ProCure Zinc Oxide 20 g/100g Ointment, 28.3 g
by Twin Med LLC · 28.3 g in 1 TUBE (55681-017-01)
NDC 55681-0017-01
🏷️ FDA NDC (as labeled)
55681-017-01
billing pads the product segment with a zero
This package
Contains28.3 g
Pack sizes3 compare ↓
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 →
⚠️
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
FDA NDC (as labeled)
55681-017-01
Product NDC
55681-017
11-digit billing NDC
55681001701
RxCUI
198911
UNII
SOI2LOH54Z
Application #
M016
SPL Set ID
37a30ee5-fd33-b410-e063-6294a90aef72
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2025-06-16
Route
TOPICAL
Dosage form
OINTMENT
Substance
ZINC OXIDE
Why two NDCs?
The FDA registers this code as 55681-017-01 — 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 → 55681-0017-01. 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
LabelerTwin Med LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code55681
First marketedJun 2025
Product typeHuman Otc Drug
Portfolio48 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?
ProCure Zinc Oxide is a topical ointment containing 20 percent zinc oxide, marketed as an over-the-counter monograph product. Zinc oxide is commonly used in skin-care products to create a protective barrier on the skin and is typically included in formulations intended to soothe and protect minor skin irritation. This ointment is applied directly to the skin surface.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Zinc oxide (OTC drug) — 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.
💬 Questions about Zinc Oxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
white
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 YRC528SWUY
A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
-
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 statesInactive ingredients: Ceteareth 20, Cetostearyl Alcohol, Light Mineral Oil, 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 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.
🔁 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/100gthis 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/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 | — |
| restorsea Rejuvenating Day SPF 30 Broad Spectrum UVA UVB with Vibransea Complex 20 g/100g 57670-0000-00 | RESTORSEA | 1 tube | — | — | FDA listed | — |
| SPF 50 Mineral Sunscreen 20 g/100g 72667-0101-01 | Inspec | 50 g | — | — | FDA listed | — |
| Radically Rejuvenating SPF Day Cream 20 g/100g 54136-0152-52 | Better | 52 g | — | — | FDA listed | — |
| Seriously Soothing SPF Day Cream 20 g/100g 54136-0179-52 | Better | 52 g | — | — | FDA listed | — |
| ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Stick Unscented SPF 30 20 g/100g 61649-0100-60 | 9055-7588 | 60 g | — | — | FDA listed | — |
| Attitude Kids Oatmeal sensitive mineral sunscreen unscented SPF 30 20 g/100g 61649-0162-75 | 9055-7588 | 75 g | — | — | FDA listed | — |
| Attitude Oatmeal sensitive mineral sunscreen unscented SPF 30 20 g/100g 61649-0165-15 | 9055-7588 | 150 g | — | — | FDA listed | — |
| Aloe UP SPF 33 Mineral 20 g/100g 61477-0231-01 | Aloe | 30 g | — | — | FDA listed | — |
| Attitude mineral sunscreen orange blossom SPF 30 20 g/100g 61649-0022-15 | 9055-7588 | 150 g | — | — | FDA listed | — |
| Attitude mineral sunscreen unscented SPF 30 20 g/100g 61649-0030-85 | Attitude | 85 g | — | — | Discontinued | — |
| Attitude mineral sunscreen tropical SPF 30 20 g/100g 61649-0031-85 | Attitude | 85 g | — | — | Discontinued | — |
| ATTITUDE Sunly Kids Mineral Sunscreen Stick Unscented SPF 30 20 g/100g 61649-0098-60 | 9055-7588 | 60 g | — | — | FDA listed | — |
| ATTITUDE Sunly Tinted Mineral Sunscreen Face Stick Unscented SPF 30 20 g/100g 61649-0097-20 | 9055-7588 | 20 g | — | — | FDA listed | — |
| All Good Mineral Sport Sunscreen Sunstick SPF 30 20 g/100g 75786-0220-01 | Elemental | 17 g | — | — | FDA listed | — |
| Mackenzies SPF 40 Ocean Safe Sunscreen 20 g/100g 80325-0040-02 | Naturally | 80 g | — | — | FDA listed | — |
| Zinctral 20 g/100g 59088-0627-05 | PureTek | 57 g | — | — | FDA listed | — |
| Aloe Up SPF 50 Mineral 20 g/100g 61477-0234-01 | Aloe | 89 g | — | — | FDA listed | — |
| Aloe Up SPF 50 Kids Mineral 20 g/100g 61477-0236-01 | Aloe | 89 g | — | — | FDA listed | — |
| Attitude mineral sunscreen tropical SPF 30 20 g/100g 61649-0021-15 | 9055-7588 | 150 g | — | — | FDA listed | — |
| ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Terracotta 20 g/100g 61649-0046-08 | 9055-7588 | 8.5 g | — | — | FDA listed | — |
| ATTITUDE Sunly Mineral Sunscreen Stick Unscented SPF 30 20 g/100g 61649-0090-60 | 9055-7588 | 60 g | — | — | FDA listed | — |
| ATTITUDE Sunly Mineral Sunscreen Stick Orange Blossom SPF 30 20 g/100g 61649-0092-60 | 9055-7588 | 60 g | — | — | FDA listed | — |
| Attitude Kids mineral sunscreen unscented SPF 30 20 g/100g 61649-0160-15 | 9055-7588 | 150 g | — | — | FDA listed | — |
| Mineral Defense Sport Ceramide Spf-30 20 g/100g 73054-0108-11 | SOLARA | 1 applicator | — | — | FDA listed | — |
| Attitude Kids mineral sunscreen unscented SPF 30 20 g/100g 61649-0038-85 | Attitude | 85 g | — | — | Discontinued | — |
