Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Triple 3x Max Diaper Rash ZINC OXIDE 40 g/100g Ointment, 340 g — NDC 16864-061-04 (Billing 16864-0061-04)
by Advantice Health, LLC · 340 g in 1 JAR
This is a package of 340 g of Triple 3x Max Diaper Rash ZINC OXIDE 40 g/100g Ointment from Advantice Health, LLC, marketed since May 2024 and currently FDA-listed.
NDC 16864-0061-04
🏷️ FDA NDC (as labeled)
16864-061-04
billing pads the product segment with a zero
This package
Contains340 g
Pack sizes4 compare ↓
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 16864-061-04 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 16864 labeler · 061 product · 04 package
- Package marketed since
- May 15, 2024
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 1686406104 1
- 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)
16864-061-04
Product NDC
16864-061
11-digit billing NDC
16864006104
UNII
SOI2LOH54Z
Application #
M016
SPL Set ID
e554046b-cd0a-4a6e-8f24-2e610c697432
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2024-05-15
Route
TOPICAL
Dosage form
OINTMENT
Substance
ZINC OXIDE
Why two NDCs?
The FDA registers this code as 16864-061-04 — 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 → 16864-0061-04. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
🧪 What is this product?
Triple 3x Max Diaper Rash is a topical ointment containing zinc oxide as its active ingredient. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established rules for this category rather than being individually reviewed. Zinc oxide is commonly used in diaper rash products to create a moisture barrier on the skin and is typically applied to affected areas to help protect skin from irritation.
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
💬 Questions about ZINC OXIDE?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 6, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 16864-0061-01 16864-061-01 Main listing | 1 TUBE in 1 CARTON / 57 g in 1 TUBE | 2024-05-15 | — | Active |
| 16864-0061-02 16864-061-02 | 170 g in 1 TUBE | 2024-10-15 | — | Active |
| 16864-0061-03 16864-061-03 | 284 g in 1 JAR | 2025-12-01 | — | Active |
| 16864-0061-04 You're viewing this | 340 g in 1 JAR | 2024-05-15 | — | Active |
Pack size FAQ
What quantity is in this package?
This package contains 340 g — 340 g in 1 jar.
How does this package differ from NDC 16864-0061-02?
Both are Triple 3x Max Diaper Rash ZINC OXIDE 40 g/100g Ointment — the drug itself is identical. This page's package is the 340 g one, while NDC 16864-0061-02 is the 170 g package.
What NDC number is used to bill for this package of Triple 3x Max Diaper Rash ZINC OXIDE 40 g/100g 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Burts Bees Baby Bee Diaper Rash 40 g/100g 26052-0028-01 | BURT'S | 85 g | — | — | FDA listed | — |
| Triple 3x Max Diaper Rash 40 g/100gthis 16864-0061-04 | Advantice | 340 g | — | — | FDA listed | — |
| Diaper Rash Cream 2oz 40 g/100g 57337-0164-01 | Rejoice | 1 tube | — | — | FDA listed | — |
| Diaper Rash Cream 40% ZINC 40 g/100g 77338-0164-01 | ASTONEA | 1 tube | — | — | FDA listed | — |
| Diaper Rash Cream 2.5oz 40 g/100g 57337-0165-01 | Rejoice | 1 tube | — | — | FDA listed | — |
| Best Choice Diaper Rash 40 g/100g 69396-0152-01 | Trifecta | 113 g | — | — | FDA listed | — |
| Diaper Rash Cream 5.6oz 40 g/100g 57337-0170-01 | Rejoice | 160 g | — | — | FDA listed | — |
| Aquaphor Healing Fast Relief Diaper Rash 40 g/100g 10356-0115-10 | Beiersdorf | 99 g | — | — | FDA listed | — |
| Diaper Rash Cream 5.6oz 40 g/100g 58503-0202-01 | China | 160 g | — | — | FDA listed | — |
| Diaper Rash Cream 15oz 40 g/100g 58503-0205-01 | China | 425 g | — | — | FDA listed | — |
| Quality Choice Diaper Rash 40 g/100g 83324-0042-01 | Chain | 113 g | — | — | FDA listed | — |
| Diaper Rash Cream 15oz 40 g/100g 57337-0169-01 | Rejoice | 425 g | — | — | FDA listed | — |
| Earth Baby Diaper Rash Cream 40 g/100g 62588-0904-02 | Earth | 1 tube | — | — | FDA listed | — |
| DiaperRashOintment 40 g/100g 68016-0128-20 | Pharmacy | 113 g | — | — | FDA listed | — |
| Diaper Rash 40 g/100g 87236-0018-04 | Aldermed | 113 g | — | — | FDA listed | — |
| Drs. Pharmacy Baby Healing 40 g/100g 80489-0904-01 | OL | 50 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2024
On the market since
May 2024
📍
2026
Currently FDA-listed
2 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.
