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Crogooe Skin Relief Cream Colloidal Oatmeal 2 g/100mL Cream, 118 mL

by Guangdong Outeli Biotechnology Co., Ltd. · 118 mL in 1 BOX (87765-003-01)
NDC 87765-0003-01
🏷️ FDA NDC (as labeled) 87765-003-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 20, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 87765-003-01
Product NDC 87765-003
11-digit billing NDC 87765000301
RxCUI 1189915
UNII 8PI54V663Y
UPC 0860011519577
Application # M016
SPL Set ID 57f9b3e8-25d3-2b20-e063-6394a90aaea5
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 2026-08-01
Route CUTANEOUS
Dosage form CREAM
Substance OATMEAL
Why two NDCs? The FDA registers this code as 87765-003-01 — 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 → 87765-0003-01. 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

LabelerGuangdong Outeli Biotechnology Co., Ltd.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code87765
First marketedAug 2026
Product typeHuman Otc Drug
Portfolio2 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?

Crogooe Skin Relief Cream is an over-the-counter topical cream containing colloidal oatmeal, marketed under FDA's OTC monograph rules for skin-care products. Colloidal oatmeal is commonly used in creams applied directly to the skin to help soothe and soften irritated or dry skin. This product is intended for external use on the skin.

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 7NW19FA2G7
    A natural form of vitamin E derived from plant oils. It acts as an antioxidant to prevent oils and fats in the medicine from spoiling and maintains product stability over time.
  • 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 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 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 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 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 134647WMX4
    Cetyl ethylhexanoate is a synthetic oil used as an emollient and texture enhancer in medications. It helps soften the skin, improve spreadability, and provides a smooth feel to topical formulations.
  • UNII 2IJE0CH09J
    A brown seaweed extract used as a thickener and stabilizer in liquid medicines. It helps maintain consistent texture and prevents separation of ingredients.
  • 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 E107L85C40
    Dipropylene glycol is a clear liquid made from propylene glycol. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 6V475AX06U
    A chelating agent derived from ethylenediaminetetraacetic acid (EDTA) combined with copper. It binds metals in formulations to prevent discoloration and degradation, helping preserve the medicine's stability and appearance.
  • UNII 2865993309
    Ethylhexyl palmitate is an oily chemical made from palm oil and alcohol. It acts as an emollient and skin-conditioning agent in topical medicines, helping the product spread smoothly and keeping skin soft.
  • 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 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 TE7660XO1C
    Glycine is an amino acid used in medicines as a buffer to help stabilize pH and improve taste. It may also serve as a filler or binder to give the product proper form and consistency.
  • UNII 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII Z95S6G8201
    A synthetic surfactant derived from lauryl alcohol and ethylene oxide. It helps dissolve and mix oily and watery ingredients in liquid formulations, and may improve how the medicine spreads or is absorbed.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII 3R834EPI82
    Paeonol is an organic compound derived from peony plant extract. It functions as an antioxidant and preservative in formulations, helping protect the medicine's stability and prevent degradation over time.
  • 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 90TF85HH91
    A fatty substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water-based ingredients together in the medicine, and may also help with texture and consistency.
  • UNII Z35I17EQOP
    A waxy substance made from glycerin and stearic acid that helps stabilize and thicken cosmetic and pharmaceutical formulations. It works as an emulsifier to blend oil and water-based ingredients together.
  • UNII 9JW9D9JGHZ
    A plant extract from purslane leaves used as a natural ingredient in formulations. It may serve as an antioxidant or botanical additive to help preserve product stability and quality.
  • UNII D72A570T01
    A red seaweed extract used as a natural colorant and thickening agent. It adds color and helps create the right texture in medicines, particularly in liquid and gel formulations.
  • UNII 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • 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.

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

The official label also statesWater,Aloe Barbadensis Leaf Extract,Glycerin,Ethylhexyl Palmitate,Egg Oil,Cetyl Ethylhexanoate,Propylene Glycol,Butyrospermum Parkii (Shea) Butter,Cetearyl Alcohol,PEG-100 Stearate,Dimethicone,Polyglyceryl-6 Distearate,Polyglyceryl-10 Stearate,Cladosiphon Okamuranus Extract,Glyceryl Stearate,Polyacrylamide,Porphyra Yezoensis Extract,Simmondsia Chinensis (Jojoba) Seed Oil,Helianthus Annuus (Sunflower) Seed Oil,Sodium Hyaluronate,Tocopherol,Niacinamide,Paeonol,Portulaca Oleracea Extract,Laureth-7,Ethylhexylglycerin,Caprylhydroxamic Acid,1,2-Hexanediol,Disodium EDTA,Glycine

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
Crogooe Skin Relief Cream 2 g/100mLthis 87765-0003-01 Guangdong 118 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

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 Crogooe Skin Relief Cream (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%
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 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
87765-0003-01 You're viewing this 118 mL in 1 BOX (87765-003-01) 2026-08-01 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 87765-003-01, 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: 87765-0003-01, written without dashes as 87765000301. 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 87765-0003-01, the first segment (87765) is the labeler code FDA assigned to Guangdong Outeli Biotechnology Co., Ltd.; the middle segment (0003) 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 Guangdong Outeli Biotechnology Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Guangdong Outeli Biotechnology 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.

📄 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 3 words ▾

Relieve skin itching

⏱️ Dosage and Administration 12 words ▾

Apply generously to affected area as needed, preferably after bathing or showering

⚠️ Warnings 79 words ▾

For external use only Do notuse on deep wounds, puncture wounds, infected areas or burns. Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and consult a doctor if rash develops or irritation worsens. If symptoms do not improve within 7 days, see a healthcare provider. Keep out of reach of children.

If swallowed, get medical help or call Poison Control Center right away. If pregnant or breast-feeding, consult a health professional prior to use.

🧪 Active Ingredient 2 words ▾

Colloidal Oatmeal

🧪 Inactive Ingredients 33 words ▾

Water,Aloe Barbadensis Leaf Extract,Glycerin,Ethylhexyl Palmitate,Egg Oil,Cetyl Ethylhexanoate,Propylene Glycol,Butyrospermum Parkii (Shea) Butter,Cetearyl Alcohol,PEG-100 Stearate,Dimethicone,Polyglyceryl-6 Distearate,Polyglyceryl-10 Stearate,Cladosiphon Okamuranus Extract,Glyceryl Stearate,Polyacrylamide,Porphyra Yezoensis Extract,Simmondsia Chinensis (Jojoba) Seed Oil,Helianthus Annuus (Sunflower) Seed Oil,Sodium Hyaluronate,Tocopherol,Niacinamide,Paeonol,Portulaca Oleracea Extract,Laureth-7,Ethylhexylglycerin,Caprylhydroxamic Acid,1,2-Hexanediol,Disodium EDTA,Glycine

🎯 Purpose 18 words ▾

Temporarily protects and helps relieve minor skin irritation and itching due to eczema, rashes, and extremely dry skin.

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