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Barrier Cream ZINC OXIDE 100 mg/100mL Cream, 59 mL — NDC 58518-040-02 (Billing 58518-0040-02)

by Avasol LLC · 59 mL in 1 POUCH

This is a package of 59 mL of Barrier Cream ZINC OXIDE 100 mg/100mL Cream from Avasol LLC, marketed since Jan 2022 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 58518-0040-02
🏷️ FDA NDC (as labeled) 58518-040-02 billing pads the product segment with a zero
This package
Contains59 mL Pack sizes2 compare ↓
Main listing for product 58518-040 · Also comes in: 28 ml 58518-040-03
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 58518-040-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
58518 labeler · 040 product · 02 package
Package marketed since
Jan 1, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5851804002 6
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Zinc Oxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0212-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0206-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0202-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0207-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0209-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0208-2026
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) 58518-040-02
Product NDC 58518-040
11-digit billing NDC 58518004002
UNII SOI2LOH54Z
Application # M016
SPL Set ID bc6a2736-faa6-46d3-af9b-a70f0762e9ce
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-01-01
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 58518-040-02 — 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 → 58518-0040-02. 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?

Barrier Cream Zinc Oxide is a topical cream containing zinc oxide, an over-the-counter monograph product marketed under FDA's established rules for this category. Zinc oxide is commonly used in barrier and protective creams to help shield skin from moisture and irritants. This type of product is typically applied to the skin to help protect against diaper rash, minor skin irritation, and chafing.

Supplement & herbal interactions

Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Zinc oxide (OTC drug) (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.
Try another pack size: 28 ml
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
58518-0040-02 You're viewing this Main listing 59 mL in 1 POUCH 2022-01-01 — Active
58518-0040-03 58518-040-03 28 mL in 1 TUBE 2022-01-01 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 59 mL — 59 ml in 1 pouch.
How does this package differ from NDC 58518-0040-03?
Both are Barrier Cream ZINC OXIDE 100 mg/100mL Cream — the drug itself is identical. This page's package is the 59 mL one, while NDC 58518-0040-03 is the 28 ml package.
What NDC number is used to bill for this package of Barrier Cream ZINC OXIDE 100 mg/100mL Cream?
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
Barrier Cream 100 mg/100mLthis 58518-0040-02 Avasol 59 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

🏛️
2022
On the market since
Jan 2022
📍
2026
Currently FDA-listed
4 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

LabelerAvasol LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code58518
First marketedJan 2022
Product typeHuman Otc Drug
Portfolio4 products on file

More NDCs from Avasol LLC labeler code 58518

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 🎯 Purpose 📄 Do Not Use 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 35 words ▾

Uses Temporarily protects the skin and prevents chafing, blisters and irritation and helps seal out wetness. Helps prevent and helps relieve minor skin irritation and itching due to rashes, chafed, chapped, cracked, or windburned skin.

⏱️ Dosage and Administration 16 words ▾

Directions Apply liberally, directly on skin as needed. Safe to apply to prosthetics, protective equipment, etc.

⚠️ Warnings 80 words ▾

Warnings For external use only Avoid contact with eyes. Rinse with water to remove. Stop use and ask a doctor Condition worsens symptoms last for more than 7 days or clear up and occur again within a few days Do not use: if allergic to ingredients. on deep or puncture wounds on animal bites •on serious burns. Test small area first. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 6 words ▾

Active Ingredients Zinc Oxide (Non-nano) 10%

🧪 Inactive Ingredients 75 words ▾

Inactive ingredients *Caprylic/Capric Triglyceride (Fractionated Coconut Oil), *Cocos Nucifera (Coconut) Oil, *Cera Alba (beeswax), **Euphorbia Cerifera (candelilla) wax, *Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol, Olea Europaea (Olive) Leaf Extract, Citrus Aurantium Dulcis Peel Cera, Astaxanthin, Bentonite, Cetearyl Olivate, Sorbitan Olivate, *Propolis, *Lavandula Angustifolia (Lavender) Oil, *Rosmarinus Officinalis (Rosemary) Leaf Extract,*Aloe barbadensis,*St. John's wort (Hypericum perforatum),*Chamomile (Matricaria chamomilla L), *Licorice Root (Glycyrrhiza glabra), *Calendula Officinalis Flower Extract, **Leptospermum scoparium (Manuka) Oil, *Mentha Piperita (Peppermint) Oil *Organic

🎯 Purpose 3 words ▾

Purpose Skin protectant

📄 Do Not Use 22 words ▾

Do not use: if allergic to ingredients. on deep or puncture wounds on animal bites •on serious burns. Test small area first.

📄 Stop Use and Ask a Doctor If 25 words ▾

Stop use and ask a doctor Condition worsens symptoms last for more than 7 days or clear up and occur again within a few days

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Other Information 19 words ▾

Other information store product between 45 to 100F Gently warm or knead product as needed to soften before use.

📄 Questions or Comments 6 words ▾

Questions? Call 888-805-1507 or visit www.avasol.com

📄 Package Label / Principal Display Panel 3 words ▾

Avasol Barrier Cream

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 Barrier Cream (this brand).

Top reported reactions

Macular Degeneration460
Pyrexia308
Nausea293
Pain282
Malaise261
Weight Decreased239
Therapeutic Product Effect Incomplete214

Age at onset

Neonate5
Infant8
Child28
Adolescent5
Adult110
Elderly192

Reporter sex

1,953 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization995
Death207
Life-threatening117
Disabling33
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 273 83
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 — Not published for this NDC No photo available yet for this listing.
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 Avasol 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 28 ml (58518-0040-03). 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?
Avasol 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.
← 58518-0021-01 · Avasol 58544-0150-02 · Hankook →
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.