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Secura Extra Protective Cream ZINC OXIDE 306.1 mg/g Cream, 219 g — NDC 69740-0325-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Secura Extra Protective Cream ZINC OXIDE 306.1 mg/g Cream, 219 g — NDC 69740-325-00 (Billing 69740-0325-00)

by Smith & Nephew Medical Ltd · 219 g in 1 TUBE

This is a package of 219 g of Secura Extra Protective Cream ZINC OXIDE 306.1 mg/g Cream from Smith & Nephew Medical Ltd, marketed since Aug 2003 and currently FDA-listed. It is this product's only package size.

NDC 69740-0325-00
🏷️ FDA NDC (as labeled) 69740-325-00 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 69740-325-00 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69740 labeler · 325 product · 00 package
Package marketed since
Aug 1, 2003
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6974032500 3
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) 69740-325-00
Product NDC 69740-325
11-digit billing NDC 69740032500
RxCUI 477180
UNII SOI2LOH54Z
Application # M016
SPL Set ID 499a1944-1682-4798-9058-3748a5eaa420
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2003-08-01
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 053971
GCN 21759
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 SECURA EXTRA PROTECTIVE CREAM
FDB brand name Secura Extra Protective
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 053971
  • GCN: 21759
  • HICL (First Databank): 002361
  • AHFS class code: 84:24.12.00
  • RxCUI (RxNorm): 477180
Why two NDCs? The FDA registers this code as 69740-325-00 — 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 → 69740-0325-00. 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

Label name SECURA EXTRA PROTECTIVE CREAM Ingredient Zinc Oxide
🧪 What is this product?

Secura Extra Protective Cream is a topical cream containing zinc oxide, an over-the-counter monograph product. Zinc oxide is commonly used in protective creams to form a barrier on the skin. This ingredient is typically applied to areas prone to moisture or friction, such as diaper rash zones or skin folds, to help reduce irritation.

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.
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
69740-0325-00 You're viewing this Main listing 219 g in 1 TUBE 2003-08-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Secura Extra Protective 306.1 mg/g 69740-0324-00 Smith 92 g — — FDA listed —
Secura Extra Protective Cream 306.1 mg/gthis 69740-0325-00 Smith 219 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

🏛️
2003
On the market since
Aug 2003
📍
2026
Currently FDA-listed
23 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 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 PH41D05744
    A synthetic antimicrobial chemical compound used as a preservative in medicines and personal care products. It prevents bacterial and fungal growth to keep the product safe during storage and use.
  • UNII 3QPI1U3FV8
    A preservative derived from benzoic acid that prevents bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • 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 H5RIZ3MPW4
    A chemical preservative used to prevent bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII 73W9IQY50Q
    Karaya gum is a natural thickening agent derived from an Asian tree. It acts as a binder and stabilizer in medicines, helping create proper texture and consistency while preventing separation of ingredients.
  • UNII FA9KFJ4Z6P
    A manufactured compound combining glucose (a natural sugar) with oleic acid (a fatty acid). It acts as an emulsifier and solubilizer, helping mix oil and water-based ingredients together in the medicine.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesbenzethonium chloride, butylparaben, cellulose gum, cetearyl alcohol, diazolidinyl urea, methyl glucose dioleate, methylparaben, mineral oil, petrolatum, tocopheryl acetate, water, xanthan gum.

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

LabelerSmith & Nephew Medical Ltd
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code69740
First marketedAug 2003
Product typeHuman Otc Drug
Portfolio10 products on file

More NDCs from Smith & Nephew Medical Ltd labeler code 69740

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 37 words ▾

USES skin protectant helps treat and prevent diaper rash protects minor skin irritation associated with diaper rash and helps seal out wetness Update in line with OTC Monograph Amendment from reference to 'dermatitis' to 'rash' Apr 2025

⏱️ Dosage and Administration 47 words ▾

DIRECTIONS change wet and soiled diapers, garments and linens promptly cleanse the affected area and allow to dry apply cream liberally as often as necessary with each diaper change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged

⚠️ Warnings 101 words ▾

WARNINGS For external use only Stop use and ask a doctor if condition worsens , symptoms last more than 7 days or clears up and occur again within a few days When using this product do not get into eyes Not to be applied over deep or puncture wounds, infections, or lacerations Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Certer immediately If condition worsens or does not improve within 7 days, contact a doctor Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

📦 Storage and Handling 17 words ▾

OTHER INFORMATION Store at controlled room temperature 59 o F-86 o F (15 o C-30 o C)

🧪 Active Ingredient 5 words ▾

ACTIVE INGREDIENT Zinc Oxide 30.6%

🧪 Inactive Ingredients 23 words ▾

INACTIVE INGREDIENTS benzethonium chloride, butylparaben, cellulose gum, cetearyl alcohol, diazolidinyl urea, methyl glucose dioleate, methylparaben, mineral oil, petrolatum, tocopheryl acetate, water, xanthan gum.

🎯 Purpose 3 words ▾

PURPOSE Skin protectant

📄 Stop Use and Ask a Doctor If 13 words ▾

If condition worsens or does not improve within 7 days, contact a doctor

📄 Keep Out of Reach of Children 18 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

📄 Questions or Comments 6 words ▾

QUESTIONS OR COMMENTS? 1 800 876-1261

📄 Recent Major Changes 15 words ▾

Update in line with OTC Monograph Amendment from reference to 'dermatitis' to 'rash' Apr 2025

📄 Package Label / Principal Display Panel 165 words ▾

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - TUBE (92g) Item #59432400 NDC 69740-324-00 Extra Protective Cream Skin Protectant For treatment and prevention of incontinence-associated dermatitis For use on denuded skin associated with exposure to feces or urine Adheres to macerated skin Pediatric tested CHG compatible Smith & Nephew Secura ◊ Extra Protective Cream Made in India for Smith & Nephew Medical Ltd, 101 Hessle Road, Hull, HU3 2BN, England ◊ Trademark of Smith & Nephew Certain marks reg'd U.S. Pat. and Tm. Off.

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- TUBE (219g) Item #59432500 NDC 69740-325-00 Extra Protective Cream Skin Protectant For treatment and prevention of incontinence-associated dermatitis For use on denuded skin associated with exposure to feces or urine Adheres to macerated skin Pediatric tested CHG compatible Smith & Nephew Secura◊ Extra Protective Cream Made in India for Smith & Nephew Medical Ltd, 101 Hessle Road, Hull, HU3 2BN, England ◊Trademark of Smith & Nephew Certain marks reg'd U.S. Pat. and Tm. Off.

69740-324-00 219grams-secura-label

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 Secura Extra Protective Cream (this brand).

Top reported reactions

Macular Degeneration460
Pyrexia306
Nausea290
Pain282
Malaise261
Weight Decreased236
Therapeutic Product Effect Incomplete214

Age at onset

Neonate5
Infant8
Child28
Adolescent5
Adult110
Elderly192

Reporter sex

1,943 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization989
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 272 82
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 Smith & Nephew Medical Ltd. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Smith & Nephew Medical Ltd 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.
← 69740-0324-00 · Smith 69740-0328-00 · Smith →
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.