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Eczema Cream 1 g/100mL Cream, 100 mL — NDC 85303-0001-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Eczema Cream 1 g/100mL Cream, 100 mL — NDC 85303-001-01 (Billing 85303-0001-01)

by Kyte Baby LLC · 100 mL in 1 BOTTLE, PUMP

This is a package of 100 mL of Eczema Cream 1 g/100mL Cream from Kyte Baby LLC, marketed since Jul 2025 and currently FDA-listed. It is this product's only package size.

NDC 85303-0001-01
🏷️ FDA NDC (as labeled) 85303-001-01 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85303-001-01
Product NDC 85303-001
11-digit billing NDC 85303000101
RxCUI 240651
UNII 8PI54V663Y
Application # M016
SPL Set ID 30c943aa-d9dc-5c16-e063-6294a90a3c58
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 2025-07-01
Route TOPICAL
Dosage form CREAM
Substance OATMEAL
Quick answers
  • RxCUI (RxNorm): 240651
Why two NDCs? The FDA registers this code as 85303-001-01 — 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 → 85303-0001-01. 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.

Clinical

🧪 What is this product?

This is an over-the-counter topical cream containing oatmeal, marketed under FDA's OTC monograph rules for eczema products. Oatmeal is commonly used in skin-care products as a moisturizing and soothing ingredient for dry, irritated, or itchy skin. The cream is applied directly to affected skin areas. This product type is regulated as an OTC monograph drug, meaning it follows an established category standard rather than undergoing individual FDA review.

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.

