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zinc oxide 20% 20 g/100g Ointment, 425 g

by Bionpharma Inc · 425 g in 1 JAR (69452-450-58)
NDC 69452-0450-58
🏷️ FDA NDC (as labeled) 69452-450-58 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ 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

🆔 Identity & classification

FDA NDC (as labeled) 69452-450-58
Product NDC 69452-450
11-digit billing NDC 69452045058
RxCUI 198911
UNII SOI2LOH54Z
Application # M016
SPL Set ID 1549500a-0941-0fba-e063-6394a90a564e
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-04-01
Route TOPICAL
Dosage form OINTMENT
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 69452-450-58 — 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 → 69452-0450-58. 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

LabelerBionpharma Inc
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code69452
First marketedApr 2024
Product typeHuman Otc Drug
Portfolio2 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.

🩺 Clinical

🧪 What is this product?

This is an over-the-counter topical ointment containing 20% zinc oxide. Zinc oxide is commonly used in skin-care products as a protective barrier and is typically applied to the skin to help shield it from moisture and irritants. This product is marketed under the FDA's OTC monograph rules for its category, meaning it follows established standards for nonprescription use rather than individual FDA approval.

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 I835H2IHHX
    A waxy substance derived from plant oils, used as an emulsifier and solubilizer to help mix oil and water ingredients together and keep them blended throughout the product's shelf life.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII N6K5787QVP
    Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
  • UNII B6E5W8RQJ4
    White petrolatum is a purified mineral oil product used as a lubricant and skin protectant in medications. It helps pills slide through manufacturing equipment and can soften or protect the skin when applied topically.

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

The official label also statesceteareth 20, cetostearyl alcohol, light mineral oil, white petrolatum

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
Zinc Oxide 20 g/100g 68001-0533-50 BluePoint 454 g $0.015 — Availability likely —
Leader Zinc Oxide 200 mg/g 70000-0334-01 Cardinal 454 g $0.015 — Availability likely —
Good Neighbor Pharmacy Skin Protectant .2 g/g 46122-0676-46 AMERISOURCE 1 tube $0.036 — Availability likely —
Rugby Zinc Oxide 20% 20 g/100g 00536-1316-25 Rugby 72 tubes $0.061 — Availability likely —
Zinc Oxide 20 g/100g 68001-0532-45 BluePoint 1 tube $0.077 — Availability likely —
Nivagen Zinc Oxide 200 mg/g 75834-0170-01 Nivagen 28.4 g $0.105 — Availability likely —
Sheffield Zinc Oxide 200 mg/g 11527-0065-34 Sheffield 1 tube — — FDA listed —
CAREALL Zinc Oxide .2 g/g 51824-0032-03 New 28 g — — FDA listed —
ProCure Zinc Oxide 20 g/100g 55681-0017-01 Twin 28.3 g — — FDA listed —
Procure 20 g/100g 55681-0304-03 TWIN 28.3 g — — FDA listed —
Endit Zinc Oxide Skin Protectant 20 g/100g 64068-0402-01 Endit 454 g — — FDA listed —
Endit zinc oxide skin protection 200 mg/g 64068-0500-01 EndIt 56.7 g — — FDA listed —
Zinc Oxide .2 g/g 64772-0201-01 Derma 453.6 g — — FDA listed —
Zinc Oxide 200 mg/g 67777-0223-02 Dynarex 1 tube — — FDA listed —
Zinc Oxide 20% .2 g/g 68016-0159-02 Pharmacy 1 tube — — FDA listed —
dabur 20 g/100g 68747-3040-03 Dabur 28 g — — FDA listed —
Zinc Oxide 20% .2 g/g 69396-0021-02 Trifecta 1 tube — — FDA listed —
Zinc Oxide 20% .2 g/g 69396-0086-02 Trifecta 1 tube — — FDA listed —
zinc oxide 20% 20 g/100gthis 69452-0450-58 Bionpharma 425 g — — FDA listed —
Zinc Oxide 20 g/100g 69771-0109-38 Geri-Gentle 1 tube — — FDA listed —
CVS Zinc Oxide 200 mg/g 69842-0065-34 CVS 1 tube — — FDA listed —
Medpura Zinc Oxide 20% 20 g/100g 71399-0245-02 Akron 1 tube — — FDA listed —
Zinc Oxide 20% .2 g/g 83324-0052-01 Chain 1 tube — — FDA listed —
Zinc Oxide Pharma 200 mg/g 84387-0001-01 ALLIED 56.6 g — — FDA listed —
ElixirZincoCare 20 g/100g 84546-0004-01 ELIXIR 1 tube — — FDA listed —
Zinc Oxide Skin Protectant 20 g/100g 87236-0007-16 Aldermed 454 g — — FDA listed —
Mineral Sunscreen 20 g/100g 84380-0001-90 The 90 g — — FDA listed —
Coppertone Sunscreen SPF 50 20 g/100g 66800-4115-00 Beiersdorf 1 cylinder — — 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

🏛️
2024
On the market since
Apr 2024
📍
2026
Currently FDA-listed
2 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
69452-0450-58 You're viewing this 425 g in 1 JAR (69452-450-58) 2024-04-18 Active

🧭 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) ✓ 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 FDA registers it as 69452-450-58, 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: 69452-0450-58, written without dashes as 69452045058. 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 69452-0450-58, the first segment (69452) is the labeler code FDA assigned to Bionpharma Inc; the middle segment (0450) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (58) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Bionpharma Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bionpharma 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 35 words ▾

Uses ■ Dries the oozing and weeping of poison • ivy • oak • sumac ■ Helps treat and prevent diaper rash ■ Protects chafed skin due to diaper rash and helps seal out wetness

⏱️ Dosage and Administration 54 words ▾

Directions ■ For poison ivy, oak & sumac: 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 bed time or anytime when exposure to wet diapers may be prolonged

⚠️ Warnings 5 words ▾

Warnings For external use only

📦 Storage and Handling 11 words ▾

Other information ■ Store at 15°C – 30°C (59°F – 86°F)

🧪 Active Ingredient 6 words ▾

Active ingredient Zinc Oxide 20 %

🧪 Inactive Ingredients 11 words ▾

Inactive ingredients ceteareth 20, cetostearyl alcohol, light mineral oil, white petrolatum

🎯 Purpose 3 words ▾

Purpose Skin Protectant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 69452-0449-37 · Bionpharma 69452-0451-22 · BIONPHARMA →
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.