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XtraCare with cooling action Oatmeal Skin Relief Calmin Dimethicone 5 mg/354mg Lotion, 354 mg — NDC 57337-0038-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

XtraCare with cooling action Oatmeal Skin Relief Calmin Dimethicone 5 mg/354mg Lotion, 354 mg — NDC 57337-038-01 (Billing 57337-0038-01)

by Rejoice International · 354 mg in 1 BOTTLE

This is a package of 354 mg of XtraCare with cooling action Oatmeal Skin Relief Calmin Dimethicone 5 mg/354mg Lotion from Rejoice International, marketed since Nov 2013 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 57337-0038-01
🏷️ FDA NDC (as labeled) 57337-038-01 billing pads the product segment with a zero
This package
Contains354 mg Pack sizes2 compare ↓
Main listing for product 57337-038 · Also comes in: 227 mg 57337-038-02
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 57337-038-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
57337 labeler · 038 product · 01 package
Package marketed since
Nov 26, 2013
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0849607052988
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Dimethicone (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 11, 2026 — Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification. (BioMed Laboratories, LLC.) · FDA recall D-0663-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 57337-038-01
Product NDC 57337-038
11-digit billing NDC 57337003801
RxCUI 891710
UNII 92RU3N3Y1O
UPC 0849607052988
Application # M016
SPL Set ID f99606f6-83bc-436e-aa21-53e77eb87b9c
Physiologic effect Skin Barrier Activity
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-11-26
Route TOPICAL
Dosage form LOTION
Substance DIMETHICONE
Quick answers
  • RxCUI (RxNorm): 891710
Why two NDCs? The FDA registers this code as 57337-038-01 — 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 → 57337-0038-01. 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 Other ectoparasiticides, incl. scabicides class.

Drug family (ATC) Other ectoparasiticides, incl. scabicides
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?

This is a topical lotion marketed as an over-the-counter monograph product for skin care. It contains dimethicone, a silicone-based ingredient commonly used in skin relief products to form a protective barrier on the skin surface. The product is formulated with oatmeal, which is traditionally included in lotions meant to soothe and calm irritated skin. This type of product is typically applied directly to affected areas of the skin.

Supplement & herbal interactions

Some supplements/herbs that may interact with Dimethicone — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Dimethicone (3 interactions) — ranked by severity →
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: 227 mg
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
57337-0038-01 You're viewing this Main listing 354 mg in 1 BOTTLE 2013-11-26 — Active
57337-0038-02 57337-038-02 227 mg in 1 BOTTLE 2013-11-26 — Active

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

Pack size FAQ

What quantity is in this package?
This package contains 354 mg — 354 mg in 1 bottle.
How does this package differ from NDC 57337-0038-02?
Both are XtraCare with cooling action Oatmeal Skin Relief Calmin Dimethicone 5 mg/354mg Lotion — the drug itself is identical. This page's package is the 354 mg one, while NDC 57337-0038-02 is the 227 mg package.
What NDC number is used to bill for this package of XtraCare with cooling action Oatmeal Skin Relief Calmin Dimethicone 5 mg/354mg 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
Daily Moisturizing 13 mg/g 00363-0619-18 Walgreen 71 g — — Discontinued —
Daily Moisturizing 13 mg/mL 11822-0619-01 Rite 354 ml — — Discontinued —
Oatmeal 13 mg/mL 21130-0898-32 Better 354 ml — — FDA listed —
Daily Moisturizing 13 mg/mL 30142-0619-44 The 532 ml — — FDA listed —
Daily Moisturizing 13.13 mg/mL 36800-0619-40 Topco 354 ml — — FDA listed —
Daily Moisturizing 13 mg/mL 41250-0619-40 Meijer, 354 ml — — FDA listed —
Daily Moisturizing 1.3 kg/100mL 55301-0619-40 Your 354 ml — — FDA listed —
Daily Moisturizing 13 mg/mL 56062-0619-34 Publix 227 ml — — Discontinued —
XtraCare Skin Relief Oatmeal Daily Moisturizing 5 mg/354mg 57337-0037-01 Rejoice 354 mg — — FDA listed —
XtraCare with cooling action Oatmeal Skin Relief Calmin 5 mg/354mgthis 57337-0038-01 Rejoice 354 mg — — FDA listed —
XtraCare Skin Relief Oatmeal Daily Moisturizing 3 g/227g 57337-0054-01 Rejoice 227 g — — FDA listed —
XtraCare with cooling action Oatmeal Skin Relief Calmin 3 g/227g 57337-0055-01 Rejoice 227 g — — FDA listed —
Oatmeal Skin Relief Calming . 8oz 3 g/227g 57337-0100-01 Rejoice 227 g — — FDA listed —
XtraCare Oatmeal Daily Moisturizing 8 oz 1.3 g/100g 57337-0138-01 Rejoice 227 g — — FDA listed —
XtraCare Oatmeal Daily Moisturizing 8 oz 1.3 g/100g 57337-0139-01 Rejoice 227 g — — FDA listed —
Harmon Daily Moisturzier 13 mg/mL 63940-0074-03 HARMON 85 ml — — FDA listed —
Daily Moisturizing 13.13 mg/mL 64024-0619-44 Aldi, 532 ml — — FDA listed —
Daily Moisturizing 1.3 kg/100mL 69842-0771-40 CVS 354 ml — — Discontinued —
Daily Moisturizing 1.3 kg/100mL 71141-0619-44 Lidl 532 ml — — FDA listed —
Daily Moisturizing 13 mg/g 72288-0619-34 Amazon.com 227 g — — Discontinued —
Daily Moisturizing 13 mg/mL 72476-0619-40 Retail 354 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

