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Barrier Balm Skin Protectant 15 g/100g Ointment, 57 g — NDC 75523-0200-02 package photo

Barrier Balm Skin Protectant 15 g/100g Ointment, 57 g

by PROJECT CHEMISTRY, INC. · 57 g in 1 TUBE (75523-200-02)
NDC 75523-0200-02
🏷️ FDA NDC (as labeled) 75523-200-02 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ Data synced 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

⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 75523-200-02
Product NDC 75523-200
11-digit billing NDC 75523020002
RxCUI 245663
UNII SOI2LOH54Z
Application # M016
SPL Set ID ea608b09-a043-7457-e053-2995a90a48af
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2022-10-19
Route TOPICAL
Dosage form OINTMENT
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 75523-200-02 — 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 → 75523-0200-02. 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.

🏭 Manufacturer & labeler

LabelerPROJECT CHEMISTRY, INC.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code75523
First marketedOct 2022
Product typeHuman Otc Drug
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.

🩺 Clinical

🧪 What is this product?

Barrier Balm Skin Protectant is an over-the-counter topical ointment that contains zinc oxide as its active ingredient. This product is marketed under the FDA's OTC monograph rules for skin protectant drugs. Zinc oxide is commonly used in barrier ointments to help protect and soothe minor skin irritation, such as diaper rash or chafing, by forming a protective layer on the skin surface.

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.

🧪 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 PKO39VY215
    A natural compound derived from Centella asiatica plant, used as an active botanical extract or skin-conditioning agent in topical formulations to support ingredient stability and product efficacy.
  • UNII J3N6X3YK96
    C15-23 alkane is a colorless, odorless oil made from petroleum hydrocarbons. In medicines, it serves as a lubricant and glidant to help tablets and capsules flow smoothly during manufacturing and prevent sticking.
  • UNII 6810070TYD
    Centella asiatica leaf is a plant extract used in medicines as a skin-conditioning agent and natural ingredient. It may help soften or soothe the product's texture and is included for its traditional botanical properties in topical or oral formulations.
  • UNII 8D9H4QU99H
    A synthetic fatty acid ester derived from coconut oil, used as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the body absorbs certain drugs.
  • UNII 1E5KJY107T
    A liquid mixture derived from coconut oil, coconut alkanes serve as a solvent and lubricant in medicines. They help dissolve active ingredients and reduce friction during manufacturing and tablet compression.
  • UNII T53SBG6741
    A plant-based oil extracted from sea buckthorn seeds. It's used as an emollient and skin-conditioning agent to soften the medicine's texture and improve how it feels or spreads on skin.
  • UNII A2M91M918C
    A plant-based oil derived from soybeans that has been chemically hardened to make it solid or semi-solid at room temperature. It acts as a binder, filler, and lubricant to help hold the tablet together and allow it to move smoothly during manufacturing and packaging.
  • UNII CQ2F5O6YIY
    A natural compound extracted from Centella asiatica plant used as an active skin-conditioning ingredient. It functions as a humectant and skin protectant to improve moisture retention and support skin barrier function in topical formulations.
  • UNII L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • UNII REM6A5QMC0
    A plant-based oil extracted from moringa tree seeds. It's used in medicines as an emollient to soften and smooth the product, and sometimes as a natural carrier or conditioning agent in formulations.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.

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

The official label also statesInactive Ingredients Hydrogenated Soybean Oil, Coconut Alkanes, Silica, Hydrogenated Soy Polyglycerides, C15-23 Alkane, Madecassoside, Asiaticoside, Centella Asiatica Leaf Extract, Hippophae Rhamnoides Seed Oil, Moringa Oleifera Seed Oil, Coco-Caprylate, Tocopheryl Acetate, Menthol.

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.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Barrier Balm 15 g/100gthis 75523-0200-02 PROJECT 57 g — — Discontinued —
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
Oct 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
75523-0200-02 You're viewing this 57 g in 1 TUBE (75523-200-02) 2022-10-19 Inactivated by FDA

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 FDA registers it as 75523-200-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 75523-0200-02, written without dashes as 75523020002. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 75523-0200-02, the first segment (75523) is the labeler code FDA assigned to PROJECT CHEMISTRY, INC.; the middle segment (0200) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
PROJECT CHEMISTRY, INC. 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.

📄 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
🎯 Indications and Usage 9 words ▾

To help prevent and relieve skin irritation from wetness.

⏱️ Dosage and Administration 11 words ▾

Directions: Apply a thin layer as needed to clean, dry skin.

⚠️ Warnings 5 words ▾

Warnings: For external use only.

🧪 Active Ingredient 3 words ▾

Zinc Oxide 15%

🧪 Inactive Ingredients 31 words ▾

Inactive Ingredients Hydrogenated Soybean Oil, Coconut Alkanes, Silica, Hydrogenated Soy Polyglycerides, C15-23 Alkane, Madecassoside, Asiaticoside, Centella Asiatica Leaf Extract, Hippophae Rhamnoides Seed Oil, Moringa Oleifera Seed Oil, Coco-Caprylate, Tocopheryl Acetate, Menthol.

🎯 Purpose 2 words ▾

Skin Protectant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 75470-0303-01 · Tecnoglobal, 75541-0016-01 · NINGBO →
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.