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OKeeffes Skin Repair Body Cream Eczema Relief Colloidal Oatmeal 2 g/100g Cream, 198 g

by The Gorilla Glue Company/O'Keeffe's Company · 198 g in 1 TUBE (71564-010-98)
NDC 71564-0010-98
🏷️ FDA NDC (as labeled) 71564-010-98 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) 71564-010-98
Product NDC 71564-010
11-digit billing NDC 71564001098
RxCUI 1189915
UNII 8PI54V663Y
Application # M016
SPL Set ID 39e9ca98-d0e6-6b8f-e063-6394a90aa366
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 2025-09-01
Route TOPICAL
Dosage form CREAM
Substance OATMEAL
Why two NDCs? The FDA registers this code as 71564-010-98 — 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 → 71564-0010-98. 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

LabelerThe Gorilla Glue Company/O'Keeffe's Company
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code71564
First marketedSep 2025
Product typeHuman Otc Drug
Portfolio5 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?

This is a topical cream containing colloidal oatmeal, marketed as an over-the-counter monograph drug for eczema relief. Colloidal oatmeal is commonly used in skin-care products to help soothe and moisturize irritated or dry skin. The product is applied directly to affected areas of the body as a skin repair treatment. It appears in this OTC drug category based on the ingredient's traditional use in managing minor skin irritation and dryness.

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 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 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 I9PJ0O6294
    A modified starch derived from corn or potato starch with aluminum salt and octenylsuccinic acid added. It acts as a binder to hold tablet ingredients together and as a thickening agent in liquid formulations.
  • UNII WL3883U2PO
    A natural resin derived from the caesalpinia spinosa plant, used as a binder and film-forming agent to help hold tablet ingredients together and create a protective coating on the medicine's surface.
  • 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 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 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 9E4CO0W6C5
    A silicone-based polymer that forms soft, spongy particles. Used as a texture modifier and suspending agent to improve how the product feels and flows, and to help keep ingredients evenly distributed throughout the formulation.
  • UNII OM9573ZX3X
    A synthetic compound used as an antistatic agent and conditioner in solid dosage forms. It reduces friction and helps powders flow smoothly during manufacturing and tablet compression.
  • 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 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 C5529G5JPQ
    Ginger is a plant-derived ingredient used as a flavoring agent to add taste and aroma to medicines. It may also provide mild soothing properties to support product palatability.
  • 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII OAH19558U1
    A synthetic compound made from coconut oil, laureth-12 helps mix oil and water-based ingredients together. It acts as an emulsifier and surfactant in formulations, improving how the medicine spreads and is absorbed.
  • UNII N72LMW566G
    A synthetic cleansing agent derived from lauryl alcohol and ethylene oxide. It helps dissolve and mix oil and water-based ingredients in liquid medicines, acting as an emulsifier and solubilizer.
  • UNII 6HQ855798J
    Laureth-4 is a synthetic detergent made from lauryl alcohol and ethylene oxide. It acts as an emulsifier and solubilizer, helping blend oil and water-based ingredients and improve how the body absorbs the active drug.
  • UNII 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • 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 YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • 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 YRC528SWUY
    A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
  • UNII GMR4PEN8PK
    A synthetic polymer used as a thickener and film-former in liquid formulations. It increases viscosity to improve texture and help the medicine spread or adhere evenly on the skin or mucous membranes.
  • 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 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 2ZA36H0S2V
    Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.

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

The official label also statesInactive ingredients Water, Glycerin, Cetyl Alcohol, Isopropyl Myristate, Dimethicone, Aluminum Starch Octenylsuccinate, Cetearyl Alcohol, Polysilicone-11, Ceteareth-20, Butyrospermum Parkii (Shea) Butter, Distearyldimonium Chloride, 1,2-Hexanediol, Allantoin, Caprylyl Glycol, Glyceryl Stearate, PEG-100 Stearate, Caesalpinia Spinosa Gum, Panthenol, Polyquaternium-10, Beeswax, Bisabolol, Disodium EDTA, Laureth-12, Phenoxyethanol, Laureth-23, Laureth-4, Ethylhexylglycerin, Zingiber Offcinale Root Extract