| Attitude tinted mineral sunscreen face unscented SPF 30 20 g/100g 61649-0041-30 | Attitude | 30 g | — | — | Discontinued | — |
| ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Face Stick Unscented SPF 30 20 g/100g 61649-0101-20 | 9055-7588 | 20 g | — | — | FDA listed | — |
| All Good Coconut Mineral Sunscreen Sunstick SPF 30 20 g/100g 75786-0221-01 | Elemental | 17 g | — | — | FDA listed | — |
| ATTITUDE Sunly Mineral Sunscreen Face Stick Unscented SPF 30 20 g/100g 61649-0094-20 | 9055-7588 | 20 g | — | — | FDA listed | — |
| Medpride 20 g/100g 52410-3040-03 | Shield | 28 g | — | — | FDA listed | — |
| Medline 20 g/100g 53329-0220-07 | Medline | 14 g | — | — | FDA listed | — |
| ATTITUDE Sunly Mineral Sunscreen Stick Tropical SPF 30 20 g/100g 61649-0091-60 | 9055-7588 | 60 g | — | — | FDA listed | — |
| Bio Spectra Attitude 20 g/100g 61649-0120-01 | 9055-7588 | 75 g | — | — | FDA listed | — |
| BLDG Active Skin Repair Sun Stick Performance Sunscreen 20 g/100g 70489-1423-01 | Innovacyn, | 15 g | — | — | FDA listed | — |
| Stream2Sea SPF 50 20 g/100g 69555-0050-01 | Stream2Sea | 1 jar | — | — | FDA listed | — |
| Stream2Sea Sport Lip Balm SPF 50 20 g/100g 69555-0500-01 | Stream2Sea, | 4 g | — | — | FDA listed | — |
| ATTITUDE Sunly Kids Mineral Sunscreen Face Stick Unscented SPF 30 20 g/100g 61649-0099-20 | 9055-7588 | 20 g | — | — | FDA listed | — |
| Bio Spectra Attitude 20 g/100g 61649-0110-15 | 9055-7588 | 150 g | — | — | FDA listed | — |
| New Kid on the Block 20 g/100g 84568-0552-12 | Dimples | 106.8 g | — | — | FDA listed | — |
| Lasso Tallow Sunscreen Spf 50 20 g/100g 87761-0004-01 | Moes | 140 g | — | — | FDA listed | — |
| ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby Rose 20 g/100g 61649-0045-08 | 9055-7588 | 8.5 g | — | — | FDA listed | — |
| ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Peachy Shell 20 g/100g 61649-0047-08 | 9055-7588 | 8.5 g | — | — | FDA listed | — |
| Stream2Sea Reef Safer Mineral Sunscreen SPF40 20 g/100g 69555-0400-10 | Stream2Sea, | 1 jar | — | — | FDA listed | — |
| 365 Whole Foods Market Sport Mineral Spf 30 20 g/100g 42681-0062-01 | Whole | 44 g | — | — | FDA listed | — |
| Stream2Sea Ecostock SPF 40 Sunscreen 20 g/100g 69555-0401-01 | Stream2Sea, | 14 g | — | — | FDA listed | — |
| Utu Broad Spectrum SPF 30 Moisturizing Body Sunscreen 20 g/100g 87952-0004-02 | Utu | 1 bottle | — | — | 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
🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year 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 ProCure Zinc Oxide (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 37%
Female · 63%
Unknown · 0%
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 55681-0017-01 You're viewing this | 28.3 g in 1 TUBE (55681-017-01) | 2025-06-16 | Active |
| 55681-0017-02 | 56.6 g in 1 TUBE (55681-017-02) | 2025-06-16 | Active |
| 55681-0017-15 | 425 g in 1 JAR (55681-017-15) | 2025-06-16 | Active |
Pack size FAQ
What quantity is in NDC 55681-0017-01?
NDC 55681-0017-01 contains 28.3 g — 28.3 g in 1 tube.
What is the difference between NDC 55681-0017-01 and NDC 55681-0017-02?
Both are ProCure Zinc Oxide 20 g/100g Ointment — the drug itself is identical. NDC 55681-0017-01 is the 28.3 g package, while NDC 55681-0017-02 is the 56.6 g package.
What NDC number is used to bill for this package of ProCure Zinc Oxide 20 g/100g Ointment?
Bill NDC 55681-0017-01 — the 11-digit billing format is 55681001701. 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 55681-017-01, 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: 55681-0017-01, written without dashes as 55681001701. 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 55681-0017-01, the first segment (55681) is the labeler code FDA assigned to Twin Med LLC; the middle segment (0017) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Twin Med 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 2 other package presentations of this same product, including 56.6 g (55681-0017-02), 425 g (55681-0017-15). 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?
Twin Med 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.
📄 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 ▾
Uses helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness dries the ozzing and weeping of poison ivy, poison oak and posion sumac
⏱️ Dosage and Administration ▾
Directions Directions: For Diaper Rash: change wet and soiled diapers promptly cleanse the siaper area and allow to dry apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or when exposure to wet diapers may be prolonged For poison ivy, oak and suman: apply as needed
⚠️ Warnings ▾
Warnings Warnings For external use only. When using this product When using this product do not get into eyes Stop use and ask a doctor if 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
🧪 Active Ingredient ▾
Active Ingredient Zinc Oxide
🧪 Inactive Ingredients ▾
Inactive ingredients Inactive ingredients: Ceteareth 20, Cetostearyl Alcohol, Light Mineral Oil, Petrolatum
🎯 Purpose ▾
Purpose Skin Protectant
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 ↗
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.