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Desitin Maximum Strength Diaper Rash Zinc Oxide 400 mg/g Paste — NDC 69968-0061-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Desitin Maximum Strength Diaper Rash Zinc Oxide 400 mg/g Paste — NDC 69968-0061-4 (Billing 69968-0061-04)

by Kenvue Brands LLC · 1 TUBE in 1 CARTON / 113 g in 1 TUBE

This is a package of Desitin Maximum Strength Diaper Rash Zinc Oxide 400 mg/g Paste from Kenvue Brands LLC, marketed since Nov 2015 and currently FDA-listed.

NDC 69968-0061-04
🏷️ FDA NDC (as labeled) 69968-0061-4 billing pads the package segment with a zero
This package
Contains113 g in 1 tube Pack sizes7 compare ↓
Product page 69968-0061-01 Also comes in: 28 g 69968-0061-1 57 g 69968-0061-2 136 g 69968-0061-5 3 tubes 69968-0061-3 3.5 g 69968-0061-7 454 g 69968-0061-9
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

⚠️
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) 69968-0061-4
Product NDC 69968-0061
11-digit billing NDC 69968006104
RxCUI 1094560, 1797059
UNII SOI2LOH54Z
Application # M016
SPL Set ID af64fc2f-c027-4a68-b368-ee06744a2452
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-11-16
Route TOPICAL
Dosage form PASTE
Substance ZINC OXIDE

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

GPI-14 90971020004440
GPI class Desitin
GCN Seq No 066050
GCN 28228
HICL code 002324
Ingredient (HICL) Zinc Oxide/Cod Liver Oil
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 DESITIN 40% PASTE
FDB brand name Desitin
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 066050
  • GCN: 28228
  • GPI-14 (Medi-Span): 90971020004440
  • HICL (First Databank): 002324
  • AHFS class code: 84:24.12.00
  • RxCUI (RxNorm): 1094560
Why two NDCs? The FDA registers this code as 69968-0061-4 — a 5-4-1 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 package segment → 69968-0061-04. 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 DESITIN 40% PASTE Ingredient Zinc Oxide/Cod Liver Oil
🧪 What is this product?

Desitin Maximum Strength is a topical paste applied to the skin to help manage diaper rash. It contains zinc oxide at 400 mg per gram, a mineral ingredient typically used in barrier products for minor skin irritation. This is an over-the-counter monograph drug, meaning it is marketed under FDA's established guidelines for diaper rash treatments rather than as an individually approved product.

