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Triple Diaper Rash Zinc Oxide 12.8 g/100g Ointment, 1 tube — NDC 16864-0021-06 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Triple Diaper Rash Zinc Oxide 12.8 g/100g Ointment, 1 tube — NDC 16864-021-06 (Billing 16864-0021-06)

by Advantice Health, LLC · 1 TUBE in 1 CARTON / 11.5 g in 1 TUBE

This is a package of 1 tube of Triple Diaper Rash Zinc Oxide 12.8 g/100g Ointment from Advantice Health, LLC, marketed since May 2021 and currently FDA-listed.

NDC 16864-0021-06
🏷️ FDA NDC (as labeled) 16864-021-06 billing pads the product segment with a zero
This package
Contains1 tube Pack sizes7 compare ↓
Product page 16864-0021-01 Also comes in: 57 g 16864-021-01 85 g 16864-021-02 6 g 16864-021-07 227 g 16864-021-03 283 g 16864-021-04 454 g 16864-021-05
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 16864-021-06 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
16864 labeler · 021 product · 06 package
Package marketed since
May 15, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 1686402106 9
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) 16864-021-06
Product NDC 16864-021
11-digit billing NDC 16864002106
RxCUI 637168, 729935
UNII SOI2LOH54Z
Application # M016
SPL Set ID d457c58d-8239-41c4-999e-d0ba237e3945
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-05-15
Route TOPICAL
Dosage form OINTMENT
Substance ZINC OXIDE

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

GPI-14 90971020004277
GPI class Triple Paste
GCN Seq No 062770
GCN 98544
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 TRIPLE PASTE 12.8% OINTMENT
FDB brand name Triple Paste
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 062770
  • GCN: 98544
  • GPI-14 (Medi-Span): 90971020004277
  • HICL (First Databank): 002361
  • AHFS class code: 84:24.12.00
  • RxCUI (RxNorm): 637168
Why two NDCs? The FDA registers this code as 16864-021-06 — 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 → 16864-0021-06. 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 TRIPLE PASTE 12.8% OINTMENT Ingredient Zinc Oxide
🧪 What is this product?

Triple Diaper Rash is a topical ointment containing zinc oxide, an over-the-counter monograph product marketed under FDA category rules rather than as an individually reviewed drug application. Zinc oxide is commonly used in skin-care products as a protective barrier ingredient. This ointment form is typically applied directly to the skin in areas prone to moisture and friction.

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: 57 g 85 g 6 g 227 g 283 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
16864-0021-01 16864-021-01 Main listing 1 TUBE in 1 CARTON / 57 g in 1 TUBE 2021-05-15 — Active
16864-0021-02 16864-021-02 1 TUBE in 1 CARTON / 85 g in 1 TUBE 2021-05-15 — Active
16864-0021-03 16864-021-03 227 g in 1 JAR 2021-05-15 — Active
16864-0021-04 16864-021-04 283 g in 1 JAR 2021-05-15 — Active
16864-0021-05 16864-021-05 454 g in 1 JAR 2021-05-15 — Active
16864-0021-06 You're viewing this 1 TUBE in 1 CARTON / 11.5 g in 1 TUBE 2021-05-15 — Active
16864-0021-07 16864-021-07 6 g in 1 PACKET Sample 2024-05-01 — Active

Pack size FAQ

What quantity is in this package?
This package contains 1 tube — 1 tube in 1 carton / 11.5 g in 1 tube.
How does this package differ from NDC 16864-0021-07?
Both are Triple Diaper Rash Zinc Oxide 12.8 g/100g Ointment — the drug itself is identical. This page's package is the 1 tube one, while NDC 16864-0021-07 is the 6 g package.
What NDC number is used to bill for this package of Triple Diaper Rash Zinc Oxide 12.8 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Triple Diaper Rash 12.8 g/100gthis 16864-0021-06 Advantice 1 tube — — FDA listed —
TriplePaste Adult Care Rash Treatment 12.8 g/100g 16864-0031-01 Advantice 227 g — — FDA listed —
multipurpose 12.8 g/100g 16864-0041-01 Advantice 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

🏛️
2021
On the market since
May 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.

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.

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 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 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • 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 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • 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.
  • 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.

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

The official label also stateswhite petrolatum, com starch, anhydrous lanolin, stearyl alcohol, beeswax, bisabolol, cholesterol, water, glycerin, oat (avena saliva) kernel 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.

Manufacturer & labeler

LabelerAdvantice Health, LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code16864
First marketedMay 2021
Product typeHuman Otc Drug
Portfolio11 products on file

More NDCs from Advantice Health, LLC labeler code 16864

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 📄 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 19 words ▾

Uses helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps protect from wetness

⏱️ Dosage and Administration 40 words ▾

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 lime 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 8 words ▾

Other information Store at room temperature 15°-30°C (59°-86°F)

🧪 Active Ingredient 5 words ▾

Active ingredient Zinc oxide 12.8%

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients white petrolatum, com starch, anhydrous lanolin, stearyl alcohol, beeswax, bisabolol, cholesterol, water, glycerin, oat (avena saliva) kernel extract.

🎯 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 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.

📄 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 2 words ▾

Questions? 1-800-345-0032

📄 Package Label / Principal Display Panel 55 words ▾

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton PEDIATRICIAN RECOMMENDED TRIPLE PASTE ® 12.8% Zinc Oxide / Skin Protectant All-in-One TRIPLE PROTECTION PREVENTS stops diaper rash before it starts TREATS restores irritated skin to health SOOTHES immediate soothing relief for sensitive skin •Fragrance-free• Net Wt. 3oz. (85g) Principal Display Panel - 85 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) ✓ 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 6 other package presentations of this same product, including 1 tube (16864-0021-01), 1 tube (16864-0021-02), 6 g (16864-0021-07). 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.
← 16837-0891-25 · Kenvue 16864-0031-01 · Advantice →
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.