Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
ElixirZincoCare Zinc Oxide 20% 20 g/100g Ointment, 454 g — NDC 84546-0004-3 (Billing 84546-0004-03)
by ELIXIR HEALTHCARE USA, LLC. · 454 g in 1 JAR
This is a package of 454 g of ElixirZincoCare Zinc Oxide 20% 20 g/100g Ointment from ELIXIR HEALTHCARE USA, LLC., marketed since Dec 2025 and currently FDA-listed.
NDC 84546-0004-03
🏷️ FDA NDC (as labeled)
84546-0004-3
billing pads the package segment with a zero
This package
Contains454 g
Pack sizes3 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 →
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
84546-0004-3
Product NDC
84546-0004
11-digit billing NDC
84546000403
RxCUI
198911
UNII
SOI2LOH54Z
Application #
M004
SPL Set ID
bac18496-3b76-4faf-abde-968d79b718d8
Established class (EPC)
Copper Absorption Inhibitor
Physiologic effect
Decreased Copper Ion Absorption
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2025-12-31
Route
TOPICAL
Dosage form
OINTMENT
Substance
ZINC OXIDE
Quick answers
- RxCUI (RxNorm): 198911
Why two NDCs?
The FDA registers this code as 84546-0004-3 — 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 → 84546-0004-03. 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 1, 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?
ElixirZincoCare is a topical ointment containing 20 percent zinc oxide, marketed as an over-the-counter monograph product. Zinc oxide is commonly used in skin-care ointments and creams to form a protective barrier on the skin surface. It is typically applied to areas that need moisture protection or soothing, such as minor skin irritation or diaper rash.
Patient education
Supplement & herbal interactions
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 1, 2026
💬 Questions about Zinc Oxide 20%?
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
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 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 |
|---|---|---|---|---|
| 84546-0004-01 84546-0004-1 Main listing | 1 TUBE in 1 CARTON / 28.3 g in 1 TUBE | 2025-12-31 | — | Active |
| 84546-0004-02 84546-0004-2 | 6 BOX in 1 CASE / 12 PACKET in 1 BOX / 56.7 g in 1 PACKET | 2025-12-31 | — | Active |
| 84546-0004-03 You're viewing this | 454 g in 1 JAR | 2025-12-31 | — | Active |
Pack size FAQ
What quantity is in this package?
This package contains 454 g — 454 g in 1 jar.
How does this package differ from NDC 84546-0004-01?
Both are ElixirZincoCare Zinc Oxide 20% 20 g/100g Ointment — the drug itself is identical. This page's package is the 454 g one, while NDC 84546-0004-01 is the 1 tube package.
What NDC number is used to bill for this package of ElixirZincoCare Zinc Oxide 20% 20 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 |
|---|---|---|---|---|---|---|
| Zinc Oxide 20 g/100g 68001-0533-50 | BluePoint | 454 g | $0.015 | — | Availability likely | — |
| Leader Zinc Oxide 200 mg/g 70000-0334-01 | Cardinal | 454 g | $0.015 | — | 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 | $0.061 | — | Availability likely | — |
| Zinc Oxide 20 g/100g 68001-0532-45 | BluePoint | 1 tube | $0.077 | — | Availability likely | — |
| Nivagen Zinc Oxide 200 mg/g 75834-0170-01 | Nivagen | 28.4 g | $0.105 | — | 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/g 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/100gthis 84546-0004-03 | ELIXIR | 454 g | — | — | FDA listed | — |
| Zinc Oxide Skin Protectant 20 g/100g 87236-0007-16 | Aldermed | 454 g | — | — | FDA listed | — |
| Mineral Sunscreen 20 g/100g 84380-0001-90 | The | 90 g | — | — | FDA listed | — |
| Coppertone Sunscreen SPF 50 20 g/100g 66800-4115-00 | Beiersdorf | 1 cylinder | — | — | 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 Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2025
On the market since
Dec 2025
📍
2026
Currently FDA-listed
1 year 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 Sep 3, 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 I835H2IHHX
A waxy substance derived from plant oils, used as an emulsifier and solubilizer to help mix oil and water ingredients together and keep them blended throughout the product's shelf life.
-
UNII 2DMT128M1S
A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
-
UNII I9O0E3H2ZE
Paraffin is a waxy, petroleum-derived substance used as a coating, lubricant, and hardening agent in tablets and capsules. It helps protect the medicine from moisture and gives pills a smooth finish.
-
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.
4 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesCetostearyl Alcohol, Cetomacrogol-1000, Lanoline Anhydrous, White Petroleum Jelly, Light Liquid Paraffin
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 1, 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
LabelerELIXIR HEALTHCARE USA, LLC.
FDA applicationM004 (OTC MONOGRAPH DRUG)
Labeler code84546
First marketedDec 2025
Product typeHuman Otc Drug
Portfolio8 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 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
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
📄 Do Not Use
📄 Ask a Doctor Before Use If
📄 Stop Use and Ask a Doctor If
📄 Keep Out of Reach of Children
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness. dries the oozing and weeping of poison ivy, poison oak and poison sumac
⏱️ Dosage and Administration ▾
Directions apply liberally as often as necessary For diaper rash: • change wet or soiled diapers promptly • cleanse the diaper area and allow to dry • apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged
⚠️ Warnings ▾
Warnings For external use only
🧪 Active Ingredient ▾
Active Ingredient (in each gram) Zinc Oxide 20% w/w
🧪 Inactive Ingredients ▾
Inactive ingredients Cetostearyl Alcohol, Cetomacrogol-1000, Lanoline Anhydrous, White Petroleum Jelly, Light Liquid Paraffin
🎯 Purpose ▾
Purpose First Aid Antibiotic
📄 Do Not Use ▾
Do not use • For external use only • When using this product, avoid contact with the eyes • Stop use and ask a doctor if condition worsens or does not improve within 7 days Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away
📄 Ask a Doctor Before Use If ▾
Ask a doctor before use in case of • deep or puncture wounds • animal bites • serious burns
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if • condition persists or gets worse • a rash or other allergic reaction develops
📄 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.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL Zinc Oxide Ointment Skin Protectant • 2 oz Reorder No. xxxx Individually Boxed • 12 Tubes per Pack Each Tube Net Weight 2 oz Gross Wt. 5.300 kg Net Wt. 4.075 kg 72 Tubes Elixir 12tubes
PRINCIPAL DISPLAY PANEL Zinc Oxide Ointment Skin Protectant • 1 oz Net Wt. 1 OZ (28.3 g) Reorder No. xxxx Elixir Tube Lable.jpg
PRINCIPAL DISPLAY PANEL ZINC OXIDE OINTMENT ZINC OXIDE 20% Skin Protectant 15 OZ. Jars • 12 Jars per Case Reorder No.: ______ jar
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 ↗
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 ELIXIR HEALTHCARE USA, 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 2 other package presentations of this same product, including 1 tube (84546-0004-01), 12 packets (84546-0004-02). 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?
ELIXIR HEALTHCARE USA, 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.