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Attitude Diaper Cream Zinc Unscented Zinc oxide 15 g/100g Stick, 30 g — NDC 61649-0260-01 package photo

Attitude Diaper Cream Zinc Unscented Zinc oxide 15 g/100g Stick, 30 g

by 9055-7588 Quebec Inc. (Attitude) · 30 g in 1 TUBE (61649-260-01)
NDC 61649-0260-01
🏷️ FDA NDC (as labeled) 61649-260-01 billing pads the product segment with a zero
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 →

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

FDA NDC (as labeled) 61649-260-01
Product NDC 61649-260
11-digit billing NDC 61649026001
RxCUI 245660
UNII SOI2LOH54Z
UPC 0626232182606
Application # M016
SPL Set ID 00283894-ddc6-0faa-e063-6394a90ae47c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-07-24
Route TOPICAL
Dosage form STICK
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 61649-260-01 — 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 → 61649-0260-01. 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

Labeler9055-7588 Quebec Inc. (Attitude)
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code61649
First marketedJul 2023
Product typeHuman Otc Drug
Portfolio2 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?

This is an over-the-counter topical diaper cream in stick form containing 15% zinc oxide. Zinc oxide is commonly used in barrier creams applied to the skin to help protect against moisture and irritation. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for diaper rash and skin protectant products rather than undergoing individual review.

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.

🧪 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 66YXD4DKO9
    A natural oil extracted from almond kernels. It's used in medicines as an emollient and solvent to help dissolve or suspend active ingredients and improve texture in topical and oral formulations.
  • UNII K8NU647RJ0
    Behenyl behenate is a waxy ester derived from behenic acid. It acts as a lubricant and glidant in tablets and capsules to reduce friction during manufacturing and improve powder flow.
  • UNII 43AGM4PHPI
    A mixture of plant or animal oils and fats with 10 to 18 carbon chains. Used as a solvent and carrier to dissolve or suspend active ingredients, helping deliver the medicine effectively.
  • UNII WL0328HX19
    A natural plant-based wax derived from candelilla shrub leaves. It acts as a coating agent, hardener, and texture modifier to control how quickly the medicine releases and to improve the tablet or capsule's appearance and stability.
  • UNII D5340Y2I9G
    Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.
  • UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII A626UU0W2A
    Glyceryl monobehenate is a waxy substance made from glycerin and behenic acid. It's used as a binder and lubricant to help hold tablet ingredients together and improve how smoothly the medicine flows during manufacturing.
  • UNII 930MLC8XGG
    A plant oil extracted from grape seeds, used as an emollient and solvent in medicines. It helps dissolve active ingredients and improve the texture and absorption of topical or liquid formulations.
  • UNII 42DG15CHXV
    A natural plant wax derived from sunflower seeds. It serves as a lubricant and glidant to help powders flow smoothly during manufacturing and tablet formation.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII YXH47AOU0F
    A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
  • UNII Y4U591OU70
    A plant extract from bilberry leaves used in some formulations as a natural flavoring agent or coloring component. It may also serve as an antioxidant to help preserve the medicine's stability.

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

The official label also statesCocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Polyhydroxystearic Acid, Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Wax, Vitis Vinifera (Grape) Seed Oil, C10-18 Triglycerides, Behenyl Behenate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Glyceryl Behenate, Euphorbia Cerifera (Candelilla) Wax, Vaccinium Myrtillus (Blueberry) Leaf Extract.

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 systemPer eachPer 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Aquaphor Healing Diaper Rash 15 g/100g 10356-0105-02 Beiersdorf 7 g — — FDA listed —
Attitude Diaper Cream Zinc Unscented 15 g/100gthis 61649-0260-01 9055-7588 30 g — — FDA listed —
ZOEY NATURALS DIAPER Cream 15 g/100mL 70793-0010-34 Absolutely 1 tube — — FDA listed —
Diaper Rash Cream 15 g/100g 83369-0002-01 Smalls 85 g — — FDA listed —
Elta MD UV AOX Eye 15 g/100g 72043-4342-01 CP 1 tube — — FDA listed —
Impeccable Skin Moisturizing Face Sunscreen Broad Spectrum SPF 30 15 g/100g 56152-0100-01 Cosmetic 56.7 g — — FDA listed —
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Tan 15 g/100g 56152-0260-01 Cosmetic 7.1 g — — FDA listed —
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Buff 15 g/100g 56152-0259-01 Cosmetic 7.1 g — — FDA listed —
Hawaiian Tropic Mineral Skin Nourishing Milk Sunscreen Broad Spectrum SPF 30 15 g/100g 63354-0421-12 Edgewell 100 g — — FDA listed —
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Mocha 15 g/100g 56152-0264-01 Cosmetic 7.1 g — — FDA listed —
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Ivory 15 g/100g 56152-0263-01 Cosmetic 7.1 g — — FDA listed —
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Nude 15 g/100g 56152-0261-01 Cosmetic 7.1 g — — FDA listed —
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Sand 15 g/100g 56152-0258-01 Cosmetic 7.1 g — — FDA listed —
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Bronze 15 g/100g 56152-0262-01 Cosmetic 7.1 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

🏛️
2023
On the market since
Jul 2023
📍
2026
Currently FDA-listed
3 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 Attitude Diaper Cream Zinc Unscented (this brand).

Top reported reactions

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

Reporter sex

0 reports

Serious outcomes

Death204
Disabling32
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 272 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
61649-0260-01 You're viewing this 30 g in 1 TUBE (61649-260-01) 2023-07-24 Active

🧭 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 61649-260-01, 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: 61649-0260-01, written without dashes as 61649026001. 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 61649-0260-01, the first segment (61649) is the labeler code FDA assigned to 9055-7588 Quebec Inc. (Attitude); the middle segment (0260) 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 9055-7588 Quebec Inc. (Attitude). Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
9055-7588 Quebec Inc. (Attitude) 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 36 words ▾

Helps prevent diaper rash. Protects chafed irritated skin due to diaper rash. Helps protect from wetness that causes diaper rash. Temporarily protects and helps relieve minor skin irritation due to diaper rash. Helps treat/heal diaper rash.

⏱️ Dosage and Administration 76 words ▾

Change wet and soiled diapers promptly, cleanser the diaper area, and allow to dry. Push on the bottom to release the product. Heat the product for a few seconds on your hands and apply on baby's bottom. Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged. If necessary, after use, wipe off the excess on the tube contour before closing it.

⚠️ Warnings 56 words ▾

Allergens: almond For external use only. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and consult a doctor if symptoms worsen or last for more than 7 days. Keep out of reach of children. If swallowed, call a poison control centre or get edical help right away.

📦 Storage and Handling 8 words ▾

Store at temperatures below 90 F (32 C).

🧪 Active Ingredient 3 words ▾

Zinc oxide (15%)

🧪 Inactive Ingredients 44 words ▾

Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Polyhydroxystearic Acid, Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Wax, Vitis Vinifera (Grape) Seed Oil, C10-18 Triglycerides, Behenyl Behenate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Glyceryl Behenate, Euphorbia Cerifera (Candelilla) Wax, Vaccinium Myrtillus (Blueberry) Leaf Extract.

🎯 Purpose 6 words ▾

Skin protectant - Diaper rash treatment

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 61649-0179-01 · 9055-7588 61649-0293-01 · 9055-7588 →
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.