Zinc Oxide 20% .2 g/g Ointment
by Trifecta Pharmaceuticals USA · 1 TUBE in 1 BOX (69396-021-02) / 60 g in 1 TUBE
NDC 69396-0021-02
🏷️ FDA NDC (as labeled)
69396-021-02
billing pads the product segment with a zero
This package
Contains60 g in 1 tube
Pack sizes2 compare ↓
Also comes in:
454 g 69396-0021-54
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 →
⚠️
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)
69396-021-02
Product NDC
69396-021
11-digit billing NDC
69396002102
NCPDP billing unit
GM — per gram (weight)
RxCUI
198911
UNII
SOI2LOH54Z
UPC
0860001004922
Application #
M016
SPL Set ID
8cbe9b1f-fec0-9579-e053-2995a90ac461
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2019-07-01
Route
TOPICAL
Dosage form
OINTMENT
Substance
ZINC OXIDE
GPI-14
90971020004210
GPI class
Zinc Oxide
Why two NDCs?
The FDA registers this code as 69396-021-02 — 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 → 69396-0021-02. 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
LabelerTrifecta Pharmaceuticals USA
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code69396
First marketedJul 2019
Product typeHuman Otc Drug
Portfolio11 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 ointment containing zinc oxide, a mineral ingredient commonly used in skin-care products. Zinc oxide is typically used as a protective barrier on the skin and is found in many diaper-rash ointments, sunscreens, and general-purpose skin-protection products. This ointment is marketed under FDA's OTC monograph rules for its category rather than as an individually reviewed new drug application.
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.
💬 Questions about Zinc Oxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 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.
2 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesMineral Oil, Petrolatum
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 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
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:
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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Zinc Oxide 20 g/100g 68001-0533-50 | BluePoint | 454 g | $0.016 | — | Availability likely | — |
| Leader Zinc Oxide 200 mg/g 70000-0334-01 | Cardinal | 454 g | $0.016 | — | Availability likely | — |
| Good Neighbor Pharmacy Skin Protectant .2 g/g 46122-0676-46 | AMERISOURCE | 1 tube | $0.036 | — | Availability likely | — |
| Rugby Zinc Oxide 20% 20 g/100g 00536-1316-25 | Rugby | 72 tubes | $0.059 | — | Availability likely | — |
| Zinc Oxide 20 g/100g 68001-0532-45 | BluePoint | 1 tube | $0.079 | — | Availability likely | — |
| Nivagen Zinc Oxide 200 mg/g 75834-0170-01 | Nivagen | 28.4 g | $0.107 | — | Availability likely | — |
| Sheffield Zinc Oxide 200 mg/g 11527-0065-34 | Sheffield | 1 tube | — | — | FDA listed | — |
| CAREALL Zinc Oxide .2 g/g 51824-0032-03 | New | 28 g | — | — | FDA listed | — |
| ProCure Zinc Oxide 20 g/100g 55681-0017-01 | Twin | 28.3 g | — | — | FDA listed | — |
| Procure 20 g/100g 55681-0304-03 | TWIN | 28.3 g | — | — | FDA listed | — |
| Endit Zinc Oxide Skin Protectant 20 g/100g 64068-0402-01 | Endit | 454 g | — | — | FDA listed | — |
| Endit zinc oxide skin protection 200 mg/g 64068-0500-01 | EndIt | 56.7 g | — | — | FDA listed | — |
| Zinc Oxide .2 g/g 64772-0201-01 | Derma | 453.6 g | — | — | FDA listed | — |
| Zinc Oxide 200 mg/g 67777-0223-02 | Dynarex | 1 tube | — | — | FDA listed | — |
| Zinc Oxide 20% .2 g/g 68016-0159-02 | Pharmacy | 1 tube | — | — | FDA listed | — |
| dabur 20 g/100g 68747-3040-03 | Dabur | 28 g | — | — | FDA listed | — |
| Zinc Oxide 20% .2 g/gthis 69396-0021-02 | Trifecta | 1 tube | — | — | FDA listed | — |
| Zinc Oxide 20% .2 g/g 69396-0086-02 | Trifecta | 1 tube | — | — | FDA listed | — |
| zinc oxide 20% 20 g/100g 69452-0450-58 | Bionpharma | 425 g | — | — | FDA listed | — |
| Zinc Oxide 20 g/100g 69771-0109-38 | Geri-Gentle | 1 tube | — | — | FDA listed | — |
| CVS Zinc Oxide 200 mg/g 69842-0065-34 | CVS | 1 tube | — | — | FDA listed | — |
| Medpura Zinc Oxide 20% 20 g/100g 71399-0245-02 | Akron | 1 tube | — | — | FDA listed | — |
| Zinc Oxide 20% .2 g/g 83324-0052-01 | Chain | 1 tube | — | — | FDA listed | — |
| Zinc Oxide Pharma 200 mg/g 84387-0001-01 | ALLIED | 56.6 g | — | — | FDA listed | — |
| ElixirZincoCare 20 g/100g 84546-0004-01 | ELIXIR | 1 tube | — | — | FDA listed | — |
| Zinc Oxide Skin Protectant 20 g/100g 87236-0007-16 | Aldermed | 454 g | — | — | FDA listed | — |
| 78 x 36 SPF 30 Active .2 g/g 58466-0109-03 | Dermazone | 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
🏛️
2019
On the market since
Jul 2019
📍
2026
Currently FDA-listed
7 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 Zinc Oxide — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 36%
Female · 64%
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 69396-0021-02 You're viewing this | 1 TUBE in 1 BOX (69396-021-02) / 60 g in 1 TUBE | 2018-01-26 | Active |
| 69396-0021-54 | 1 JAR in 1 JAR (69396-021-54) / 454 g in 1 JAR | 2019-07-01 | Active |
Pack size FAQ
What quantity is in NDC 69396-0021-02?
NDC 69396-0021-02 is listed by the FDA — 1 tube in 1 box / 60 g in 1 tube.
What NDC number is used to bill for this package of Zinc Oxide 20% .2 g/g Ointment?
Bill NDC 69396-0021-02 — the 11-digit billing format is 69396002102. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 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 | — Not published for this NDC No photo available yet for this listing. |
| 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 69396-021-02, 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: 69396-0021-02, written without dashes as 69396002102. 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 69396-0021-02, the first segment (69396) is the labeler code FDA assigned to Trifecta Pharmaceuticals USA; the middle segment (0021) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Trifecta Pharmaceuticals USA. 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 1 other package presentation of this same product, including 1 jar (69396-0021-54). 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?
Trifecta Pharmaceuticals USA 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 ▾
Uses Protects skin Protects and releives chafed skin due to diaper rash - helps seal out wetness Dries the oozing and weeping of poison ivy, oak and sumac
⏱️ Dosage and Administration ▾
Directions Apply ointment liberally as often as necessary For the treatment of diaper rash, change wet and soiled diapers promptly Cleanse the diaper area and allow to dry Apply with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged
⚠️ Warnings ▾
Warnings For External Use Only When using this product avoid contact with eyes Stop use and ask a doctor if condition worsens or does not improve within 7 days. This may be a sign of a serious condition.
📦 Storage and Handling ▾
Other Information Store at controlled room temperature 15° - 30°C (59° - 86°F)
🧪 Active Ingredient ▾
Active Ingredient Zinc Oxide 20%
🧪 Inactive Ingredients ▾
Inactive Ingredients Mineral Oil, Petrolatum
🎯 Purpose ▾
Purpose Skin Protectant
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 ↗
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.