Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Skin Protectant Zinc Oxide 25% 25 mg/100mg Ointment — NDC 70000-0488-1 (Billing 70000-0488-01)
by Cardinal Health · 72 BOX in 1 CASE / 1 TUBE in 1 BOX / 28400 mg in 1 TUBE
This is a package of Skin Protectant Zinc Oxide 25% 25 mg/100mg Ointment from Cardinal Health, marketed since Jan 2019 and currently FDA-listed; retail pharmacies pay about $0.0445 per g (NADAC). It is this product's only package size.
NDC 70000-0488-01
🏷️ FDA NDC (as labeled)
70000-0488-1
billing pads the package segment with a zero
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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 70000-0488-1 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 70000 labeler · 0488 product · 1 package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 7000004881 5
- Medicaid fills, this package
- 190 prescriptions in the last four reported quarters
- FDA record last changed
- Oct 8, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
70000-0488-1
Product NDC
70000-0488
11-digit billing NDC
70000048801
NCPDP billing unit
GM — per gram (weight)
RxCUI
238405
UNII
SOI2LOH54Z
Application #
M016
SPL Set ID
8abda4ad-2ef7-9428-e053-2a95a90ac0fb
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2019-01-16
Route
TOPICAL
Dosage form
OINTMENT
Substance
ZINC OXIDE
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
90971020004215
GPI class
Zinc Oxide
GCN Seq No
005577
GCN
22081
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
ZINC OXIDE 25% OINTMENT
FDB brand name
Zinc Oxide
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 005577
- GCN: 22081
- GPI-14 (Medi-Span): 90971020004215
- HICL (First Databank): 002361
- AHFS class code: 84:24.12.00
- RxCUI (RxNorm): 238405
Why two NDCs?
The FDA registers this code as 70000-0488-1 — 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 → 70000-0488-01. 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 8, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
Label name ZINC OXIDE 25% OINTMENT Ingredient Zinc Oxide
🧪 What is this product?
This is an over-the-counter topical ointment containing 25% zinc oxide, marketed under FDA's OTC monograph rules for skin protectants. Zinc oxide is commonly used in skincare products to form a protective barrier on the skin surface. It is typically used to help protect skin from moisture loss and minor irritation.
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 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
💬 Questions about Zinc Oxide 25%?
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 | $0.045 | — |
| Medicaid paysCMS SDUD · 12 mo | $0.1458 | — |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
NADAC price history (per g) — tap or hover for the price & month
▲ Up 11% over the last 11 months.
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 · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 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 |
|---|---|---|---|---|
| 70000-0488-01 You're viewing this Main listing | 72 BOX in 1 CASE / 1 TUBE in 1 BOX / 28400 mg in 1 TUBE | 2019-01-16 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Skin Protectant 25 mg/100mgthis 70000-0488-01 | Cardinal | 1 tube | $0.045 | — | Availability likely | — |
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 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
🏛️
2019
On the market since
Jan 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.
- FDA Orange Book · refreshed Oct 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 7V4MR24V5P
Ceteareth-12 is a synthetic emulsifier made from cetyl and stearyl alcohols combined with ethylene oxide. It helps blend oil and water-based ingredients in medicines, creating a stable, uniform texture.
-
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 N6K5787QVP
Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
-
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.
4 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesCetostearyl Alcohol, Light Mineral Oil, Macrogol Cetostearyl Ether 12, White Soft 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 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 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
LabelerCardinal Health
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedJan 2019
Product typeHuman Otc Drug
Portfolio84 products on file
More NDCs from Cardinal Health labeler code 70000
- LEADER Ear Drops for Swimmers 950 mg/mL Liquid NDC 70000-0478-1
- Mucus Relief Extended Release Maximum Strength Guaifenesin 1200 mg Tablet NDC 70000-0479-1
- Medicated Chest Rub camphor, eucalyptus oil, menthol 48 mg/g; 12 mg/g; 26 mg/g Ointment NDC 70000-0480-1
- leader childrens pain and fever Acetaminophen 160 mg/5mL Suspension NDC 70000-0481-1
- Hydrocortisone Anti-pruritic 1 g/100g Cream NDC 70000-0485-1
- White Petrolatum Skin Protectant 100 g/100g Ointment NDC 70000-0487-1
- Hydrocortisone Anti-Itch 1 g/100g Ointment NDC 70000-0489-1
- Mucus Relief DM Guaifenesin, Dextromethorphan HBr 600 mg; 30 mg Tablet NDC 70000-0491-1
- leader childrens pain and fever Acetaminophen 160 mg/5mL Suspension NDC 70000-0496-1
- Isopropyl alcohol 70 percent 70 mL/100mL Liquid NDC 70000-0497-1
- Isopropyl Rubbing Alcohol 91 percent 91 mL/100mL Liquid NDC 70000-0498-1
- Hydrogen Peroxide 3 Percent 3 mL/100mL Liquid NDC 70000-0500-1
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 8, 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 Dries the oozing and weeping of poison: ivy, oak, sumac
⏱️ Dosage and Administration ▾
Directions For diaper rash: change wet and soiled diapers promptly, cleanse the diaper area and allow to dry, apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged. for poison ivy, oak, and sumac: apply as needed.
⚠️ 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 If swallowed, get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other Information Store at room temperature
🧪 Active Ingredient ▾
Active Ingredient Zinc Oxide 25%
🧪 Inactive Ingredients ▾
Inactive Ingredients Cetostearyl Alcohol, Light Mineral Oil, Macrogol Cetostearyl Ether 12, White Soft Paraffin
🎯 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 ▾
If swallowed, get medical help or contact a Poison Control Center right away.
📄 Questions or Comments ▾
Questions and Comments? 1-888-396-2739
📄 Package Label / Principal Display Panel ▾
Label CR-1190 Zinc Oxide Ointment PDP
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 ↗
Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
190
Units reimbursed last 4 qtrs
6K
Gross reimbursed last 4 qtrs
$877.94
Avg / prescription
$4.62
Avg / unit
$0.1458
Latest quarter Q1 2026
35Rx
Medicaid pays / g
$0.1458
gross reimbursed
vs
NADAC / g
$0.0445
acquisition cost
=
Spread
+$0.1013
+228% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
Fee-for-service · 0 Rx Managed care · 190 Rx
State Medicaid map
Units reimbursed · per 100k residents
6.960.5
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
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 Skin protectant (this brand).
Top reported reactions
Reporter sex
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.
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.