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Serawise Eczema Rescue OATMEAL 10 mg/mL Cream, 1 jar

by DrAnaMaria.com LLC · 1 JAR in 1 BOX (85050-575-00) / 118.29 mL in 1 JAR
NDC 85050-0575-00
🏷️ FDA NDC (as labeled) 85050-575-00 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) 85050-575-00
Product NDC 85050-575
11-digit billing NDC 85050057500
RxCUI 240651
UNII 8PI54V663Y
Application # M016
SPL Set ID e805866a-2349-4b86-bc83-a7c859cb9403
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 2024-12-02
Route TOPICAL
Dosage form CREAM
Substance OATMEAL
Why two NDCs? The FDA registers this code as 85050-575-00 — 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 → 85050-0575-00. 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

LabelerDrAnaMaria.com LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code85050
First marketedDec 2024
Product typeHuman Otc Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

Serawise Eczema Rescue is an over-the-counter topical cream containing oatmeal as its active ingredient. This product is marketed under FDA's OTC monograph rules for its category. Oatmeal is commonly used in skincare products applied to the skin to help soothe and moisturize irritated or dry areas. This cream is intended for topical application to affected skin.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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
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/mLthis 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

🏛️
2024
On the market since
Dec 2024
📍
2026
Currently FDA-listed
2 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 Serawise Eczema Rescue (this brand).

Top reported reactions

Rash4
Weight Decreased3
Abdominal Pain2
Anaemia2
Anal Incontinence2
Diarrhoea2
Abdominal Discomfort1

Age at onset

Adult1

Reporter sex

17 reports
Male · 27%
Female · 73%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 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
85050-0575-00 You're viewing this 1 JAR in 1 BOX (85050-575-00) / 118.29 mL in 1 JAR 2024-12-02 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 85050-575-00, 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: 85050-0575-00, written without dashes as 85050057500. 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 85050-0575-00, the first segment (85050) is the labeler code FDA assigned to DrAnaMaria.com LLC; the middle segment (0575) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 DrAnaMaria.com LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
DrAnaMaria.com 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.

📄 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 duee to: rashes eczema poison ivy, oak, or sumac insect bites

⏱️ Dosage and Administration 4 words ▾

Directions Apply as Needed

⚠️ Warnings 68 words ▾

Warnings For external use only When using this product do not get into eyes. Stop use and consult a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away. If pregnant or breast-feeding, ask a health professional before use.

🧪 Active Ingredient 8 words ▾

Active ingredient Colloidal oatmeal 1% Purpose Skin protectant

🧪 Inactive Ingredients 33 words ▾

Inactive Ingredients Beeswax, Butyrospermum Parkii (Shea) Butter, Calcium Gluconate, Ceteareth-20, Cetearyl Alcohol, Cyanocobalamin (VitB12), Dimethicone, Gluconolactone, Glycerin, Glyceryl Stearate, Hypericum Perforatum Leaf Extract, Peg-100 Stearate, Persea Gratissima (Avocado) Oil, Sodium Benzoate, Water (Aqua).

🎯 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 ↗
← 85050-0012-00 · DrAnaMaria. 85052-0101-04 · Vera →
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.