Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Aveeno Baby Calming Comfort Dimethicone 12 mg/mL Lotion, 532 mL — NDC 69968-0629-1 (Billing 69968-0629-01)
by Kenvue Brands LLC · 532 mL in 1 BOTTLE, PUMP
This is a package of 532 mL of Aveeno Baby Calming Comfort Dimethicone 12 mg/mL Lotion from Kenvue Brands LLC, marketed since Jun 2020 and currently FDA-listed. It is this product's only package size.
NDC 69968-0629-01
🏷️ FDA NDC (as labeled)
69968-0629-1
billing pads the package segment with a zero
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 69968-0629-1 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 69968 labeler · 0629 product · 1 package
- Package marketed since
- Jun 1, 2020
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 6996806291 9
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
69968-0629-1
Product NDC
69968-0629
11-digit billing NDC
69968062901
RxCUI
876980
UNII
92RU3N3Y1O
Application #
M016
SPL Set ID
567b1481-b783-45f9-af38-5630c9edf044
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
2020-06-01
Route
TOPICAL
Dosage form
LOTION
Substance
DIMETHICONE
Quick answers
- RxCUI (RxNorm): 876980
Why two NDCs?
The FDA registers this code as 69968-0629-1 — 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 → 69968-0629-01. 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
🧪 What is this product?
Aveeno Baby Calming Comfort is a topical lotion containing dimethicone, a silicone-based ingredient. Dimethicone is commonly used in baby skincare products to help protect and soothe the skin by forming a moisture-trapping barrier on the surface. This is an over-the-counter product marketed under FDA's monograph rules for its ingredient category rather than as an individually reviewed drug application.
Patient education
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.
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
💬 Questions about Dimethicone?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per g | Per 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 69968-0629-01 You're viewing this Main listing | 532 mL in 1 BOTTLE, PUMP | 2020-06-01 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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/100g 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/mLthis 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 | — |
| Aveeno Baby Daily Moisture with Coconut Oil and Shea Butter 12 mg/mL 69968-0762-01 | Kenvue | 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2020
On the market since
Jun 2020
📍
2026
Currently FDA-listed
6 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.
- FDA Orange Book · refreshed Oct 3, 2026
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 LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
-
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 OM9573ZX3X
A synthetic compound used as an antistatic agent and conditioner in solid dosage forms. It reduces friction and helps powders flow smoothly during manufacturing and tablet compression.
-
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 8CRQ2TH63M
Isopropyl palmitate is an oily liquid derived from palm oil. It acts as an emollient and lubricant in medicines, helping soften the skin or improve how the product spreads and flows.
-
UNII 8PI54V663Y
Oatmeal is ground oat grain used as a natural filler and texture agent in medicines. It absorbs moisture, adds bulk to the formulation, and may help create a soothing base in topical products.
-
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 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 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.
9 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesWater, Glycerin, Distearyldimonium Chloride,Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Fragrance, Sodium Chloride
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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
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 marketedJun 2020
Product typeHuman Otc Drug
Portfolio567 products on file
More NDCs from Kenvue Brands LLC labeler code 69968
- Neutrogena Sheer Zinc Mineral Sunscreen Broad Spectrum SPF 50 Zinc Oxide 216 mg/mL Lotion NDC 69968-0613-2
- BENGAY Tropical Jasmine Lidocaine 40 mg/g Cream NDC 69968-0614-3
- Neutrogena Oil Free Moisture Broad Spectrum SPF15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone 40 mg/mL; 15 mg/mL; 50 mg/mL; 30 mg/mL Lotion NDC 69968-0616-2
- Neutrogena Sheer Zinc Face Mineral Sunscreen Broad Spectrum SPF 50 Zinc Oxide 216 mg/mL Lotion NDC 69968-0623-2
- Benadryl Original Strength Itch Stopping Diphenhydramine Hydrochloride and Zinc Acetate 10 mg/g; 1 mg/g Cream NDC 69968-0625-1
- Neutrogena Body Clear Body Scrub Salicylic Acid 20 mg/mL Suspension NDC 69968-0628-9
- Aveeno Baby Calming Comfort Bath Plus Set Dimethicone Kit NDC 69968-0631-9
- Aveeno Baby Daily Care Set Dimethicone Kit NDC 69968-0632-9
- Neutrogena Body Clear Body Wash Pink Grapefruit Salicylic Acid 20 mg/mL Suspension NDC 69968-0633-9
- Neosporin Original Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate 400 [iU]/g; 3.5 mg/g; 5000 [iU]/g Ointment NDC 69968-0634-1
- Aveeno Restorative Skin Therapy Itch Relief Balm PRAMOXINE HYDROCHLORIDE 5 mg/g Cream NDC 69968-0637-4
- Neutrogena Stubborn Acne AM Treatment Benzoyl Peroxide 25 mg/g Gel NDC 69968-0653-1
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 openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
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
📄 Do Not Use
📄 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 ▾
Uses Temporarily protects and helps relieve chafed, chapped, or cracked skin Helps prevent and protect from the drying effects of wind and cold weather.
⏱️ Dosage and Administration ▾
Directions Apply as needed.
⚠️ Warnings ▾
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. Do not use on Deep or puncture wounds Animal bites Serious burns . Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other information Store at room temperature. Remove quality seal. Do not use if quality seal is broken.
🧪 Active Ingredient ▾
Active ingredient Dimethicone 1.2%
🧪 Inactive Ingredients ▾
Inactive ingredients Water , Glycerin, Distearyldimonium Chloride ,Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Fragrance, Sodium Chloride
🎯 Purpose ▾
Purpose Skin protectant
📄 Do Not Use ▾
Do not use on Deep or puncture wounds Animal bites Serious burns .
📄 When Using This Product ▾
When using this product Do not get into eyes.
📄 Stop Use and Ask a Doctor If ▾
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 ▾
Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.
📄 Questions or Comments ▾
Questions? 866-428-3366; Outside US, dial collect 215-273-8755 visit www.aveeno.com
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 532 mL Bottle Label RECOMMENDED BY PEDIATRICIANS & DERMATOLOGIST Aveeno ® New Look baby New Gentle Fragrance calming comfort ® lotion natural oatmeal + lavender scent dimethicone skin protectant moisturizes baby's skin for 24hrs helps calm baby before bedtime lavender & vanilla scented 18 FL OZ (532 mL) PRINCIPAL DISPLAY PANEL - 532 mL Bottle Label
No label section mentions that — try another word, or open the full label on DailyMed below.
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
Age at onset
Reporter sex
Male · 37%
Female · 63%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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.
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.
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.