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Baby XtraCare Oatmeal Dimethicone 1.2 g/100g Lotion, 227 g — NDC 57337-0070-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Baby XtraCare Oatmeal Dimethicone 1.2 g/100g Lotion, 227 g — NDC 57337-070-01 (Billing 57337-0070-01)

by Rejoice International · 227 g in 1 BOTTLE

This is a package of 227 g of Baby XtraCare Oatmeal Dimethicone 1.2 g/100g Lotion from Rejoice International, marketed since Feb 2015 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 57337-0070-01
🏷️ FDA NDC (as labeled) 57337-070-01 billing pads the product segment with a zero
This package
Contains227 g Pack sizes2 compare ↓
Main listing for product 57337-070 · Also comes in: 354 g 57337-070-02
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 →
⚠️
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) 57337-070-01
Product NDC 57337-070
11-digit billing NDC 57337007001
RxCUI 876980
UNII 92RU3N3Y1O
UPC 0849607058317, 0849607058348
Application # M016
SPL Set ID 0049462b-ff31-440f-9244-b61153625bca
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 2015-02-16
Route TOPICAL
Dosage form LOTION
Substance DIMETHICONE
Quick answers
  • RxCUI (RxNorm): 876980
Why two NDCs? The FDA registers this code as 57337-070-01 — 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 → 57337-0070-01. 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?

Baby XtraCare Oatmeal Dimethicone is an over-the-counter lotion applied to the skin. It contains dimethicone, a silicone-based ingredient commonly used in skincare products to form a protective barrier on the skin surface. This lotion is marketed as an OTC monograph product, meaning it follows FDA's standard rules for this category of skin protectants rather than undergoing individual product review.

Supplement & herbal interactions

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

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: 354 g
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
57337-0070-01 You're viewing this Main listing 227 g in 1 BOTTLE 2025-01-01 — Active
57337-0070-02 57337-070-02 354 g in 1 BOTTLE 2025-01-01 — 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 227 g — 227 g in 1 bottle.
How does this package differ from NDC 57337-0070-02?
Both are Baby XtraCare Oatmeal Dimethicone 1.2 g/100g Lotion — the drug itself is identical. This page's package is the 227 g one, while NDC 57337-0070-02 is the 354 g package.
What NDC number is used to bill for this package of Baby XtraCare Oatmeal Dimethicone 1.2 g/100g 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 Moisturizer 1.2 g/100g 00363-5934-02 Walgreens 236 ml — — FDA listed —
Daily Moisturizer 1200 mg/100mL 00363-5990-18 Walgreen 511 ml — — FDA listed —
Skin Relief 1200 mg/100mL 00363-5995-18 Walgreen 511 ml — — FDA listed —
Target Up and Up Daily Moisturizing 12 mg/mL 11673-0087-18 TARGET 85 ml — — FDA listed —
Dimethicone 12 mg/g 37808-0496-34 H 227 g — — FDA listed —
Hill Country Essentials 12 mg/mL 37808-0995-43 H.E.B 532 ml — — FDA listed —
Meijer Skin Relieving Moisturizing 12 mg/mL 41250-0985-43 MEIJER 532 ml — — FDA listed —
Equate Daily Moisturizing Dimethicone Skin Protectant 12 mg/mL 49035-0575-43 Walmart 532 ml — — FDA listed —
Baby XtraCare Oatmeal 1.2 g/100gthis 57337-0070-01 Rejoice 227 g — — FDA listed —
Alike Daily Moisturizing 1.2 g/100mL 57337-0098-01 Rejoice 354 ml — — FDA listed —
Life is healed Daily Moisturizing 12 mg/mL 63148-0028-05 Apollo 532 ml — — FDA listed —
Daily Moisturizing 12 mg/g 64024-0496-34 Aldi, 227 g — — FDA listed —
Aveeno Skin Relief Moisturizing Fragrance Free 12 mg/mL 69968-0236-09 Kenvue 975 ml — — FDA listed —
Aveeno Skin Relief Moisturizing Fragrance Free 12 mg/mL 69968-0408-01 Kenvue 29 ml — — FDA listed —
Aveeno Skin Relief Moisturizing Fragrance Free 12 mg/g 69968-0409-01 Kenvue 227 g — — FDA listed —
Aveeno Baby Daily Moisture 12 mg/mL 69968-0441-01 Kenvue 532 ml — — FDA listed —
Aveeno DAILY MOISTURIZING 12 mg/mL 69968-0454-01 Kenvue 354 ml — — FDA listed —
Aveeno Baby Daily Care Set 69968-0592-01 Kenvue 1 kit — — FDA listed —
Aveeno Baby Calming Comfort 12 mg/mL 69968-0629-01 Kenvue 532 ml — — FDA listed —
Aveeno Baby Calming Comfort Bath Plus Set 69968-0631-09 Kenvue 1 kit — — FDA listed —
Aveeno Baby Daily Care Set 69968-0632-09 Kenvue 1 kit — — FDA listed —
Aveeno Baby Calming Comfort 12 mg/g 69968-0656-08 Kenvue 227 g — — FDA listed —
Aveeno Baby Daily Moisture 12 mg/g 69968-0679-08 Kenvue 227 g — — FDA listed —
Aveeno Daily Moisturizing 12 mg/g 69968-0680-04 Kenvue 71 g — — FDA listed —
Daily Moisturizing 12 mg/g 71141-0496-34 Lidl 227 g — — FDA listed —
Daily Moisturizing 12 mg/g 75712-0496-34 Old 227 g — — Discontinued —
Dimethicone 12 mg/mL 76162-0496-44 Topco 532 ml — — FDA listed —
Dimethicone 12 mg/mL 79481-0496-01 Meijer, 532 ml — — FDA listed —
Monistat Complete Care Chafing Relief 1.2 g/100g 63736-0031-01 Insight 1 tube — — 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