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
85303-0001-01 You're viewing this Main listing 100 mL in 1 BOTTLE, PUMP 2025-10-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Baby Eczema Therapy 10 mg/g 00363-0986-28 Walgreen 141 g — — Discontinued —
Walgreens Eczema Relief Body Skin Protectant 10 mg/g 00363-8395-01 Walgreen 226 g — — FDA listed —
Eucerin Eczema Relief Body 1 g/100g 10356-0365-02 Beiersdorf 7 g — — FDA listed —
Eucerin Eczema Relief Flare Up Treatment 1 g/100g 10356-0371-07 Beiersdorf 57 g — — FDA listed —
Eczema Soothing Moisturizing Cream 10 mg/g 11344-0965-98 Nice-Pak 207 g — — FDA listed —
SOOTHE Moisturizing Rescue Cream .01 g/mL 14222-2430-01 Rodan 1 tube — — FDA listed —
Colloidal oatmeal 10 mg/g 37808-0128-28 H 141 g — — FDA listed —
CeraVe Developed With Dermatologist Baby Eczema Relief Cream 10 mg/mL 49967-0536-01 L'Oreal 148 ml — — FDA listed —
KIEHLS SINCE 1851 Ultra Facial Meltdown Recovery 10 mg/mL 49967-0571-01 LOreal 1 tube — — FDA listed —
La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing Relief 10 mg/mL 49967-0621-01 L'Oreal 1 tube — — Discontinued —
CeraVe Developed with Dermatologists Eczema Relief Creamy 10 mg/mL 49967-0951-01 L'Oreal 236 ml — — FDA listed —
Derma-e Eczema Relief .01 g/g 51326-0870-04 Topiderm, 1 jar — — FDA listed —
Eczema 10 mg/mL 52915-0120-02 ORGANIC 57 ml — — FDA listed —
Renew Intensive Skin Therapy Targeted Eczema Treatment .5 g/50mL 54473-0410-01 Melaleuca 50 ml — — FDA listed —
Eczema Hand Relief 1 g/100g 61328-0010-00 Skinfix, 90 g — — FDA listed —
Skinfix Hand Repair 1 g/100mL 61328-0106-11 Skinfix, 30 ml — — FDA listed —
Skin Soothing Cream - Nut Free 1 mg/g 62742-4194-01 Allure 113.5 g — — FDA listed —
Baby Eczema Therapy 10 mg/g 64024-0601-34 Aldi, 227 g — — FDA listed —
Avene XERACALM Eczema Calming Relief Balm 1 g/100g 64760-0777-01 Pierre 100 g — — FDA listed —
Honest Eczema Cream 1 g/100g 69366-0504-19 The 200 g — — FDA listed —
Olay Ultimate Sensitive Colloidal Oatmeal Skin Protectant Moisturizer Fragrance Free 1 g/100g 69423-0743-48 The 1 jar — — FDA listed —
La Roche Posay Laboratoire Dermatologique Lipikar Eczema Relief 10 mg/mL 69625-0620-02 COSMETIQUE 200 ml — — FDA listed —
CVS Eczema Relief Skin Protectant 10 mg/g 69842-0388-01 CVS 226 g — — FDA listed —
Aveeno Baby Eczema Therapy Moisturizing 10 mg/g 69968-0404-01 Kenvue 14 g — — FDA listed —
Aveeno Eczema Therapy Itch Relief Balm 10 mg/g 69968-0419-01 Kenvue 312 g — — FDA listed —
Aveeno Eczema Therapy daily moisturizing 10 mg/g 69968-0421-01 Kenvue 14 g — — FDA listed —
Aveeno Baby Eczema Therapy Nighttime Balm 10 mg/g 69968-0540-01 Kenvue 312 g — — FDA listed —
Aveeno Calm Plus Restore Skin Therapy Balm 10 mg/g 69968-0755-02 Kenvue 1 tube — — FDA listed —
Aveeno Eczema Therapy Nighttime Itch Relief Balm 10 mg/g 69968-0772-01 Kenvue 312 g — — FDA listed —
Aveeno Eczema Therapy Daily Moisturizing 10 mg/mL 69968-0774-02 Kenvue 354 ml — — FDA listed —
Aveeno Baby Eczema Therapy Moisturizing 10 mg/g 69968-0901-02 Kenvue 341 g — — FDA listed —
Aveeno Baby Eczema Therapy Moisturizing Cream Clubtray 69968-0921-09 Kenvue 1 kit — — FDA listed —
Aveeno Baby Eczema Therapy Moisturizing 10 mg/mL 69968-0923-02 Kenvue 354 ml — — FDA listed —
Eczema Relief Cream 1 g/100g 71521-0025-15 Lavior 15 g — — FDA listed —
DERMA SANTE Anti Eczema Cream 10 mg/mL 71970-0324-00 Hope 1 tube — — FDA listed —
Evereden Healing Eczema Treatment 1 g/100mL 72113-0106-03 Eden 1 tube — — FDA listed —
Mountain Ice Eczema 10 mg/g 72793-0400-01 Mountainside 118 g — — FDA listed —
LMNOOP Eczema Relief Cream 1 g/100g 73076-0128-01 Shenzhen 50 g — — FDA listed —
LMNOOP Baby Eczema Relief Cream 1 g/100g 73076-0141-02 Shenzhen 100 g — — FDA listed —
LMNOOP Urticaria Cream 1 g/100g 73076-0142-02 Shenzhen 100 g — — FDA listed —
iShancare Anti-itch Cream 1 g/100g 73076-0145-01 Shenzhen 10 g — — FDA listed —
LMNOOP Antifungal Cream 1 g/100g 73076-0147-01 Shenzhen 50 g — — FDA listed —
LMNOOP Itch Relief Cream 1 g/100g 73076-0148-01 Shenzhen 50 g — — FDA listed —
iShancare Baby Eczema Cream 1 g/100g 73076-0152-02 Shenzhen 100 g — — FDA listed —
iShancare Seborrheic Dermatitis Cream 1 g/100g 73076-0153-01 Shenzhen 50 g — — FDA listed —
LMNOOP Tinea Treatment 1 g/100g 73076-0200-01 Shenzhen 50 g — — FDA listed —
LMNOOP Athletes Foot Cream 1 g/100g 73076-0201-01 Shenzhen 50 g — — FDA listed —
LMNOOP Seborrheic Dermatitis Treatment 1 g/100g 73076-0203-01 Shenzhen 50 g — — FDA listed —
LMNOOP Feminine Cream 1 g/100g 73076-0205-01 Shenzhen 50 g — — FDA listed —
LMNOOP Vaginal Antifungal Cream 1 g/100g 73076-0208-01 Shenzhen 1 applicator — — FDA listed —
LMNOOP Eczema Relief Cream 1 g/100g 73076-0209-03 Shenzhen 100 g — — FDA listed —
Yimimde Tinea Corporis Cream 1 g/100g 73076-0307-03 Shenzhen 100 g — — FDA listed —
Yimimde Masculine Care Cream 1 g/100g 73076-0308-02 Shenzhen 56 g — — FDA listed —
HOMWIS Urticaria Relief Cream 1 g/100g 73076-0506-02 Shenzhen 50 g — — FDA listed —
Colloidal oatmeal 10 mg/g 79481-6601-01 Meijer, 141 g — — FDA listed —
Colloidal oatmeal 10 mg/g 79481-9965-01 Meijer, 207 g — — FDA listed —
Skin Mercy Intense Recovery Cream 1 g/100mL 80921-0001-50 Cultskin 1 tube — — FDA listed —
Skin Mercy Recovery Cream 1 g/100mL 80921-0002-50 Cultskin 1 tube — — FDA listed —
Barrier Build Skin Protectant Cream 1 g/100mL 81110-0800-02 ILIA, 1 jar — — FDA listed —
M3 NATURALS Eczema Cream 10 mg/mL 81985-0186-01 M3 118 ml — — FDA listed —
CeraVe Developed with Dermatologists Eczema Relief Moisturizing 10 mg/mL 82046-0040-01 L'Oreal 236 ml — — FDA listed —
THERAPLEX Eczema Therapy 10 mg/g 82280-0425-00 THERAPLEX, 170.1 g — — FDA listed —
THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal Oatmeal 10 mg/g 82280-0618-00 THERAPLEX, 85.05 g — — FDA listed —
THERAPLEX Eczema Therapy 10 mg/g 82280-0816-00 THERAPLEX, 170.1 g — — FDA listed —
Prequel Barrier Cream 1 g/100g 82800-0009-01 The 296 g — — Discontinued —
DERMOIA Manuka Honey Eczema Cream 10 mg/mL 83524-0407-00 TREASUREWISE 120 ml — — FDA listed —
Puriya Eczema Cream 1 g/100g 84711-0002-04 IPC 113 g — — FDA listed —
Serawise Eczema Rescue 10 mg/mL 85050-0575-00 DrAnaMaria.com 1 jar — — FDA listed —
Soteri Skin Long-Term Eczema Relief Cream 1 g/100mL 85265-0103-01 Soteri 1 bottle — — FDA listed —
Eczema Cream 1 g/100mLthis 85303-0001-01 Kyte 100 ml — — FDA listed —
Tagrid Eczema Cream Colloidal Oatmeal 1% 1 g/100g 85384-0024-01 TAGRID 56.7 g — — FDA listed —
RoyceDerm Eczema Relief Cream 1.13 g/113g 85424-0010-01 RoyceDerm 113 g — — FDA listed —
Eczema Therapy .96 g/96g 85951-0010-01 SilverCeuticals 1 g — — FDA listed —
Radlive Active Defense Nano-Silver Cream .96 g/96g 85951-0200-34 SilverCeuticals 1 g — — FDA listed —
Neurexa 10 mg/mL 87110-0004-01 METHODIQ 1 tube — — FDA listed —
Baby Eczema Moisturizing Cream 1 g/100g 87781-0003-01 Foshan 80 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
Jul 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.

