HomeNDC LookupIngredientsColloidal Oatmeal › 54136-0183-24
Calming Itch and Irritation Colloidal Oatmeal 2 g/100g Lotion, 239 g — NDC 54136-0183-24 package photo

Calming Itch and Irritation Colloidal Oatmeal 2 g/100g Lotion, 239 g

by Better Planet Brands LLC · 239 g in 1 TUBE (54136-183-24)
NDC 54136-0183-24
🏷️ FDA NDC (as labeled) 54136-183-24 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 →

🆔 Identity & classification

FDA NDC (as labeled) 54136-183-24
Product NDC 54136-183
11-digit billing NDC 54136018324
RxCUI 1591951
UNII 8PI54V663Y
Application # M016
SPL Set ID 1dd7e712-56a4-86c0-e063-6294a90a75cd
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 2024-07-31
Route TOPICAL
Dosage form LOTION
Substance OATMEAL
Why two NDCs? The FDA registers this code as 54136-183-24 — 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 → 54136-0183-24. 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

LabelerBetter Planet Brands LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code54136
First marketedJul 2024
Product typeHuman Otc Drug
Portfolio8 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 lotion containing colloidal oatmeal, an over-the-counter monograph product marketed for itching and skin irritation. Colloidal oatmeal is commonly used in skin care products to help soothe and calm inflamed or uncomfortable skin. The lotion form is applied directly to affected areas of the skin. This product is regulated under the FDA's established rules for over-the-counter skin protectants and itch-relief products.

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 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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • 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 MC2LH51BO7
    A plant-derived oil extracted from chia seeds, used as an emollient and vehicle in topical or oral formulations. It helps deliver active ingredients and may improve product texture or absorption.
  • UNII ISE9I7DNUG
    Cocoglycerides are fatty substances derived from coconut oil. They act as emulsifiers and solubilizers in medicines, helping blend water and oil-based ingredients together and improve how the body absorbs certain drugs.
  • UNII 512OYT1CRR
    Cocoa butter is a natural fat extracted from cocoa beans. It's used in medicines as a base for suppositories and as a lubricant to help pills dissolve smoothly.
  • 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 Y98611C087
    Glyceryl laurate is an emulsifier made by combining glycerin and lauric acid. It helps mix oil and water-based ingredients together in the medicine and may improve how the product feels or spreads.
  • UNII FCZ5MH785I
    A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
  • UNII T53SBG6741
    A plant-based oil extracted from sea buckthorn seeds. It's used as an emollient and skin-conditioning agent to soften the medicine's texture and improve how it feels or spreads on skin.
  • UNII 412ZHA4T4Y
    A plant-derived oil extracted from meadowfoam seeds. It acts as an emollient and skin-conditioning agent, helping soften and smooth the product texture while improving how it spreads on skin.
  • UNII 6UYK2W1W1E
    A natural oil extracted from olives. It acts as an emollient and lubricant in formulations, helping to soften ingredients and improve how the medicine spreads or flows.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII M437LS0K52
    Quinoa oil is a plant-based oil extracted from quinoa seeds. It's used in medicines as an emollient and carrier to help dissolve or suspend active ingredients and improve product texture and skin feel.
  • UNII 65UEH262IS
    Safflower oil is a plant-based oil extracted from safflower seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients, and sometimes as an emollient to improve texture.
  • 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 VK44E1MQU8
    Sodium levulinate is a salt derived from levulinic acid, a naturally occurring organic compound. It functions as a humectant and preservative in medicines, helping retain moisture and prevent microbial growth.
  • 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 GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesWATER, ALOE BARBADENSIS LEAF JUICE POWDER*, CETEARYL OLIVATE, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, THEOBROMA CACAO (COCOA) SEED BUTTER*, LIMNANTHES ALBA (MEADOWFOAM) SEED OIL, SORBITAN OLIVATE, GLYCERIN, COCOGLYCERIDES, GLYCERYL STEARATE SE, TOCOPHEROL, HIPPOPHAE RHAMNOIDES FRUIT OIL*, BUTYROSPERMUM PARKII (SHEA) BUTTER, OLEA EUROPABA (OLIVE) FRUIT OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, SALVIA HISPANICA SEED OIL, CHENOPODIUM QUINOA SEED OIL, XANTHAN GUM, SQUALANE, SODIUM LEVULINATE, GLYCERYL LAURATE, POTASSIUM SORBATE, CITRIC ACID.

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 DailyMedingredient 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.
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
Sarna 20 mg/mL 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/100gthis 54136-0183-24 Better 239 g FDA listed
MG217 Eczema Face .02 g/g 68093-7245-01 Wisconsin 170 g FDA listed
Evereden Intensive Eczema Balm 2 g/100g 72113-0109-21 Eden 1 jar FDA listed
TCX Skincare 2 g/100g 49449-0100-01 Theraceutix, 59 g FDA listed
Nizoral Eczema Relief Cream 2 g/100g 55505-0223-33 Kramer 1 bottle FDA listed
Cetaphil Eczema Rapid Relief Cream 2 g/100g 00299-4144-00 Galderma 227 g FDA listed
Gold Bond Eczema Relief Medicated Hand Cream 2 g/100g 84714-0668-00 Gold 85 g FDA listed
Gold Bond Eczema Relief Medicated Skin Protectant Cream 2 g/100g 84714-0669-01 Gold 121 g FDA listed
Gold Bond Eczema Relief Medicated Hand Cream 2 g/100g 41167-0668-00 Chattem, 85 g FDA listed
Gold Bond Eczema Relief Medicated Skin Protectant Cream 2 g/100g 41167-0669-01 Chattem, 121 g FDA listed
OKeeffes Skin Repair Body Cream Eczema Relief 2 g/100g 71564-0010-98 The 198 g FDA listed
Eczema Skin Relief Cream 2 g/100g 51316-0860-01 CVS 227 g FDA listed
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2024
On the market since
Jul 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
54136-0183-24 You're viewing this 239 g in 1 TUBE (54136-183-24) 2024-07-31 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 ✓ 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 54136-183-24, 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: 54136-0183-24, written without dashes as 54136018324. 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 54136-0183-24, the first segment (54136) is the labeler code FDA assigned to Better Planet Brands LLC; the middle segment (0183) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (24) 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 Better Planet Brands LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Better Planet Brands 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 24 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 58 words

Warnings For external use When using this product Do not get into eyes Stop use and ask 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 product is swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words

Active Ingredients Colloidal Oatmeal 2.0%

🧪 Inactive Ingredients 70 words

Inactive ingredients WATER, ALOE BARBADENSIS LEAF JUICE POWDER*, CETEARYL OLIVATE, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, THEOBROMA CACAO (COCOA) SEED BUTTER*, LIMNANTHES ALBA (MEADOWFOAM) SEED OIL, SORBITAN OLIVATE, GLYCERIN, COCOGLYCERIDES, GLYCERYL STEARATE SE, TOCOPHEROL, HIPPOPHAE RHAMNOIDES FRUIT OIL*, BUTYROSPERMUM PARKII (SHEA) BUTTER, OLEA EUROPABA (OLIVE) FRUIT OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, SALVIA HISPANICA SEED OIL, CHENOPODIUM QUINOA SEED OIL, XANTHAN GUM, SQUALANE, SODIUM LEVULINATE, GLYCERYL LAURATE, POTASSIUM SORBATE, CITRIC ACID.

🎯 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 ↗
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.