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Atopis Eczema Therapy Cream Colloidal Oatmeal .5 g/100g Cream — NDC 71570-0001-01 package photo

Atopis Eczema Therapy Cream Colloidal Oatmeal .5 g/100g Cream

by Bionona Limited · 1 BOTTLE in 1 CARTON (71570-001-01) / 75 g in 1 BOTTLE
NDC 71570-0001-01
🏷️ FDA NDC (as labeled) 71570-001-01 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) 71570-001-01
Product NDC 71570-001
11-digit billing NDC 71570000101
RxCUI 1654149
UNII 8PI54V663Y
UPC 0735850153957
Application # M016
SPL Set ID 8d4b4a14-b631-f2fa-e053-2a95a90a932f
Established class (EPC) Non-Standardized Food Allergenic Extract; Non-Standardized Plant Allergenic Extract
Physiologic effect Increased Histamine Release; Cell-mediated Immunity
Chemical class Allergens; Dietary Proteins; Plant Proteins
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-07-15
Route TOPICAL
Dosage form CREAM
Substance OATMEAL
Why two NDCs? The FDA registers this code as 71570-001-01 — 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 → 71570-0001-01. 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.

🏷️ RxNorm drug class

This medicine belongs to the Non-Standardized Food Allergenic Extract class.

Pharmacologic class Non-Standardized Food Allergenic Extract, Non-Standardized Plant Allergenic Extract
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.

🏭 Manufacturer & labeler

LabelerBionona Limited
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code71570
First marketedJul 2019
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.

🩺 Clinical

🧪 What is this product?

Atopis Eczema Therapy Cream is a topical over-the-counter cream containing colloidal oatmeal as its active ingredient. Colloidal oatmeal is commonly used in skin care products to help soothe and moisturize irritated or dry skin. This product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for its ingredient category rather than undergoing individual product review. The cream is applied directly to the skin to address eczema-related dryness and irritation.

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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 3729L8MA2C
    Bee pollen is a granular mixture collected by honeybees from flowers. It's used in medicines as a natural filler and binder to help hold tablet or capsule ingredients together and add bulk to the formulation.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 39W1PKE3JI
    Bergamot oil is a citrus extract from bergamot orange peel. It's used as a flavoring and fragrance agent to improve taste and aroma in medicines.
  • 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 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII 267F5Y81NT
    Coconut water is a natural liquid from inside coconut fruits. It's used in medicines as a vehicle or solvent to help dissolve and deliver active ingredients, and sometimes as a flavor or sweetening agent.
  • UNII 2KAG279R6R
    Dehydroacetic acid is a synthetic preservative that prevents mold, yeast, and bacterial growth in medicines. It extends shelf life by protecting the product from spoilage during storage and use.
  • 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 RN8P45F92A
    A natural fruit extract from honeydew melon, used primarily as a flavoring agent to make the medicine taste more pleasant and improve palatability for patients.
  • UNII 515610SU8C
    Macadamia oil is a plant-derived oil extracted from macadamia nuts. In medicines, it serves as an emollient and solvent to help dissolve or suspend active ingredients and improve product texture and absorption.
  • UNII 65UEH262IS
    Safflower oil is a plant-based oil extracted from safflower seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients, and sometimes as an emollient to improve texture.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII 65A9F4P024
    A synthetic compound derived from the amino acid glutamate and stearic acid. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients, keeping the medicine uniform throughout.
  • UNII MDL271E3GR
    Sorbitan olivate is an emulsifier derived from sorbitol and olive oil. It helps blend water and oil ingredients together to maintain consistent texture and appearance throughout the medicine.
  • 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.

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

The official label also statesMyriphytase extract (Cocos nucifera (coconut) water, Bee pollen, Cocos nucifera coconut) oil, Notofagus fuca honeydew), Cetearyl olivate, Sorbitan olivate, Carthamus tinctorius (Safflower) seed oil, Cetearyl alcohol, Glycerin, Macadamia ternifolia seed oil, Butyrospermum parkii (shea butter), Tocopheryl acetate, Sodium stearoyl glutamate, benzyl alcohol, dehydracetic acid, Citrus aurantium bergamia (bergamot) fruit oil, Xanthan gum, Citric acid.