- FDA Orange Book · refreshed Oct 3, 2026
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.
- FDA label on DailyMed · label index refreshed Oct 6, 2026
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 36HQN158VC
Alpha-bisabolol is a naturally derived oily liquid from plant sources. It works as a fragrance, flavor, and skin-conditioning agent in topical medicines and cosmetic products.
-
UNII 2ZA36H0S2V
Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.
-
UNII 97C5T2UQ7J
Cholesterol is a fatty substance found naturally in animal tissues. In medications, it's used as an ingredient in liposomal formulations and lipid-based drug delivery systems to help encapsulate and stabilize active drugs for better absorption.
-
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
UNII 7EV65EAW6H
Lanolin is a waxy substance derived from sheep's wool. It's used in medicines as an emollient and skin-conditioning agent to soften formulations and improve spreadability in topical products like creams and ointments.
-
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 Z6J799EAJK
Oat is a cereal grain used in medicines as a filler and binder. It helps give the medication its shape and structure while adding bulk to the formulation.
-
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.
-
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.
-
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.
10 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesavena sativa (oat) kernel extract, beeswax, bisabolol, cholesterol, glycerin, lanolin, mineral oil, water, white petrolatum, zea mays (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.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerAdvantice Health, LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code16864
First marketedMay 2024
Product typeHuman Otc Drug
Portfolio11 products on file
More NDCs from Advantice Health, LLC labeler code 16864
- Triple Diaper Rash Zinc Oxide 12.8 g/100g Ointment NDC 16864-021-01
- TriplePaste Adult Care Rash Treatment Zinc Oxide 12.8 g/100g Paste NDC 16864-031-01
- Triple Antifungal Miconazole Nitrate 2 g/100g Ointment NDC 16864-040-02
- multipurpose Zinc Oxide Skin Protectant 12.8 g/100g Ointment NDC 16864-041-01
- Kerasal for Athletes Foot Silky Clear TOLNAFTATE 1 g/100g Gel NDC 16864-100-01
- Kerasal Athletes Foot powder Tolnaftate 1 g/100g Spray NDC 16864-110-01
- Kerasal Athletes Foot Rapid Symptom Relief Medicated Soak Aluminum Sulfate Tetradecahydrate and Calcium Acetate Monohydrate 1347 mg; 952 mg Powder, For Solution NDC 16864-140-01
- Domeboro Aluminum Sulfate Tetradecahydrate, Calcium Acetate Monohydrate 1347 mg; 952 mg Powder, For Solution NDC 16864-240-01
- New Skin Bandage Benzethonium Chloride 1.8 mg/mL Liquid NDC 16864-440-01
- New Skin Bandage Benzethonium Chloride 60 mg/g Spray NDC 16864-450-01
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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📄 When Using This Product
📄 Stop Use and Ask a Doctor If
📄 Keep Out of Reach of Children
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps protect from wetness
⏱️ Dosage and Administration ▾
Directions change wet and soiled diapers promptly cleanse the diaper area and allow skin to dry apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time exposure to wet diapers may be prolonged
⚠️ Warnings ▾
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 ▾
Other information Store at room temperature 15°-30°C (59°-86°F)
🧪 Active Ingredient ▾
Active ingredient Zinc oxide 40%
🧪 Inactive Ingredients ▾
Inactive ingredients avena sativa (oat) kernel extract, beeswax, bisabolol, cholesterol, glycerin, lanolin, mineral oil, water, white petrolatum, zea mays (corn) starch
🎯 Purpose ▾
Purpose Skin protectant
📄 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
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
📄 Questions or Comments ▾
Questions? 1-800-345-0032
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 57 g Tube Carton PEDIATRICIAN RECOMMENDED TRIPLE PASTE ® 40% Zinc Oxide / Skin Protectant ACCEPTED e National Eczema Association Diaper Rash Relief 3X* MAX 3X ZINC OXIDE PLUS SKIN NOURISHING INGREDIENTS Oat Extract Beeswax Glycerin Fragrance Free • Hypoallergenic • Talc Free Prevents • Treats • Soothes Net Wt. 2oz. (57g) Principal Display Panel - 57 g Tube Carton
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 ↗
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 Triple 3x Max Diaper Rash (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.
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 Advantice Health, 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 3 other package presentations of this same product, including 1 tube (16864-0061-01), 170 g (16864-0061-02), 284 g (16864-0061-03). 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?
Advantice Health, 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.
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.