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Serawise Eczema Relief OATMEAL 10 mg/mL Cream, 1 jar — NDC 85050-0012-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Serawise Eczema Relief OATMEAL 10 mg/mL Cream, 1 jar — NDC 85050-012-00 (Billing 85050-0012-00)

by DrAnaMaria. Com LLC · 1 JAR in 1 BOX / 118.29 mL in 1 JAR

This is a package of 1 jar of Serawise Eczema Relief OATMEAL 10 mg/mL Cream from DrAnaMaria. Com LLC, marketed since Aug 2026 and currently FDA-listed. It is this product's only package size.

NDC 85050-0012-00
🏷️ FDA NDC (as labeled) 85050-012-00 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Sep 10, 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

NDC database record

One package, one record: these facts belong to NDC 85050-012-00 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
85050 labeler · 012 product · 00 package
Package marketed since
Aug 14, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0850063442039
FDA record last changed
Sep 10, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85050-012-00
Product NDC 85050-012
11-digit billing NDC 85050001200
RxCUI 240651
UNII 8PI54V663Y
UPC 0850063442039
Application # M016
SPL Set ID f0681436-d140-4e02-afe4-5b16de07afcd
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 2026-08-14
Route TOPICAL
Dosage form CREAM
Substance OATMEAL
Quick answers
  • RxCUI (RxNorm): 240651
Why two NDCs? The FDA registers this code as 85050-012-00 — 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 → 85050-0012-00. 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.

Clinical

🧪 What is this product?

Serawise Eczema Relief Oatmeal is a topical cream containing oatmeal as its active ingredient. This product is marketed as an over-the-counter monograph drug, meaning it follows established FDA guidelines for this category rather than undergoing individual review. Oatmeal is commonly used in skincare products applied to the skin to help soothe and moisturize irritated areas. The cream form allows the ingredient to be spread over 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.

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
85050-0012-00 You're viewing this Main listing 1 JAR in 1 BOX / 118.29 mL in 1 JAR 2026-08-14 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
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 —
La Roche Posay Laboratoire Dermatologique Lipikar Eczema Relief 10 mg/mL 69625-0620-02 COSMETIQUE 200 ml — — FDA listed —
DERMA SANTE Anti Eczema Cream 10 mg/mL 71970-0324-00 Hope 1 tube — — FDA listed —
M3 NATURALS Eczema Cream 10 mg/mL 81985-0186-01 M3 118 ml — — FDA listed —
DERMOIA Manuka Honey Eczema Cream 10 mg/mL 83524-0407-00 TREASUREWISE 120 ml — — FDA listed —
Eczema 10 mg/mL 52915-0120-02 ORGANIC 57 ml — — 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 —
Serawise Eczema Rescue 10 mg/mL 85050-0575-00 DrAnaMaria.com 1 jar — — FDA listed —
Aveeno Baby Eczema Therapy Moisturizing 10 mg/mL 69968-0923-02 Kenvue 354 ml — — FDA listed —
Dermoia Eczema Relief Colloidal Oatmeal 10 mg/mL 83524-0944-00 Treasurewise 355 ml — — FDA listed —
CeraVe Developed With Dermatologist Baby Eczema Relief Cream 10 mg/mL 49967-0536-01 L'Oreal 148 ml — — FDA listed —
Eczema 10 mg/mL 52915-0010-05 ORGANIC 14 ml — — FDA listed —
Serawise Eczema Relief 10 mg/mLthis 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

🏛️
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.

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 6VNO72PFC1
    A natural oil extracted from avocado fruit. It's used in medicines as an emollient and carrier to help dissolve or deliver active ingredients and improve how the product feels on skin or mucous membranes.
  • UNII 2ZA36H0S2V
    Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.
  • UNII SQE6VB453K
    A calcium salt derived from gluconic acid. It acts as a buffer and mineral supplement in formulations, helping maintain stable pH and adding nutritional calcium content to the product.
  • UNII YRC528SWUY
    A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
  • UNII 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 P6YC3EG204
    Cyanocobalamin is a synthetic form of vitamin B12. It's used in medicines as a nutritional ingredient and to help maintain the product's stability and potency over time.
  • 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 WQ29KQ9POT
    Gluconolactone is a mild organic acid derived from glucose. It functions as a buffer and pH regulator in medicines, helping maintain stable acidity levels and improve product stability.
  • 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 DOC7OB843Y
    Hypericum perforatum leaf is a plant extract used in some formulations as a flavoring agent or natural ingredient. It may contribute subtle taste or aroma characteristics to the medicine.
  • 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 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 OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • 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.

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

The official label also statesBeeswax, Butyrospermum Parkii (Shea) Butter, Calcium Gluconate, Ceteareth-20, Cetearyl Alcohol, Cyanocobalamin (Vit B12), Dimethicone, Gluconolactone, Glycerin, Glyceryl Stearate, Hypericum Perforatum (St. John's Wort) Leaf Extract, Peg-100 Stearate, Persea Gratissima (Avocado) Oil, Sodium Benzoate, Water (Aqua).

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

LabelerDrAnaMaria. Com LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code85050
First marketedAug 2026
Product typeHuman Otc Drug

More NDCs from DrAnaMaria. Com LLC labeler code 85050

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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 26 words ▾

Uses temporarily protects and helps relieve minor skin irritation and itching due to: ▪ rashes ▪ eczema ▪ poison ivy, oak, or sumac ▪ insect bites

⏱️ Dosage and Administration 4 words ▾

Directions Apply As Needed

⚠️ Warnings 70 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 37 words ▾

Inactive Ingredients Beeswax, Butyrospermum Parkii (Shea) Butter, Calcium Gluconate, Ceteareth-20, Cetearyl Alcohol, Cyanocobalamin (Vit B12), Dimethicone, Gluconolactone, Glycerin, Glyceryl Stearate, Hypericum Perforatum (St. John's Wort) Leaf Extract, Peg-100 Stearate, Persea Gratissima (Avocado) Oil, Sodium Benzoate, Water (Aqua).

🎯 Purpose 3 words ▾

Purpose Skin protectant

📄 When Using This Product 9 words ▾

When using this product do not get into eyes.

📄 Stop Use and Ask a Doctor If 27 words ▾

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

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

📄 Package Label / Principal Display Panel 6 words ▾

Package Labeling: Outer Package Inner Package

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

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 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.
← 85046-0574-00 · Saltyface 85050-0575-00 · DrAnaMaria.com →
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.