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ECZEMA OATMEAL 10 mg/mL Cream, 57 mL — NDC 52915-0120-02 package photo

ECZEMA OATMEAL 10 mg/mL Cream, 57 mL

by ORGANIC & SUSTAINABLE BEAUTY · 57 mL in 1 JAR (52915-120-02)
NDC 52915-0120-02
🏷️ FDA NDC (as labeled) 52915-120-02 billing pads the product segment with a zero
This package
Contains57 mL Pack sizes3 compare ↓
Also comes in: 14 ml 52915-0120-05 133 ml 52915-0120-45
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) 52915-120-02
Product NDC 52915-120
11-digit billing NDC 52915012002
RxCUI 240651
UNII 8PI54V663Y
Application # M016
SPL Set ID 926706b5-0a08-4604-b5ad-3b3ddfd7f02d
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 2012-12-01
Route TOPICAL
Dosage form CREAM
Substance OATMEAL
Why two NDCs? The FDA registers this code as 52915-120-02 — 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 → 52915-0120-02. 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

LabelerORGANIC & SUSTAINABLE BEAUTY
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code52915
First marketedDec 2012
Product typeHuman Otc Drug
Portfolio14 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

This is a topical cream containing oatmeal, marketed as an over-the-counter monograph product for eczema relief. Oatmeal is commonly used in skincare products for its soothing and moisturizing properties, and is typically applied to the skin to help calm irritation and dryness. This product is not individually reviewed by the FDA; instead it is manufactured under the FDA's established guidelines for non-prescription monograph drugs in this category.

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 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 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 P0M7O4Y7YD
    A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
  • UNII 331KBJ17RK
    Canola oil is a plant-based oil derived from rapeseed. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients, and may improve how the body absorbs certain medications.
  • 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 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 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 87L0D4U3M0
    A plant oil derived from clary sage flowers. It's used as a fragrance and flavoring agent in medicines to improve taste and aroma.
  • UNII 7IGF0S7R8I
    Phytic acid is a naturally occurring compound found in plants that acts as a chelating agent and preservative in medicines. It helps stabilize formulations and prevent oxidation of active ingredients.
  • UNII TM2TZD4G4A
    A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
  • UNII ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • 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 IJ67X351P9
    A natural plant extract from rosemary leaves used as a preservative to help prevent oils and fats in the medicine from spoiling or becoming rancid during storage.
  • 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 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 9Q24RAI43V
    A plant extract from wild pansy flowers used as a natural coloring and flavoring agent in medicines. It may add color and taste while serving as a botanical ingredient in the formulation.
  • 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 E2H9ET15AT
    Yucca schidigera root is a plant extract used as a natural flavor masker and foaming agent. It helps reduce bitter tastes and improve how the medicine mixes or disperses in liquids.

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

The official label also statesWater, calendula officinalis flower extract, caprylic/capric triglyceride, cetyl alcohol, stearic acid, cetearyl olivate, sorbitan olivate, canola oil, allantoin, viola tricolor extract, yucca schidigera root extract, aloe barbadensis leaf juice, rosmarinus officinalis leaf extract, lavandula angustifolia (lavender) oil, salvia sclarea (clary) oil, phytic acid, caprylhydroxamic acid, glyceryl caprylate.

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.
Try another pack size: 14 ml 133 ml
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
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/mLthis 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/100mL 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 —
Derma E Eczema Relief 10 mg/mL 54108-8712-01 derma 175 ml — — FDA listed —
BIA Eczema Relief 10 mg/mL 83196-0582-10 Codex 1 tube — — FDA listed —
Dermoia Eczema Relief Colloidal Oatmeal 10 mg/mL 83524-0944-00 Treasurewise 355 ml — — FDA listed —
Eczema 10 mg/mL 52915-0010-05 ORGANIC 14 ml — — FDA listed —
Serawise Eczema Relief 10 mg/mL 85050-0012-00 DrAnaMaria. 1 jar — — 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

🏛️
2012
On the market since
Dec 2012
📍
2026
Currently FDA-listed
14 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.

🔬 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 OATMEAL — the ingredient across all brands.

Top reported reactions

Rash47
Pruritus46
Pain18
Fatigue17
Arthralgia16
Dizziness15
Nausea15

Age at onset

Neonate1
Infant2
Child3
Adolescent1
Adult23
Elderly38

Reporter sex

0 reports

Serious outcomes

Hospitalization113
Life-threatening12
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 38 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
52915-0120-02 You're viewing this 57 mL in 1 JAR (52915-120-02) 2012-12-01 Active
52915-0120-05 14 mL in 1 TUBE (52915-120-05) 2012-12-01 Active
52915-0120-45 133 mL in 1 CONTAINER (52915-120-45) 2012-12-01 Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 52915-0120-02?
NDC 52915-0120-02 contains 57 mL — 57 ml in 1 jar.
What is the difference between NDC 52915-0120-02 and NDC 52915-0120-05?
Both are ECZEMA OATMEAL 10 mg/mL Cream — the drug itself is identical. NDC 52915-0120-02 is the 57 mL package, while NDC 52915-0120-05 is the 14 ml package.
What NDC number is used to bill for this package of ECZEMA OATMEAL 10 mg/mL Cream?
Bill NDC 52915-0120-02 — the 11-digit billing format is 52915012002. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 52915-120-02, 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: 52915-0120-02, written without dashes as 52915012002. 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 52915-0120-02, the first segment (52915) is the labeler code FDA assigned to ORGANIC & SUSTAINABLE BEAUTY; the middle segment (0120) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 ORGANIC & SUSTAINABLE BEAUTY. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 14 ml (52915-0120-05), 133 ml (52915-0120-45). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
ORGANIC & SUSTAINABLE BEAUTY 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 & helps relieve minor skin irritation and itching due to: Rashes Eczema Poison ivy, oak, or sumac Insect bites

⏱️ Dosage and Administration 25 words ▾

Directions Apply liberally onto desired area Reapply as needed. Children under 6 months: ask a doctor. Use in combination with our Eczema Shampoo & Bodywash.

⚠️ Warnings 58 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 reach of children. If swallowed, get medical help or contact Poison Control within the U.S. (1-800-222-1222)

🧪 Active Ingredient 5 words ▾

Active ingredient Colloidal Oatmeal 1%

🧪 Inactive Ingredients 49 words ▾

Inactive ingredients Water, calendula officinalis flower extract, caprylic/capric triglyceride, cetyl alcohol, stearic acid, cetearyl olivate, sorbitan olivate, canola oil, allantoin, viola tricolor extract, yucca schidigera root extract, aloe barbadensis leaf juice, rosmarinus officinalis leaf extract, lavandula angustifolia (lavender) oil, salvia sclarea (clary) oil, phytic acid, caprylhydroxamic acid, glyceryl caprylate.

🎯 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 ↗
← 52915-0076-19 · ORGANIC 52915-0140-05 · ORGANIC →
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.