🏛️
2015
On the market since
Feb 2015
📍
2026
Currently FDA-listed
11 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 5P8D0Z74RG
    A finely ground grain from oats. Used as a filler and natural thickening agent to add bulk to the medicine and help it hold together in solid forms.
  • 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 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 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 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 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII E2KR9C9V2I
    Polyacrylamide is a synthetic polymer used as a thickening agent and binder in medications. It helps create the proper texture and hold ingredients together in the formulation.
  • 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.

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

The official label also statesInactive Ingredients water, petrolatum, mineral oil, glycerin, glyceryl stearate, propylene glycol, PEG-100 stearate, polyacrylamide, cetyl alcohol, avena sativa (oatmeal) kernel extract, fragrance, DMDM hydantoin, stearyl alcohol, c13-14 isoparaffin, laureth-7, disodium EDTA, 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 marketedFeb 2015
Product typeHuman Otc Drug
Portfolio40 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.

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 26 words ▾

Baby XtraCare® Oatmeal Daily Moisturizing Lotion Lightly Scented Dimethicon Skin Protectant with Natural Oat Extract Helps Soothe & Soften Baby's Skin 12 FL OZ (354 mL)

⏱️ Dosage and Administration 7 words ▾

Directions Apply liberally as often as needed.

⚠️ Warnings 45 words ▾

Warnings For extenal 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 7days or clear up and occur again within a few days.

🧪 Active Ingredient 8 words ▾

Active Ingredient Purpose Dimethicone 1.2% ............................ Skin Protectant

🧪 Inactive Ingredients 37 words ▾

Inactive Ingredients water, petrolatum, mineral oil, glycerin, glyceryl stearate, propylene glycol, PEG-100 stearate, polyacrylamide, cetyl alcohol, avena sativa (oatmeal) kernel extract, fragrance, DMDM hydantoin, stearyl alcohol, c13-14 isoparaffin, laureth-7, disodium EDTA, aloe barbadensis leaf juice, methylparaben, propylparaben.

🎯 Purpose 11 words ▾

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

📄 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 20 words ▾

Other Information Store at room temperature. Questions/Comments? 1-855-345-5575 DISTRIBUTED BY REJOICE INTERNATIONAL INC NORTHVILLE, MI 48168 U.S.A. MADE IN CHINA

📄 Package Label / Principal Display Panel 6 words ▾

8oz label image 12oz label image

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

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 Dimethicone — the ingredient across all brands.

Top reported reactions

Diarrhoea6,548
Nausea3,155
Fatigue2,650
Vomiting2,189
Constipation1,812
Weight Decreased1,550
Abdominal Pain1,404

Age at onset

Neonate12
Infant18
Child55
Adolescent75
Adult3,068
Elderly4,698

Reporter sex

32,731 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization11,670
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 2,451 790
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.

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 354 g (57337-0070-02). 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.
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.