Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Cetaphil Healing petrolatum 715 mg/g Ointment, 340 g — NDC 0299-4116-10 (Billing 00299-4116-10)
by Galderma Laboratories, L.P. · 340 g in 1 JAR
This is a package of 340 g of Cetaphil Healing petrolatum 715 mg/g Ointment from Galderma Laboratories, L.P., marketed since May 2021 and currently FDA-listed.
NDC 00299-4116-10
🏷️ FDA NDC (as labeled)
0299-4116-10
billing pads the labeler segment with a zero
This package
Contains340 g
Pack sizes3 compare ↓
🗂️ 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 →
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
0299-4116-10
Product NDC
0299-4116
11-digit billing NDC
00299411610
RxCUI
686452
UNII
4T6H12BN9U
Application #
M016
SPL Set ID
e996db17-bd4d-4b06-bb9a-983dbdec8022
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
OINTMENT
Substance
PETROLATUM
Quick answers
- RxCUI (RxNorm): 686452
Why two NDCs?
The FDA registers this code as 0299-4116-10 — 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 → 00299-4116-10. 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 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
🧪 What is this product?
Cetaphil Healing is an over-the-counter topical ointment containing petrolatum as its active ingredient. Petrolatum is commonly used as an occlusive moisturizer and skin protectant, functioning to seal in moisture and create a barrier on the skin. This product is marketed as an OTC monograph drug, meaning it follows FDA guidelines for its category rather than being individually approved through a separate application.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Petrolatum — 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 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about petrolatum?
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
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 3, 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 |
|---|---|---|---|---|
| 00299-4116-00 0299-4116-00 Main listing | 85 g in 1 TUBE | 2021-05-01 | — | Active |
| 00299-4116-10 You're viewing this | 340 g in 1 JAR | 2021-05-01 | — | Active |
| 00299-4116-15 0299-4116-15 | 10 g in 1 TUBE | 2021-05-01 | — | Active |
You're viewing the largest of 3 pack sizes for this product.
Pack size FAQ
What quantity is in this package?
This package contains 340 g — 340 g in 1 jar.
How does this package differ from NDC 00299-4116-15?
Both are Cetaphil Healing petrolatum 715 mg/g Ointment — the drug itself is identical. This page's package is the 340 g one, while NDC 00299-4116-15 is the 10 g package.
What NDC number is used to bill for this package of Cetaphil Healing petrolatum 715 mg/g Ointment?
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Cetaphil Healing 715 mg/gthis 00299-4116-10 | Galderma | 340 g | — | — | FDA listed | — |
| Cetaphil Baby Healing 715 mg/g 00299-4141-00 | Galderma | 340 g | — | — | FDA listed | — |
| Critic Aid Clear 710 mg/g 11701-0066-22 | Coloplast | 4 g | — | — | 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 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
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.
- 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 9E8X80D2L0
A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
-
UNII 9M64UO4C25
A synthetic oily substance used as an emollient and texture enhancer in medicines. It helps soften formulations, improves how the medicine spreads or feels on skin, and can act as a lubricant in tablets or capsules.
-
UNII XOF597Q3KY
A refined form of wax made from petroleum, microcrystalline wax is used in medicines as a coating agent, binder, and hardening ingredient. It helps give tablets and capsules their shape and protective outer layer.
-
UNII K49155WL9Y
Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
-
UNII 2ZA36H0S2V
Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.
5 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesCETEARYL ETHYLHEXANOATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, BEESWAX, MICROCRYSTALLINE WAX, TOCOPHERYL ACETATE (VITAMIN E ACETATE)
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 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 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
LabelerGalderma Laboratories, L.P.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code00299
First marketedMay 2021
Product typeHuman Otc Drug
Portfolio50 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 openFDA NDC Directory · synced Oct 1, 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
🧪 Active Ingredient
🧪 Inactive Ingredients
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses ● temporarily protects minor: ● cuts ● scrapes ● burns ● temporary protects and helps relieve chafed, chapped or cracked skin ● helps prevent and protect from the drying effects of wind and cold weather ● helps treat and prevent diaper rash ● protects chafed skin associated with diaper rash and helps protect from wetness
⏱️ Dosage and Administration ▾
Directions ● apply as needed ● for diaper rash, change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
⚠️ 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.
🧪 Active Ingredient ▾
Active ingredient......Purpose Petrolatum 71.5%......Skin Protectant
🧪 Inactive Ingredients ▾
Inactive Ingredients CETEARYL ETHYLHEXANOATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, BEESWAX, MICROCRYSTALLINE WAX, TOCOPHERYL ACETATE (VITAMIN E ACETATE)
📄 Questions or Comments ▾
Questions? 1-866-735-4137 Distributed By: Galderma Laboratories, L.P. Dallas, TX 75201 USA All trademarks are the property of their respective owners. Made in Canada cetaphil.com
📄 Package Label / Principal Display Panel ▾
PRINCIPLE DISPLAY PANEL - 12 OZ (340g) jar NEW LOOK Cetaphil ® Multi-Purpose Ointment HEALING 71.5% Petrolatum Skin Protectant All Skin Types Immediately protects to promote healing with a non-greasy finish Vitamin E Non-greasy feel NATIONAL ECZEMA ASSOCIATION LOGO NET WT 12 OZ (340 g) P56566-2
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 Cetaphil Healing (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 55%
Female · 45%
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 Galderma Laboratories, L.P.. 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 2 other package presentations of this same product, including 10 g (00299-4116-15), 85 g (00299-4116-00). 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?
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.
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.