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Manzatin Diaper Rash Skin Protectant ZINC OXIDE 180 mg/g Ointment, 235 g — NDC 55715-0005-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Manzatin Diaper Rash Skin Protectant ZINC OXIDE 180 mg/g Ointment, 235 g — NDC 55715-005-05 (Billing 55715-0005-05)

by Laboratorios Zepol S.A. · 235 g in 1 BOTTLE

This is a package of 235 g of Manzatin Diaper Rash Skin Protectant ZINC OXIDE 180 mg/g Ointment from Laboratorios Zepol S.A., marketed since Nov 2021 and currently FDA-listed.

NDC 55715-0005-05
🏷️ FDA NDC (as labeled) 55715-005-05 billing pads the product segment with a zero
This package
Contains235 g Pack sizes5 compare ↓
Product page 55715-0005-01 Also comes in: 90 g 55715-005-01 130 g 55715-005-02 170 g 55715-005-03 180 g 55715-005-04
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 55715-005-05 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
55715 labeler · 005 product · 05 package
Package marketed since
Nov 1, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0735549310012, 0735549310036
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) 55715-005-05
Product NDC 55715-005
11-digit billing NDC 55715000505
RxCUI 1039181
UNII SOI2LOH54Z
UPC 0735549310012, 0735549310036
Application # M016
SPL Set ID 5c1618a4-ca08-4814-a556-74e79db618b9
Established class (EPC) Copper Absorption Inhibitor
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-11-01
Route TOPICAL
Dosage form OINTMENT
Substance ZINC OXIDE
Quick answers
  • RxCUI (RxNorm): 1039181
Why two NDCs? The FDA registers this code as 55715-005-05 — 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 → 55715-0005-05. 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?

Manzatin Diaper Rash Skin Protectant is an over-the-counter ointment that contains zinc oxide, a mineral commonly used in skin protectant products. Applied topically to the skin, zinc oxide functions as a physical barrier and is typically used to help protect against moisture and irritants in diaper rash formulations. This product is marketed under FDA's over-the-counter monograph rules for skin protectants.

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: 90 g 130 g 170 g 180 g
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
55715-0005-01 55715-005-01 Main listing 90 g in 1 TUBE 2021-11-01 — Active
55715-0005-02 55715-005-02 130 g in 1 BOTTLE 2021-11-01 — Active
55715-0005-03 55715-005-03 170 g in 1 TUBE 2021-11-01 — Active
55715-0005-04 55715-005-04 180 g in 1 TUBE 2021-11-01 — Active
55715-0005-05 You're viewing this 235 g in 1 BOTTLE 2021-11-01 — Active

You're viewing the largest of 5 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 235 g — 235 g in 1 bottle.
How does this package differ from NDC 55715-0005-01?
Both are Manzatin Diaper Rash Skin Protectant ZINC OXIDE 180 mg/g Ointment — the drug itself is identical. This page's package is the 235 g one, while NDC 55715-0005-01 is the 90 g package.
What NDC number is used to bill for this package of Manzatin Diaper Rash Skin Protectant ZINC OXIDE 180 mg/g Ointment?
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
Manzatin-E Diaper Rash Skin Protectant 18 g/100g 55715-0002-02 Laboratorios 90 g — — FDA listed —
Manzatin Diaper Rash Skin Protectant 180 mg/gthis 55715-0005-05 Laboratorios 235 g — — FDA listed —
PROTEKT SPF-50 Sheer Mineral Sunscreen 180 mg/g 82912-0323-00 Protekt 170 g — — FDA listed —
Re Screen Broad Spectrum Spf 30 Sunscreen 180 mg/g 87608-0001-02 Zouck 1 g — — FDA listed —
Sunny Sailor First Mate Face Stick SPF 30 180 mg/g 85135-0896-00 SUNNY 1 applicator — — 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

🏛️
2021
On the market since
Nov 2021
📍
2026
Currently FDA-listed
5 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII O2T154T6OG
    A natural plant extract from chamomile flowers. It's used as a flavoring and fragrance ingredient in medicines to improve taste or aroma.
  • UNII BBL281NWFG
    Cod liver oil is a natural oil derived from fish liver that serves as a source of omega-3 fatty acids and vitamins A and D in formulations. It's used as a nutrient supplement ingredient and as an emollient to help soften and smooth the product.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

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

The official label also statesChamomile flower extract, Cod liver oil, in special protective lipod cream base, Corn starch.

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.

Manufacturer & labeler

LabelerLaboratorios Zepol S.A.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code55715
First marketedNov 2021
Product typeHuman Otc Drug
Portfolio7 products on file

More NDCs from Laboratorios Zepol S.A. labeler code 55715

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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 18 words ▾

Uses: Helps treat and prevent diaperash. Protects chafed skin due to diaper rash and helps seal out wetness.

⏱️ Dosage and Administration 41 words ▾

Directions: Change wet and soiled diapers promptly, cleanese the diaper area and allow to dry. Apply the cream liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.

⚠️ Warnings 56 words ▾

Warnings: For external use only. When using this product do not get into eyes. Stop use and ask a doctor if condition worsens. symptoms last more than 7days or clear up and occur again within a few days. Keep out of reach of children. If swallowed, get mediccal help or contact Poison Control Center right away.

🧪 Active Ingredient 8 words ▾

Active Ingredients Zinc Oxide 18% Purpose Skin protectant

🧪 Inactive Ingredients 16 words ▾

Inactive ingredients: Chamomile flower extract, Cod liver oil, in special protective lipod cream base, Corn starch.

🎯 Purpose 3 words ▾

Purpose Skin protectant

📄 When Using This Product 9 words ▾

When using this product do not get into eyes.

📄 Stop Use and Ask a Doctor If 24 words ▾

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

📄 Keep Out of Reach of Children 18 words ▾

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

📄 Package Label / Principal Display Panel 10 words ▾

55715-005-01 Label

55715-005-02 Label2

55715-005-03 Label3

55715-005-04 Label4

55715-005-05 Label5

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 ZINC OXIDE — the ingredient across all brands.

Top reported reactions

Macular Degeneration460
Nausea365
Pyrexia351
Pain348
Malaise289
Weight Decreased284
Constipation257

Age at onset

Neonate6
Infant11
Child35
Adolescent8
Adult218
Elderly272

Reporter sex

3,195 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization1,367
Life-threatening166
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 365 0
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 ✓ 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 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 Laboratorios Zepol S.A.. 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 4 other package presentations of this same product, including 90 g (55715-0005-01), 130 g (55715-0005-02), 170 g (55715-0005-03). 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?
Laboratorios Zepol S.A. 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.
← 55715-0004-01 · Laboratorios 55715-0006-01 · Laboratorios →
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.