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Cetaphil Cracked Skin Repair Dimethicone 20 mg/mL Lotion, 473 mL — NDC 00299-4114-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cetaphil Cracked Skin Repair Dimethicone 20 mg/mL Lotion, 473 mL — NDC 0299-4114-00 (Billing 00299-4114-00)

by Galderma Laboratories, L.P. · 473 mL in 1 BOTTLE, PUMP

This is a package of 473 mL of Cetaphil Cracked Skin Repair Dimethicone 20 mg/mL Lotion from Galderma Laboratories, L.P., marketed since May 2021 and currently FDA-listed. It is this product's only package size.

NDC 00299-4114-00
🏷️ FDA NDC (as labeled) 0299-4114-00 billing pads the labeler segment with a zero
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 0299-4114-00 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0299 labeler · 4114 product · 00 package
Package marketed since
May 1, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0299411400 9
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) 0299-4114-00
Product NDC 0299-4114
11-digit billing NDC 00299411400
RxCUI 198605
UNII 92RU3N3Y1O
Application # M016
SPL Set ID 27d74e0f-8359-4c59-bf7f-acade7f4545c
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 2021-05-01
Route TOPICAL
Dosage form LOTION
Substance DIMETHICONE
Quick answers
  • RxCUI (RxNorm): 198605
Why two NDCs? The FDA registers this code as 0299-4114-00 — a 4-4-2 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 labeler segment → 00299-4114-00. 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?

Cetaphil Cracked Skin Repair is an over-the-counter lotion applied to the skin that contains dimethicone as its active ingredient. Dimethicone is a silicone-based ingredient commonly used in skin care products to form a protective barrier on the skin surface. This product is marketed under FDA's monograph rules for skin protectant ingredients and is typically used to help soothe and protect areas of dry or cracked 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.
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
00299-4114-00 You're viewing this Main listing 473 mL in 1 BOTTLE, PUMP 2021-05-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cetaphil Cracked Skin Repair 20 mg/mLthis 00299-4114-00 Galderma 473 ml — — FDA listed —
Baza Cleanse and Protect 20 mg/g 11701-0047-05 Coloplast 227 g — — FDA listed —
Baza Cleanse and Protect Odor Control 20 mg/g 11701-0062-05 Coloplast 227 g — — FDA listed —
Medline 2 g/100mL 53329-0251-18 Medline 237 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

🏛️
2021
On the market since
May 2021
📍
2026
Currently FDA-listed
5 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerGalderma Laboratories, L.P.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code00299
First marketedMay 2021
Product typeHuman Otc Drug
Portfolio50 products on file

More NDCs from Galderma Laboratories, L.P. labeler code 00299

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 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 39 words ▾

Uses ● helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin ● temporary protects minor: ● cuts ● scrapes ● burns ● helps prevent and protect from the drying effects of wind and cold weather

⏱️ Dosage and Administration 9 words ▾

Directions ● Apply generously to affected area as needed

⚠️ Warnings 76 words ▾

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.

🧪 Active Ingredient 5 words ▾

Active ingredients......Purpose Dimethicone 2%......Skin protectant

🧪 Inactive Ingredients 32 words ▾

Inactive Ingredients CAPRYLIC/CAPRIC TRIGLYCERIDE, HYDROGENATED CASTOR OIL, LACTIC ACID, METHOXY PEG-22/DODECYL GLYCOL COPOLYMER, METHYLPARABEN, MINERAL OIL, OZOKERITE, PEG-2 HYDROGENATED CASTOR OIL, PEG-7 HYDROGENATED CASTOR OIL, PROPYLPARABEN, SODIUM LACTATE, SORBITAN ISOSTEARATE, UREA, WATER

📄 Questions or Comments 25 words ▾

Questions or comments? 1-866-735-4137 Distributed By: Galderma Laboratories, L.P. Dallas, TX 75201 All trademarks are the property of their respective owners. Made in Canada cetaphil.com

📄 Package Label / Principal Display Panel 56 words ▾

PRINCIPLE DISPLAY PANEL - 16 FL OZ pump label Dermatologist Recommended For Sensitive Skin Cetaphil ® Cracked Skin Repair Lotion Skin Protectant Dimethicone Rough, Cracked Sensitive Skin Daily use lotion is designed to hydrate and restore rough skin and prevent cracked skin from coming back. Urea 5 skin sensitivity signs 16 FL OZ (473 mL) P56383-1

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 Cetaphil Cracked Skin Repair (this brand).

Top reported reactions

Vomiting56
Diarrhoea52
Abdominal Pain49
Pyrexia48
Nausea47
Pneumonia41
Decreased Appetite35

Age at onset

Child5
Adolescent5
Adult59
Elderly63

Reporter sex

676 reports
Male · 49%
Female · 51%
Unknown · 0%

Serious outcomes

Hospitalization408
Life-threatening60
Disabling14
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 114 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 Galderma Laboratories, L.P.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Galderma Laboratories, L.P. 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.
← 00299-4113-05 · Galderma 00299-4115-00 · Galderma →
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.