What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 C269C4G2ZQ
    Sodium alginate is a natural thickener and gelling agent derived from seaweed. In medicines, it acts as a binder to hold ingredients together, a thickener to adjust texture, and a disintegrant to help the tablet or capsule break apart for absorption.
  • UNII 1QR1QRA9BU
    A fatty alcohol derived from peanut oil or made synthetically. It serves as an emollient and thickener in creams and ointments, helping create smooth texture and improve product consistency.
  • UNII 6JVW35JOOJ
    Arachidyl glucoside is a plant-derived emulsifier and skin-conditioning agent made from arachidyl alcohol and glucose. It helps mix oil and water-based ingredients together in formulations and improves product texture and spreadability.
  • UNII 9G1OE216XY
    Docosanol is a waxy, fatty alcohol derived from plant sources. It acts as an emollient and thickener in topical medicines, helping to soften the skin and improve product texture and stability.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • 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 C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • 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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 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 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 G1L3HT4CMH
    A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII IV0Z586Z4Y
    A synthetic oil derived from isostearic acid, used as an emollient and lubricant in topical formulations to soften the skin and improve the texture and spreadability of creams, lotions, and ointments.
  • UNII XX66GGY95E
    A synthetic glycerin-based compound used as a humectant and preservative booster in medicines. It helps retain moisture in the formulation and may enhance the preservative system's effectiveness.
  • UNII YP8C822TNZ
    A type of microalgae used as a natural colorant and nutritional ingredient. It provides green or yellow pigmentation to medicines and may contribute beneficial compounds to the formulation.
  • 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 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII IYR6K8KQ5K
    A plant extract from sophora flavescens root used as a natural colorant and flavoring agent in medicines. It may also help preserve the product and provide texture.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • UNII 5EHL50I4MY
    A sodium salt compound used as a chelating agent in medicines. It binds to metals and minerals to improve stability, prevent discoloration, and help the medication stay effective longer.
  • 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 U3176B0S5J
    Vincetoxicum atratum is a plant extract used as a natural ingredient in some formulations. It may serve roles such as a flavoring agent, colorant, or botanical additive to support the overall product composition.
  • 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.

