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Sarna Colloidal Oatmeal 20 mg/mL Lotion, 5 mL — NDC 00316-0256-17 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sarna Colloidal Oatmeal 20 mg/mL Lotion, 5 mL — NDC 0316-0256-17 (Billing 00316-0256-17)

by Crown Laboratories, Inc. · 5 mL in 1 TUBE

This is a package of 5 mL of Sarna Colloidal Oatmeal 20 mg/mL Lotion from Crown Laboratories, Inc., marketed since Jan 2025 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00316-0256-17
🏷️ FDA NDC (as labeled) 0316-0256-17 billing pads the labeler segment with a zero
This package
Contains5 mL Pack sizes2 compare ↓
Main listing for product 0316-0256 · Also comes in: 222 ml 0316-0256-75
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

NDC database record

One package, one record: these facts belong to NDC 0316-0256-17 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0316 labeler · 0256 product · 17 package
Package marketed since
Nov 11, 2025
Sample package
Yes — professional sample, not for sale
Listing certified through
Dec 31, 2027
Barcode (UPC)
0303160256752
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0316-0256-17
Product NDC 0316-0256
11-digit billing NDC 00316025617
RxCUI 1591951
UNII 8PI54V663Y
UPC 0303160256752
Application # M016
SPL Set ID 2d6b1872-9f4d-9eb3-e063-6394a90ab675
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 2025-01-12
Route TOPICAL
Dosage form LOTION
Substance OATMEAL

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 042865
GCN 92534
HICL code 002224
Ingredient (HICL) Colloidal Oatmeal
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L2
Therapeutic class — intermediate (HIC2) Emollients
HIC3 code L2A
Therapeutic class — specific (HIC3) Emollients
AHFS code 84:24.04.00
AHFS class Basic Lotions And Liniments
FDB label name SARNA ECZEMA RELIEF 2% LOTION
FDB brand name Sarna Eczema Relief
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 042865
  • GCN: 92534
  • HICL (First Databank): 002224
  • AHFS class code: 84:24.04.00
  • RxCUI (RxNorm): 1591951
Why two NDCs? The FDA registers this code as 0316-0256-17 — a 4-4-2 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 labeler segment → 00316-0256-17. 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

Label name SARNA ECZEMA RELIEF 2% LOTION Ingredient Colloidal Oatmeal
🧪 What is this product?

Sarna Colloidal Oatmeal is a topical lotion containing oatmeal as its active ingredient. It is an over-the-counter product marketed under FDA's monograph rules for its category. Colloidal oatmeal is commonly used in skin-care products and is typically applied to the skin to help soothe and moisturize irritated or dry areas.

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.
Try another pack size: 222 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00316-0256-17 You're viewing this Main listing 5 mL in 1 TUBE 2025-11-11 — Active
00316-0256-75 0316-0256-75 222 mL in 1 TUBE 2025-01-12 — Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 5 mL — 5 ml in 1 tube.
How does this package differ from NDC 00316-0256-75?
Both are Sarna Colloidal Oatmeal 20 mg/mL Lotion — the drug itself is identical. This page's package is the 5 mL one, while NDC 00316-0256-75 is the 222 ml package.
What NDC number is used to bill for this package of Sarna Colloidal Oatmeal 20 mg/mL Lotion?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sarna 20 mg/mLthis 00316-0256-17 Crown 5 ml — — FDA listed —
Everyday Eczema 2 g/100g 54136-0181-25 Better 244 g — — FDA listed —
Calming Itch and Irritation 2 g/100g 54136-0183-24 Better 239 g — — FDA listed —
MG217 Eczema Face .02 g/g 68093-7245-01 Wisconsin 170 g — — FDA listed —
The Indigo Calming 20 mg/mL 69417-0140-03 TATCHA 1 jar — — Discontinued —
Aveeno Eczema Therapy Rescue Relief Treatment 20 mg/mL 69968-0802-01 Kenvue 14 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Jan 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.

