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Prequel Skin Utility Balm Multi-Purpose Skin Protectant 5.25 mg/g Ointment — NDC 82800-0060-01 package photo

Prequel Skin Utility Balm Multi-Purpose Skin Protectant 5.25 mg/g Ointment

by The Center Brands, LLC · 1 TUBE in 1 PACKAGE (82800-060-01) / 50 g in 1 TUBE
NDC 82800-0060-01
🏷️ FDA NDC (as labeled) 82800-060-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 82800-060-01
Product NDC 82800-060
11-digit billing NDC 82800006001
UNII 92RU3N3Y1O
Application # M016
SPL Set ID 57c0b71d-6099-415c-976d-b96d2f73e9d3
Physiologic effect Skin Barrier Activity
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-10-30
Route TOPICAL
Dosage form OINTMENT
Substance DIMETHICONE
Why two NDCs? The FDA registers this code as 82800-060-01 — 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 → 82800-0060-01. 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.

🏭 Manufacturer & labeler

LabelerThe Center Brands, LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code82800
First marketedOct 2023
Product typeHuman Otc Drug
Portfolio14 products on file
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.

🩺 Clinical

🧪 What is this product?

Prequel Skin Utility Balm is an over-the-counter topical ointment that functions as a skin protectant. The product contains dimethicone, a silicone-based ingredient commonly used in skin care products to form a water-repellent barrier on the skin surface. This type of balm is typically used to help protect and moisturize areas of skin that may be irritated or require a protective coating.

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.

🧪 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 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 W59H9296ZG
    A synthetic polymer made from acrylic compounds and vinylpyrrolidone. It works as a film-former and thickener in topical products, helping create a smooth texture and improve how the medication spreads on skin.
  • UNII 0C9AC7D6XU
    A plant-derived fat from shea nut kernels that remains after soap-making. It acts as a moisturizer, emollient, and texture enhancer in topical formulations, helping soften skin and improve product spreadability.
  • UNII 5077EL0C60
    A plant extract from camellia leaves used in formulations as an antioxidant and skin-conditioning agent. It helps protect the product and its active ingredients from degradation.
  • UNII UPY805K99W
    A synthetic compound derived from caprylic acid that works as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the medicine.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • 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 4370DF050B
    Ceramide NP is a waxy, lipid-based substance that mimics natural skin oils. It's used in topical formulations as an emollient and skin-conditioning agent to help soften, smooth, and protect the skin barrier.
  • UNII 58B69Q84JO
    A plant-derived emulsifier made from olive oil and fatty alcohols. It helps blend oil and water ingredients together and stabilizes the product's texture in creams, lotions, and similar formulations.
  • UNII 60F80Z61A9
    A fragrant plant oil extracted from chamomile flowers. It's used as a flavoring agent and fragrance in medicines to improve taste and smell, making the product more pleasant to take.
  • UNII 97C5T2UQ7J
    Cholesterol is a fatty substance found naturally in animal tissues. In medications, it's used as an ingredient in liposomal formulations and lipid-based drug delivery systems to help encapsulate and stabilize active drugs for better absorption.
  • UNII DSO12WL7AU
    A salt derived from citric acid, this ingredient acts as a buffer and pH regulator in medicines. It helps maintain stable acidity levels and may improve taste or aid preservation.
  • UNII WTF09990PK
    A waxy, fatty substance derived from stearic acid and dipentaerythritol. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
  • 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 ZBX50UG81V
    A salt derived from phytic acid, a natural compound found in plants. In medications, it functions as a chelating agent and buffering substance, helping to stabilize formulations and control pH levels.
  • UNII U333RI6EB7
    Hydrogenated polydecene type I is a synthetic oil derived from plant-based polymers. It acts as a lubricant and glidant to help powder ingredients flow smoothly during tablet or capsule manufacturing.
  • UNII H1109Z9J4N
    A natural emulsifier derived from soybean oil. It helps mix oil and water-based ingredients together, ensuring even distribution of active ingredients throughout the medicine.
  • UNII 0IK29C4889
    A light, clear liquid derived from isosorbide and caprylic acid. It acts as a solvent and penetration enhancer, helping dissolve active ingredients and improve skin absorption in topical formulations.
  • UNII 33X04XA5AT
    Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
  • UNII QU7U88D04I
    Laureth-8 is a synthetic ingredient made from lauryl alcohol and ethylene oxide. It acts as an emulsifier and surfactant, helping blend water and oil-based components together in liquid formulations.
  • 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 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 GIN46U9Q2Q
    Phytosphingosine is a naturally derived fatty compound that helps stabilize and thicken skincare and cosmetic formulations. It works as an emollient and conditioning agent to improve texture and skin feel in topical products.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 1DXE3F3OZX
    A synthetic polymer that forms a gel-like network. It absorbs and holds water, thickens the medicine, and helps keep ingredients evenly mixed throughout the formulation.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 0YPR65R21J
    Sodium sulfate is a mineral salt used in pharmaceuticals as a filler and diluent. It helps provide bulk and stability to tablets and capsules while remaining inert in the body.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 76N22HKP3X
    A synthetic liquid solvent derived from acetic acid and tert-butanol. It helps dissolve or carry active ingredients and other components in liquid or semi-solid formulations, improving how the medicine spreads or applies.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII JV0QT00NUE
    Undecane is a clear liquid hydrocarbon derived from petroleum. It functions as a solvent and processing aid in medicines, helping dissolve or suspend active ingredients and improve how the drug is manufactured and delivered.
  • 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.