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

The official label also statesInactive Ingredients Water (Aqua), Glycerin, Butyrospermum Parkii (Shea Butter, Cetearyl Alcohol, Isostearyl Isostearate, Propanediol, Stearyl Alcohol. Caprylic/Capric Triglyceride, Arachidyl Alcohol, Simmondsia Chinensis (Jojoba) Seed Oil, Butylene Glycol, Arachidyl Glucoside, Cynanchum Atratum Extract, Methylheptyglycerin, Sophora Angustifolia Root Extract, Hydroxyacetophenone, Tocopherol, Algin, Caprylhydroxamic Acid, Tetrasodium Glutamate Diacetate, Behenyl Alcohol, Xanthan Gum, Caprylyl Glycol, Nannochloropsis Oculata (Algae) Extract, Citric Acid, Sodium Hydroxide, Hydrogenated Lecithin, 1,2-Hexanediol, Sclerotium Gum, Arnica Montana Flower 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.

Manufacturer & labeler

LabelerKyte Baby LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code85303
First marketedJul 2025
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.

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 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 17 words ▾

Uses Temporarily protects and helps relieve minor skin irritation and itching due to: • eczema • rashes

⏱️ Dosage and Administration 15 words ▾

Directions • Apply liberally to dry or imitated skin as needed. Safe for daily use.

⚠️ Warnings 60 words ▾

Warnings 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 the reach of children. If swallowed, get medical advice or contact a Poison Control Center right away.

🧪 Active Ingredient 2 words ▾

Drug Facts

🧪 Inactive Ingredients 68 words ▾

Inactive Ingredients Water (Aqua), Glycerin, Butyrospermum Parkii (Shea Butter, Cetearyl Alcohol, Isostearyl Isostearate, Propanediol, Stearyl Alcohol. Caprylic/Capric Triglyceride, Arachidyl Alcohol, Simmondsia Chinensis (Jojoba) Seed Oil, Butylene Glycol, Arachidyl Glucoside, Cynanchum Atratum Extract, Methylheptyglycerin, Sophora Angustifolia Root Extract, Hydroxyacetophenone, Tocopherol, Algin, Caprylhydroxamic Acid, Tetrasodium Glutamate Diacetate, Behenyl Alcohol, Xanthan Gum, Caprylyl Glycol, Nannochloropsis Oculata (Algae) Extract, Citric Acid, Sodium Hydroxide, Hydrogenated Lecithin, 1,2-Hexanediol, Sclerotium Gum, Arnica Montana Flower Extract

🎯 Purpose 8 words ▾

ACTIVE INGREDIENT COLLOIDAL OATMEAL 1% PURPOSE SKIN PROTECTANT

📄 Keep Out of Reach of Children 20 words ▾

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

📄 Package Label / Principal Display Panel 4 words ▾

Kyte Skin Eczema Cream

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 Eczema Cream — the ingredient across all brands.

Top reported reactions

Anxiety1
Conjunctivitis1
Depression1
Eczema1
Headache1
Malaise1
Migraine1

Reporter sex

4 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.

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 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 Kyte Baby LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Kyte Baby 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.
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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.