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
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant .5 g/100g 10637-1901-01 Port 28.3 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant .5 g/100g 69423-0556-11 The 113.4 g — — Discontinued —
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Vanilla .5 g/100g 69423-0563-39 The 396.8 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant White Tea and Apricot .5 g/100g 69423-0564-39 The 396.8 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Cranberry Pomegranate .5 g/100g 69423-0565-39 The 396.8 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Pink Grapefruit .5 g/100g 69423-0567-34 The 340.2 g — — FDA listed —
Olay Sensitive Soothing Moisturizer Skin Protectant Fragrance-Free .5 g/100g 69423-0700-15 The 1 jar — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla Cookie .5 g/100g 69423-0708-56 The 56.7 g — — FDA listed —
Atopis Eczema Therapy Cream .5 g/100gthis 71570-0001-01 Bionona 1 bottle — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Birthday Hydration .5 g/100g 84126-0043-56 The 56.7 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Winter Mint .5 g/100g 84126-0044-56 The 56.7 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Peppermint Twist .5 g/100g 84126-0046-01 The 2 jars — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla Latte .5 g/100g 84126-0047-56 The 56.7 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Vanilla Cinnamon .5 g/100g 84126-0048-01 The 2 jars — — FDA listed —
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Winter Citrus .5 g/100g 84126-0049-01 The 2 jars — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Candy Cane .5 g/100g 84126-0100-56 The 56.7 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Cucumber Melon .5 g/100g 84126-0102-39 The 396.8 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Juicy Peach .5 g/100g 84126-0104-39 The 396.8 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Fresh Strawberry .5 g/100g 84126-0105-39 The 396.8 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant .5 g/100g 84126-0203-11 The 113 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Sparkling Grapefruit .5 g/100g 84126-0210-39 The 396.8 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Sugar Cookie .5 g/100g 84126-0211-39 The 396.8 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Chai Cinnamon .5 g/100g 84126-0212-39 The 396.8 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Warm Vanilla .5 g/100g 84126-0213-34 The 340.2 g — — FDA listed —
First Aid Beauty Dry Skin Rescue Kit 84126-0220-01 The 1 kit — — FDA listed —
Pink Eczema Cream .5 g/100g 87043-0012-02 MOOGOO 100 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Body Skin Protectant .5 g/100g 69423-0726-28 The 283.5 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Body Skin Protectant Cooling Cucumber .5 g/100g 69423-0727-28 The 283.5 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Toasted Coconut .5 g/100g 84126-0284-39 The 396.8 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Frosted Grapefruit .5 g/100g 84126-0282-39 The 396.8 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Summer Grapefruit .5 g/100g 84126-0281-39 The 396.8 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Cream Skin Protectant Velvet Plum .5 g/100g 84126-0283-39 The 396.8 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

🏛️
2019
On the market since
Jul 2019
📍
2026
Currently FDA-listed
7 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
71570-0001-01 You're viewing this 1 BOTTLE in 1 CARTON (71570-001-01) / 75 g in 1 BOTTLE 2019-07-15 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 71570-001-01, 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: 71570-0001-01, written without dashes as 71570000101. 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 71570-0001-01, the first segment (71570) is the labeler code FDA assigned to Bionona Limited; the middle segment (0001) 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 Bionona Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bionona Limited 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 19 words ▾

temporarily protects and helps relieve minor skin irritation and itching due to • rashes • eczema • insect bites

⏱️ Dosage and Administration 6 words ▾

Apply twice daily for best results.

⚠️ Warnings 60 words ▾

For 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 46 words ▾

• Safe for the face and body. • External use only. If irritation should occur discontinue use. • When using this product you may notice a slight tingling sensation; this is normal and will subside. • Do not use if quality seal is broken or missing.

🧪 Active Ingredient 3 words ▾

Colloidal Oatmeal 0.5%

🧪 Inactive Ingredients 54 words ▾

Myriphytase extract (Cocos nucifera (coconut) water, Bee pollen, Cocos nucifera coconut) oil, Notofagus fuca honeydew), Cetearyl olivate, Sorbitan olivate, Carthamus tinctorius (Safflower) seed oil, Cetearyl alcohol, Glycerin, Macadamia ternifolia seed oil, Butyrospermum parkii (shea butter), Tocopheryl acetate, Sodium stearoyl glutamate, benzyl alcohol, dehydracetic acid, Citrus aurantium bergamia (bergamot) fruit oil, Xanthan gum, Citric acid.

🎯 Purpose 5 words ▾

Colloidal Oatmeal 0.5%...... Skin Protectant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71566-0200-08 · Pediatric 71571-0121-20 · ALCON →
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.