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

The official label also statesWater (Aqua), Propanediol, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Undecane, Glycerin, Dipentaerythryityl Hexahydrostearate/Hexastearate/Hexarosinate, Isosorbate Dicaprylate, Cetearyl Olivate, Tridecane, Sorbitan Olivate, Silica, Ceramide NP, Cholesterol, Phytospingosine, Hydrogentaed Lecithin, Centella Asiatica Extract, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ammonium Acryloyldimethyltuarate/VP Copolymer, Hydrogenated Polydecene, Xanthan Gum, Stearic Acid, Sodium Phytate, Tocopheryl Acetate, Camomilla Recutita Flower Extract, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Ethylhexylglycerin, Citric Acid, Caprylic/Capric Trigylceride, Lactic Acid, Oleic Acid, Laureth-8, Caprylyl Glycol, Caprylhydroxamic Acid, Tocopherol, Potassium Sorbate, Sodium Benzoate, Sodium Sulfate, t-Butyl Acohol

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.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Prequel Skin Utility Balm Multi-Purpose Skin Protectant 5.25 mg/gthis 82800-0060-01 The 1 tube — — 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

🏛️
2023
On the market since
Oct 2023
📍
2026
Currently FDA-listed
3 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
82800-0060-01 You're viewing this 1 TUBE in 1 PACKAGE (82800-060-01) / 50 g in 1 TUBE 2023-10-30 Active

🧭 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 FDA registers it as 82800-060-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 82800-0060-01, written without dashes as 82800006001. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 82800-0060-01, the first segment (82800) is the labeler code FDA assigned to The Center Brands, LLC; the middle segment (0060) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
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 The Center Brands, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
The Center Brands, LLC 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.

📄 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
🎯 Indications and Usage 22 words ▾

Uses Temporarily protects and helps releive chafed, chapper or cracked skin Helps protect fomr the drying effects of wind and cold weather

⏱️ Dosage and Administration 4 words ▾

Directions Apply as needed.

⚠️ Warnings 39 words ▾

Warnings Fox external use only. When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days

🧪 Active Ingredient 4 words ▾

Active Ingredients Dimethicone 5.25%

🧪 Inactive Ingredients 82 words ▾

Inactive ingredients Water (Aqua), Propanediol, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Undecane, Glycerin, Dipentaerythryityl Hexahydrostearate/Hexastearate/Hexarosinate, Isosorbate Dicaprylate, Cetearyl Olivate, Tridecane, Sorbitan Olivate, Silica, Ceramide NP, Cholesterol, Phytospingosine, Hydrogentaed Lecithin, Centella Asiatica Extract, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ammonium Acryloyldimethyltuarate/VP Copolymer, Hydrogenated Polydecene, Xanthan Gum, Stearic Acid, Sodium Phytate, Tocopheryl Acetate, Camomilla Recutita Flower Extract, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Ethylhexylglycerin, Citric Acid, Caprylic/Capric Trigylceride, Lactic Acid, Oleic Acid, Laureth-8, Caprylyl Glycol, Caprylhydroxamic Acid, Tocopherol, Potassium Sorbate, Sodium Benzoate, Sodium Sulfate, t-Butyl Acohol

🎯 Purpose 3 words ▾

Purpose Skin Protectant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 82800-0030-01 · The 82800-0070-01 · The →
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.