, Arginine, Panthenol, Allantoin, Cyamopsis Tetragonoloba (Guar) Gum, Xanthan Gum

🎯 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 18 words ▾

Warnings Stop use and consult a specialist If you have symptoms such as red spots, swelling, itching, etc.

📄 Keep Out of Reach of Children 8 words ▾

Warnings Keep it out of reach of children.

📄 Package Label / Principal Display Panel 10 words ▾

Display Panel Label AN12 Skin Therapy Vita-B Aloe Soothing Gel

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 AN12 Skin Therapy Vita-B Aloe Soothing Gel (this brand).

Top reported reactions

Macular Degeneration598
Constipation440
Pain400
Nausea322
Pyrexia308
Malaise275
Weight Decreased268

Age at onset

Neonate3
Infant8
Child11
Adolescent7
Adult144
Elderly323

Reporter sex

2,561 reports
Male · 34%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization1,397
Death364
Disabling50
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 470 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 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.
← 82385-0103-01 · BESTVALUE 82388-0001-01 · LIVENT →
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.