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 TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII RZX9PV23DY
    A synthetic peptide (short chain of amino acids) used as a conditioning or skin-feel agent in topical formulations. It helps improve texture and may enhance product consistency or absorption properties.
  • 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 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 A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • 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 59TL3WG5CO
    A synthetic polymer made by crosslinking acrylic acid with allyl sucrose. It thickens liquids, forms gels, and helps control how fast the medicine is released in your body.
  • 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 4Q43814HXS
    Cetyl acetate is a waxy compound made by combining cetyl alcohol with acetic acid. It works as a binder and thickener in medicines, helping to hold ingredients together and give the product a smooth, creamy texture.
  • 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 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 6YSS42VSEV
    Fructose is a natural sugar derived from fruits and plants. It's used in medicines as a sweetener and filler to improve taste and add bulk to tablets or syrups.
  • UNII 5SL0G7R0OK
    A simple sugar made from corn or other plants, used in medicines as a filler and sweetener. It helps create the right texture and taste in tablets, powders, and liquid formulations.
  • 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 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 XJ6S9RV06F
    Maltose is a simple sugar made from grain starches. It works as a sweetener and filler in medicines to improve taste and add bulk to tablets and powders.
  • UNII 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII 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 TU7HW0W0QT
    A salt derived from lactic acid, sodium lactate acts as a buffer and pH stabilizer in medicines. It helps maintain the product's acidity level and can also serve as a humectant to retain moisture.
  • UNII 469OTG57A2
    Sodium pyrrolidone carboxylate is a synthetic polymer derived from pyrrolidone chemistry. It functions as a solubilizer and binder in medications, helping dissolve poorly water-soluble drugs and hold tablet ingredients together.
  • UNII B8WCK70T7I
    Trehalose is a natural sugar made from two glucose molecules linked together. It's used in medicines as a filler to add bulk, a sweetener for taste, and a stabilizer to help keep active ingredients effective during storage.
  • UNII 69534Y66NO
    A synthetic compound made from fatty alcohol derivatives. It works as an emulsifier and surfactant to help blend oil and water-based ingredients together in the medicine formulation.
  • UNII 8W8T17847W
    A nitrogen-containing chemical compound used in pharmaceuticals as a humectant to retain moisture, and sometimes as a keratolytic agent in topical formulations to help soften and remove dead skin cells.
  • 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 44FQ49X6UN
    A polysaccharide (complex carbohydrate) derived from yeast cell walls. In medicines, it acts as a binder to hold tablet ingredients together and may help with tablet structure and stability.

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

The official label also states1,2-Hexanediol, Acetyl Heptapeptide-4, Allantoin, Bacillus Ferment, Beta-Glucan, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Acetate, Citric Acid, Dimethicone, Fructose, Glucose, Glycerin, Glyceryl Stearate, Hydroxyacetophenone, Maltose, Pentylene Glycol, Simmondsia Chinesis (Jojoba) Seed Oil, Sodium Chloride, Sodium Hyaluronate, Sodium Hydroxide, Sodium Lactate, Sodium PCA, Trehalose, Triceteareth-4 Phosphate, Urea, Water

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

LabelerCrown Laboratories, Inc.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code00316
First marketedJan 2025
Product typeHuman Otc Drug
Portfolio6 products on file

More NDCs from Crown Laboratories, Inc. labeler code 00316

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 17 words ▾

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

⏱️ Dosage and Administration 4 words ▾

Directions Apply as needed

⚠️ 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 a Poison Control Center right away.

📦 Storage and Handling 11 words ▾

Other information store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]

🧪 Active Ingredient 5 words ▾

Active ingredient Colloidal Oatmeal 2%

🧪 Inactive Ingredients 58 words ▾

Inactive ingredients 1,2-Hexanediol, Acetyl Heptapeptide-4, Allantoin, Bacillus Ferment, Beta-Glucan, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Acetate, Citric Acid, Dimethicone, Fructose, Glucose, Glycerin, Glyceryl Stearate, Hydroxyacetophenone, Maltose, Pentylene Glycol, Simmondsia Chinesis (Jojoba) Seed Oil, Sodium Chloride, Sodium Hyaluronate, Sodium Hydroxide, Sodium Lactate, Sodium PCA, Trehalose, Triceteareth-4 Phosphate, Urea, Water

🎯 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 ↗

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 Crown Laboratories, Inc.. 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 1 other package presentation of this same product, including 222 ml (00316-0256-75). 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?
Crown Laboratories, Inc. 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.
← 00316-0255-01 · Crown 00316-0264-04 · Crown →
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.