NDC 67777-0223-02 — Zinc Oxide 200 mg/g Ointment

🆔 Identity & classification

FDA NDC (as labeled) 67777-223-02

Product NDC 67777-223

11-digit billing NDC 67777022302

NCPDP billing unit GM — per gram (weight)

RxCUI 198911

UNII SOI2LOH54Z

UPC 0616784119113, 0616784119014, 0616784119212

Application # M016

SPL Set ID 11d79dd6-35f7-4399-e063-6294a90ac7dd

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2024-02-29

Route TOPICAL

Dosage form OINTMENT

Substance ZINC OXIDE

GCN Seq No 005576

GCN 22080

HICL code 002361

Ingredient (HICL) Zinc Oxide

HIC1 code L

Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue

HIC2 code L3

Therapeutic class — intermediate (HIC2) Protectives

HIC3 code L3A

Therapeutic class — specific (HIC3) Protectives

AHFS code 84:24.12.00

AHFS class Basic Ointments And Protectants

FDB label name ZINC OXIDE 20% OINTMENT

FDB brand name Zinc Oxide

Legend status O — Over-the-counter (OTC) drug or device

Why two NDCs? The FDA registers this code as 67777-223-02 — 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 → 67777-0223-02. 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

LabelerDynarex Corporation

FDA applicationM016 (OTC MONOGRAPH DRUG)

Labeler code67777

First marketedFeb 2024

Product typeHuman Otc Drug

Portfolio60 products on file

🔎 All NDCs from Dynarex Corporation

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

Label name ZINC OXIDE 20% OINTMENT Ingredient Zinc Oxide

🧪 What is this product?

This is an over-the-counter topical ointment containing zinc oxide, marketed under FDA's OTC monograph rules for skin-care products. Zinc oxide is commonly used in ointments and creams to function as a skin protectant and mild astringent. It is typically applied to the skin to help protect minor cuts, scrapes, and irritated areas, and is a frequent ingredient in diaper rash and wound-care products. The high concentration (200 mg per gram) makes this formulation suitable for localized skin applications.

Patient education

📘 MedlinePlus patient leaflet ↗

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.

💊 What it looks like

ShapeFreeform

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 statesCetomacrogol 1000. Cetostearyl Alcohol Light Liquid Paraffin, White Soft Paraffin

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 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

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: 56.7 g 12 jars

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Zinc Oxide 20 g/100g 68001-0533-50	BluePoint	454 g	$0.016	—	Availability likely	—
Leader Zinc Oxide 200 mg/g 70000-0334-01	Cardinal	454 g	$0.016	—	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	$0.059	—	Availability likely	—
Zinc Oxide 20 g/100g 68001-0532-45	BluePoint	1 tube	$0.079	—	Availability likely	—
Nivagen Zinc Oxide 200 mg/g 75834-0170-01	Nivagen	28.4 g	$0.107	—	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/gthis 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/100g 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	—

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

Feb 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.

🔬 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 Skin Protectant — the ingredient across all brands.

Top reported reactions

Macular Degeneration462

Pyrexia396

Nausea360

Malaise315

Pain314

Weight Decreased267

Diarrhoea245

Age at onset

Neonate5

Infant10

Child36

Adolescent12

Adult200

Elderly303

Reporter sex

Male · 42%

Female · 58%

Unknown · 0%

Serious outcomes

Hospitalization1,740

Death442

Life-threatening239

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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
67777-0223-02 You're viewing this	72 BOX in 1 CASE (67777-223-02) / 1 TUBE in 1 BOX (67777-223-11) / 28.4 g in 1 TUBE (67777-223-01)	2024-02-29	Active
67777-0223-04	72 BOX in 1 CASE (67777-223-04) / 1 TUBE in 1 BOX (67777-223-13) / 56.7 g in 1 TUBE (67777-223-03)	2024-02-29	Active
67777-0223-06	12 JAR in 1 CASE (67777-223-06) / 425 g in 1 JAR (67777-223-05)	2024-02-29	Active

Pack size FAQ

What quantity is in NDC 67777-0223-02?

NDC 67777-0223-02 is listed by the FDA — 72 box in 1 case / 1 tube in 1 box / 28.4 g in 1 tube.

What NDC number is used to bill for this package of Zinc Oxide 200 mg/g Ointment?

Bill NDC 67777-0223-02 — the 11-digit billing format is 67777022302. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 67777-223-02, 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: 67777-0223-02, written without dashes as 67777022302. 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 67777-0223-02, the first segment (67777) is the labeler code FDA assigned to Dynarex Corporation; the middle segment (0223) 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.

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 Dynarex Corporation. 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 1 tube (67777-0223-04), 12 jars (67777-0223-06). 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?

Dynarex Corporation 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 22 words ▾

Use(s) • Helps treat chafed skin associated with diaper rash • Dries the oozing and weeping of poison ivy, oak, and sumac

⏱️ Dosage and Administration 53 words ▾

Directions • 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. • For poison ivy, oak, and sumac: Apply as needed.

⚠️ Warnings 61 words ▾

Warnings For External Use Only When using this product • Avoid contact with 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 Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

🧪 Active Ingredient 5 words ▾

Active Ingredient Zinc Oxide 20%

🧪 Inactive Ingredients 12 words ▾

Inactive Ingredients Cetomacrogol 1000. Cetostearyl Alcohol Light Liquid Paraffin, White Soft Paraffin

🎯 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 ↗

🔗 Related NDC lookups

🧪 All Zinc Oxide Ointment NDCsSame ingredient 🏭 All Dynarex labeler NDCsLabeler code 67777

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Protectives.

Dimethicone 00093-3204-14 Calamine/Zinc Oxide 00363-0224-30 Menthol/Zinc Oxide 00363-3680-04 Calamine/Phenol Liquid 00395-0407-96 Petrolatum,White 00536-1143-97 Benzoin Compound 46414-8888-02 Benzoin 49348-0138-30 Glycerin 67777-0161-10 Zinc Oxide/Cod Liver Oil 69968-0061-01

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.