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
Cetaphil Eczema Rapid Relief Cream 2 g/100g 00299-4144-00 Galderma 227 g — — FDA listed —
TriDerma Eczema Fast Healing Face Body 2 g/100g 10738-0154-65 Genuine 170 g — — FDA listed —
Gold Bond Medicated eczema relief 20 mg/g 41167-0567-01 Chattem, 155 g — — FDA listed —
Gold Bond Eczema Relief Medicated Hand Cream 2 g/100g 41167-0668-00 Chattem, 85 g — — FDA listed —
Gold Bond Eczema Relief Medicated Skin Protectant Cream 2 g/100g 41167-0669-01 Chattem, 121 g — — FDA listed —
TCX Skincare 2 g/100g 49449-0100-01 Theraceutix, 59 g — — FDA listed —
Nizoral Eczema Relief Cream 2 g/100g 55505-0223-33 Kramer 1 bottle — — FDA listed —
Extra Strength Body 2 g/100mL 61328-0119-28 Skinfix, 236 ml — — FDA listed —
Eczema Intensive Daily Relief Body 2 g/100g 61328-0210-00 Skinfix, 177 g — — FDA listed —
The Indigo Calming 20 mg/mL 69417-0140-03 TATCHA 1 jar — — Discontinued —
CLn Body Moisturizer 2 g/100g 69530-0858-01 TopMD 30 g — — FDA listed —
Aveeno Eczema Therapy Rescue Relief Treatment 20 mg/mL 69968-0802-01 Kenvue 14 ml — — FDA listed —
Aveeno Eczema Therapy Rescue Relief Treatment Gel Cream 20 mg/g 69968-1003-02 Kenvue 44 g — — FDA listed —
OKeeffes Skin Repair Body Cream Eczema Relief 2 g/100gthis 71564-0010-98 The 198 g — — FDA listed —
Eczema Reliegf Skin Protectant EQB 2 g/100g 79903-0209-08 Walmart 226 g — — FDA listed —
Dermoia Manuka Honey Eczema 20 mg/mL 83524-0607-00 TREASUREWISE 120 ml — — FDA listed —
Gold Bond Medicated eczema relief 20 mg/g 84714-0567-01 Gold 155 g — — FDA listed —
Gold Bond Eczema Relief Medicated Hand Cream 2 g/100g 84714-0668-00 Gold 85 g — — FDA listed —
Gold Bond Eczema Relief Medicated Skin Protectant Cream 2 g/100g 84714-0669-01 Gold 121 g — — FDA listed —
Soteri Skin Baby Eczema Relief Cream 2 g/100mL 85265-0104-01 Soteri 1 bottle — — FDA listed —
Everyday Eczema 2 g/100g 54136-0181-25 Better 244 g — — FDA listed —
Evereden Intensive Eczema Balm 2 g/100g 72113-0109-21 Eden 1 jar — — FDA listed —
Calming Itch and Irritation 2 g/100g 54136-0183-24 Better 239 g — — FDA listed —
Eczema Skin Relief Cream 2 g/100g 51316-0860-01 CVS 227 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
Sep 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.

🔬 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 OKeeffes Skin Repair Body Cream Eczema Relief (this brand).

Top reported reactions

Rash2
Anaemia1
Aplastic Anaemia1
Asthenia1
Bile Duct Stenosis1
Cholangiocarcinoma1
Death1

Age at onset

Adult2

Reporter sex

11 reports
Male · 50%
Female · 50%

Serious outcomes

Life-threatening1
Death1
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 2 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71564-0010-98 You're viewing this 198 g in 1 TUBE (71564-010-98) 2025-09-01 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 — Not published for this NDC No photo available yet for this listing.
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 71564-010-98, 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: 71564-0010-98, written without dashes as 71564001098. 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 71564-0010-98, the first segment (71564) is the labeler code FDA assigned to The Gorilla Glue Company/O'Keeffe's Company; the middle segment (0010) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (98) 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 Gorilla Glue Company/O'Keeffe's Company. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
The Gorilla Glue Company/O'Keeffe's Company 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 relieve minor skin irritation and itching due to: rashes eczema poison ivy, oak, or sumac insect bites

⏱️ Dosage and Administration 4 words ▾

Directions apply as needed

⚠️ Warnings 5 words ▾

Warnings For external use only

🧪 Active Ingredient 5 words ▾

Active ingredient Colloidal oatmeal 2%

🧪 Inactive Ingredients 48 words ▾

Inactive ingredients Water, Glycerin, Cetyl Alcohol, Isopropyl Myristate, Dimethicone, Aluminum Starch Octenylsuccinate, Cetearyl Alcohol, Polysilicone-11, Ceteareth-20, Butyrospermum Parkii (Shea) Butter, Distearyldimonium Chloride, 1,2-Hexanediol, Allantoin, Caprylyl Glycol, Glyceryl Stearate, PEG-100 Stearate, Caesalpinia Spinosa Gum, Panthenol, Polyquaternium-10, Beeswax, Bisabolol, Disodium EDTA, Laureth-12, Phenoxyethanol, Laureth-23, Laureth-4, Ethylhexylglycerin, Zingiber Offcinale Root Extract

🎯 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 ↗
← 71564-0009-03 · The 71564-0011-22 · 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.