🏛️
2013
On the market since
Nov 2013
📍
2026
Currently FDA-listed
13 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.

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 E4F12ROE70
    A refined mineral oil derived from crude petroleum containing 13 to 14 carbon chains. It acts as a solvent, emollient, and carrier in topical formulations to help dissolve active ingredients and improve product texture and spreadability.
  • 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 BYR0546TOW
    DMDM hydantoin is a preservative chemical used to prevent the growth of bacteria and fungi in medicines. It helps keep the product safe and stable throughout its shelf life.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 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 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII Z95S6G8201
    A synthetic surfactant derived from lauryl alcohol and ethylene oxide. It helps dissolve and mix oily and watery ingredients in liquid formulations, and may improve how the medicine spreads or is absorbed.
  • UNII L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII Z6J799EAJK
    Oat is a cereal grain used in medicines as a filler and binder. It helps give the medication its shape and structure while adding bulk to the formulation.
  • 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 5D6TC4BRWV
    Polyacrylamide is a synthetic polymer used as a thickener and stabilizer in medicines. It helps maintain consistent texture and prevents separation of ingredients in liquid or semi-solid formulations.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • 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.

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

The official label also statesInactive Ingredients water, paraffinum liquidum, isopropyl myristate, glycerin, glyceryl stearate, propylene glycol, PEG-100 stearate, polyacrylamide, cetyl alcohol, avena sativa kernel extract, fragrance, DMDM hydantoin, stearyl alcohol, c13-14 isoparaffin, laureth-7, disodium EDTA, menthol, aloe barbadensis leaf juice, methylparaben, propylparaben.

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

LabelerRejoice International
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code57337
First marketedNov 2013
Product typeHuman Otc Drug
Portfolio40 products on file

More NDCs from Rejoice International labeler code 57337

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 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 11 words ▾

Use Help prevent and temporarily protects chafed, chapped, or cracked skin.

⏱️ Dosage and Administration 7 words ▾

Directions apply liberally as often as needed.

⚠️ Warnings 46 words ▾

Warnings For external use only. When using this product avoid contact with eyes. In case of eye contact, flush with water. 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.

🧪 Active Ingredient 8 words ▾

Active Ingredient Purpose Dimethicone 1/3% ......... Skin Protectant

🧪 Inactive Ingredients 38 words ▾

Inactive Ingredients water, paraffinum liquidum, isopropyl myristate, glycerin, glyceryl stearate, propylene glycol, PEG-100 stearate, polyacrylamide, cetyl alcohol, avena sativa kernel extract, fragrance, DMDM hydantoin, stearyl alcohol, c13-14 isoparaffin, laureth-7, disodium EDTA, menthol, aloe barbadensis leaf juice, methylparaben, propylparaben.

🎯 Purpose 32 words ▾

XtraCare (with cooling action) Oatmeal Skin Relief Calming Lotion dimethicone skin protectant with natural colloidal oatmeal provides immediate and lasting moisture relief for itchy, extra dry skin 12 fl oz (354 mL)

📄 Keep Out of Reach of Children 18 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

📄 Other Information 21 words ▾

Other Information store at room temperature. DISTRIBUTED BY: REJOICE INTERNATIONAL INC. 48325 BINGHAMPTON DR., NORTHVILLE, MI 48168 USA MADE IN CHINA

📄 Package Label / Principal Display Panel 2 words ▾

label label

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 Rejoice International. 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 227 mg (57337-0038-02). 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?
Rejoice International 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.
← 57337-0037-01 · Rejoice 57337-0039-01 · Rejoice →
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.