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: 28 g 57 g 136 g 3 tubes 3.5 g 454 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
69968-0061-01 69968-0061-1 Main listing 1 TUBE in 1 CARTON / 28 g in 1 TUBE 2015-11-16 — Active
69968-0061-02 69968-0061-2 1 TUBE in 1 CARTON / 57 g in 1 TUBE 2015-11-16 — Active
69968-0061-03 69968-0061-3 3 TUBE in 1 CARTON / 136 g in 1 TUBE 2015-11-16 — Active
69968-0061-04 You're viewing this 1 TUBE in 1 CARTON / 113 g in 1 TUBE 2015-11-16 — Active
69968-0061-05 69968-0061-5 1 TUBE in 1 CARTON / 136 g in 1 TUBE 2015-11-16 — Active
69968-0061-07 69968-0061-7 3.5 g in 1 POUCH 2015-11-16 — Active
69968-0061-09 69968-0061-9 454 g in 1 JAR 2015-11-16 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 113 g in 1 tube.
What NDC number is used to bill for this package of Desitin Maximum Strength Diaper Rash Zinc Oxide 400 mg/g Paste?
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
Zinc Oxide 400 mg/g 00363-1020-26 Walgreen 1 tube — — FDA listed —
Diaper Rash 400 mg/g 11344-0020-26 Nice-Pak 1 tube — — FDA listed —
Diaper Rash 400 mg/g 11673-0020-26 Target 1 tube — — Discontinued —
Target Maximum Strength Zinc Oxide Diaper Rash 400 mg/g 11673-0728-40 Target 1 tube — — FDA listed —
Diaper Rash 400 mg/g 37808-0020-26 H 1 tube — — FDA listed —
Diaper Rash 400 mg/g 41250-0412-26 Meijer, 1 tube — — FDA listed —
Diaper Rash 400 mg/g 55910-0020-26 Old 1 tube — — FDA listed —
Zinc Oxide 400 mg/g 69842-0468-26 CVS 1 tube — — FDA listed —
Desitin Maximum Strength Diaper Rash 400 mg/gthis 69968-0061-04 Kenvue 1 tube — — FDA listed —
Desitin Maximum Strength Zinc Oxide Diaper Rash 400 mg/g 69968-0396-01 Kenvue 454 g — — FDA listed —
Desitin Maximum Strength Zinc Oxide Diaper Rash 400 mg/g 69968-0768-01 Kenvue 1 tube — — FDA listed —
Desitin Maximum Strength Zinc Oxide Diaper Rash 400 mg/g 69968-0848-01 Kenvue 454 g — — FDA listed —
CVS Health Diaper Rash 400 mg/g 69842-0058-20 CVS 1 tube — — FDA listed —
Dr. Sheffield Diaper Rash 400 mg/g 11527-0058-40 Sheffield 1 tube — — FDA listed —
Natureplex Diaper Rash 400 mg/g 67234-0001-01 Natureplex 1 tube — — FDA listed —
Walgreens Maximum Diaper Rash 400 mg/g 00363-7280-20 Walgreens 1 tube — — FDA listed —
Diaper Rash 400 mg/g 49035-0952-26 Walmart 1 tube — — FDA listed —
Baby Diaper Rash Cream 400 mg/g 73418-0301-01 Hello 1 tube — — FDA listed —
Diaper Rash 400 mg/g 67091-0020-26 WinCo 1 tube — — FDA listed —
Diaper Rash 400 mg/g 36800-0020-26 Topco 1 tube — — FDA listed —
Diaper Rash 400 mg/g 41163-0020-26 United 1 tube — — FDA listed —
Zinc Oxide 400 mg/g 72288-0989-26 Amazon.com 1 tube — — FDA listed —
Diaper Rash 400 mg/g 30142-0020-26 The 1 tube — — FDA listed —
Zinc Oxide 400 mg/g 11822-0534-01 Rite 1 tube — — FDA listed —
Vitacilina Bebe Diaper Rash 400 mg/g 81929-0002-01 Taisho 1 tube — — FDA listed —
Zinc Oxide 400 mg/g 72476-0920-26 ADUSA 1 tube — — 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

🏛️
2015
On the market since
Nov 2015
📍
2026
Currently FDA-listed
11 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerKenvue Brands LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code69968
First marketedNov 2015
Product typeHuman Otc Drug
Portfolio567 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.

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 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 19 words ▾

Uses helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness

⏱️ Dosage and Administration 38 words ▾

Directions change wet and soiled diapers promptly cleanse the diaper area allow to dry apply paste liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

⚠️ Warnings 58 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 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 right away.

📦 Storage and Handling 13 words ▾

Other information store at 20°C to 25°C (68°F to 77°F) may stain clothing

🧪 Active Ingredient 5 words ▾

Active ingredient Zinc Oxide 40%

🧪 Inactive Ingredients 15 words ▾

Inactive ingredients petrolatum, cod liver oil, lanolin, talc, glycerin, sorbitan sesquioleate, beeswax, tocopheryl acetate, fragrance

🎯 Purpose 3 words ▾

Purpose Skin Protectant

📄 Ask a Doctor Before Use If 25 words ▾

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

📄 When Using This Product 9 words ▾

When using this product do not get into eyes

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Questions or Comments 7 words ▾

Questions? Call toll-free 800-720-3843 or 215-273-8755 (collect)

📄 Package Label / Principal Display Panel 43 words ▾

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton #1 CHOICE OF PEDIATRICIANS & MOMS Desitin ® Maximum Strength provides powerful, long-lasting relief • Paraben-free Zinc Oxide Diaper Rash Paste NET WT 4 Oz (113 g) PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 Kenvue Brands 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 6 other package presentations of this same product, including 1 tube (69968-0061-01), 1 tube (69968-0061-02), 1 tube (69968-0061-05). 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?
Kenvue Brands 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.
← 69968-0060-01 · Kenvue 69968-0073-04 · Kenvue →
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.