Home › NDC Lookup › Ingredients › Oatmeal › 69968-0541-03
Aveeno Baby Eczema Therapy Soothing Bath Treatment Oatmeal 430 mg/g Powder — NDC 69968-0541-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Aveeno Baby Eczema Therapy Soothing Bath Treatment Oatmeal 430 mg/g Powder — NDC 69968-0541-3 (Billing 69968-0541-03)

by Kenvue Brands LLC · 5 PACKET in 1 CARTON / 21 g in 1 PACKET

This is a package of Aveeno Baby Eczema Therapy Soothing Bath Treatment Oatmeal 430 mg/g Powder from Kenvue Brands LLC, marketed since Jan 2012 and currently FDA-listed.

NDC 69968-0541-03
🏷️ FDA NDC (as labeled) 69968-0541-3 billing pads the package segment with a zero
This package
Contains21 g in 1 packet Pack sizes2 compare ↓
Product page 69968-0541-01 Also comes in: 10 packets 69968-0541-1
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 69968-0541-3 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69968 labeler · 0541 product · 3 package
Package marketed since
Jan 1, 2012
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0381370036623
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69968-0541-3
Product NDC 69968-0541
11-digit billing NDC 69968054103
UNII 8PI54V663Y
UPC 0381370036623
Application # M016
SPL Set ID e7eb10b7-3950-49cb-ba73-11e7581b6be9
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 2012-01-01
Route TOPICAL
Dosage form POWDER
Substance OATMEAL
Why two NDCs? The FDA registers this code as 69968-0541-3 — a 5-4-1 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 package segment → 69968-0541-03. 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.

Clinical

🧪 What is this product?

Aveeno Baby Eczema Therapy is a powder intended to be stirred into bathwater as a topical treatment. The active ingredient is colloidal oatmeal, a finely ground form of oatmeal that is commonly used in bath products to help soothe and moisturize irritated or itchy skin. This product is an over-the-counter monograph drug, meaning it is marketed under FDA guidelines for its category rather than as an individually reviewed application.

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: 10 packets
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
69968-0541-01 69968-0541-1 Main listing 10 PACKET in 1 CARTON / 21 g in 1 PACKET 2019-03-25 — Discontinued by firm
69968-0541-03 You're viewing this 5 PACKET in 1 CARTON / 21 g in 1 PACKET 2012-01-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 5 packet in 1 carton / 21 g in 1 packet.
What NDC number is used to bill for this package of Aveeno Baby Eczema Therapy Soothing Bath Treatment Oatmeal 430 mg/g Powder?
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
Aveeno Baby Eczema Therapy Soothing Bath Treatment 430 mg/gthis 69968-0541-03 Kenvue 5 packets — — 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

🏛️
2012
On the market since
Jan 2012
📍
2026
Currently FDA-listed
14 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 S4255P4G5M
    Calcium silicate is a white powder made from calcium and silicon compounds. It acts as an anti-caking agent and flow aid, helping powder ingredients move smoothly during tablet or capsule manufacturing.
  • UNII 6HQ855798J
    Laureth-4 is a synthetic detergent made from lauryl alcohol and ethylene oxide. It acts as an emulsifier and solubilizer, helping blend oil and water-based ingredients and improve how the body absorbs the active drug.
  • 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.

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

The official label also statesmineral oil, calcium silicate, laureth-4

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

LabelerKenvue Brands LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code69968
First marketedJan 2012
Product typeHuman Otc Drug
Portfolio567 products on file

More NDCs from Kenvue Brands LLC labeler code 69968

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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 22 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 96 words ▾

Directions For dispersal in water: Turn warm water faucet on to full force. Slowly sprinkle packet of colloidal oatmeal directly under the faucet into the tub or container. Stir any colloidal oatmeal settled on the bottom.

For use as a soak in a bath: Slowly sprinkle one packet in an infant tub filled with warm water. Stir any colloidal oatmeal that may have settled on the bottom. Soak affected area for 15 to 30 minutes as needed, or as directed by a doctor.

Pat dry (do not rub) to keep a thin layer on the skin.

⚠️ Warnings 77 words ▾

Warnings For external use only. When using this product Do not get into eyes. To avoid slipping, use mat in tub or shower. In some skin conditions, soaking too long may overdry. 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 6 words ▾

Other information Store at room temperature.

🧪 Active Ingredient 5 words ▾

Active ingredient Colloidal oatmeal 43%

🧪 Inactive Ingredients 7 words ▾

Inactive ingredients mineral oil, calcium silicate, laureth-4

🎯 Purpose 3 words ▾

Purpose Skin protectant

📄 When Using This Product 27 words ▾

When using this product Do not get into eyes. To avoid slipping, use mat in tub or shower. In some skin conditions, soaking too long may overdry.

📄 Stop Use and Ask a Doctor If 25 words ▾

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 20 words ▾

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

📄 Questions or Comments 8 words ▾

Questions? 866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

📄 Package Label / Principal Display Panel 58 words ▾

PRINCIPAL DISPLAY PANEL - 106 g Packet Carton RECOMMENDED BY PEDIATRICIANS & DERMATOLOGISTS Aveeno ® baby eczema therapy soothing bath treatment colloidal oatmeal skin protectant relieves dry, itchy, irritated skin due to: eczema, rashes, poison ivy/oak/sumac, insect bites fragrance-free, allergy-tested steroid-free ACCEPTED e NATIONALECZEMA.ORG NATIONAL ECZEMA ASSOCIATION 5 Bath Packets TOTAL NET WT.

3.75 OZ (106 g) Aveeno

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 Aveeno Baby Eczema Therapy Soothing Bath Treatment (this brand).

Top reported reactions

Rash4
Weight Decreased3
Abdominal Pain2
Anaemia2
Anal Incontinence2
Diarrhoea2
Abdominal Discomfort1

Reporter sex

0 reports

Serious outcomes

Hospitalization6
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 2 0
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 Kenvue Brands LLC. 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 10 packets (69968-0541-01). 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?
Kenvue 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.
← 69968-0540-01 · Kenvue 69968-0547-01 · Kenvue →
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.