HomeNDC LookupIngredientsRugby Zinc Oxide 20% › 00536-1316-25
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Rugby Zinc Oxide 20% 20 g/100g Ointment

by Rugby Laboratories · 72 TUBE in 1 CASE (0536-1316-25) / 60 g in 1 TUBE
NDC 00536-1316-25
🏷️ FDA NDC (as labeled) 0536-1316-25 billing pads the labeler segment with a zero
This package
Contains60 g in 1 tube Cost per g$0.0585 NADAC Per package$252.72 / 4320 g Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.1321/unit — full pricing hub ↓
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 →

🆔 Identity & classification

FDA NDC (as labeled) 0536-1316-25
Product NDC 0536-1316
11-digit billing NDC 00536131625
NCPDP billing unit GM — per gram (weight)
RxCUI 198911
UNII SOI2LOH54Z
UPC 0305361316259, 0305361316983, 0305361316280
Application # M016
SPL Set ID b96f6697-c912-7d62-e053-2a95a90a9f5b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-03-01
Route TOPICAL
Dosage form OINTMENT
Substance ZINC OXIDE
GPI-14 90971020004210
GPI class Zinc Oxide
GCN Seq No 005576
GCN 22080
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 20% OINTMENT
FDB brand name Zinc Oxide
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0536-1316-25 — a 4-4-2 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 labeler segment → 00536-1316-25. 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

LabelerRugby Laboratories
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code00536
First marketedMar 2021
Product typeHuman Otc Drug
Portfolio149 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

Label name ZINC OXIDE 20% OINTMENT Ingredient Zinc Oxide
🧪 What is this product?

Rugby Zinc Oxide 20% is an over-the-counter ointment applied to the skin. Zinc oxide is a topical ingredient commonly used in products meant to protect skin and provide a moisture barrier. This product is marketed as an OTC monograph drug, meaning it is made according to FDA category rules rather than as an individually reviewed application.

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.

💊 What it looks like

ShapeFreeform
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 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 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 statesCetomacrogol 1000, Cetostearyl Alcohol, Light Mineral Oil, White Soft Paraffin (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 DailyMedingredient 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 systemPer gPer package
Retail pharmacies payNADAC · weekly $0.059 $252.72 / 4320 g
Medicaid paysCMS SDUD · 12 mo $0.1321 $570.67 / 4320 g
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
Dec 2023 Jan 2026 Apr 2026 Aug 2026 $0.060 $0.057
▲ Up 1% 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Zinc Oxide 20 g/100g 68001-0533-50 BluePoint 454 g $0.016 Availability likely save 73%
Leader Zinc Oxide 200 mg/g 70000-0334-01 Cardinal 454 g $0.016 Availability likely save 73%
Good Neighbor Pharmacy Skin Protectant .2 g/g 46122-0676-46 AMERISOURCE 1 tube $0.036 Availability likely save 38%
Rugby Zinc Oxide 20% 20 g/100gthis 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 +34%
Nivagen Zinc Oxide 200 mg/g 75834-0170-01 Nivagen 28.4 g $0.107 Availability likely +82%
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/100g 84546-0004-01 ELIXIR 1 tube FDA listed
Zinc Oxide Skin Protectant 20 g/100g 87236-0007-16 Aldermed 454 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.

Availability & generic status

🏛️
2021
On the market since
Mar 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.

🗺️ 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 00536-1316-25, 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 – Q4 2025 · 4 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
17.2K
Units reimbursed last 4 qtrs
1.2M
Gross reimbursed last 4 qtrs
$154K
Avg / prescription
$8.97
Avg / unit
$0.1321
Latest quarter Q4 2025
4.5KRx
Medicaid pays / g
$0.1321
gross reimbursed
vs
NADAC / g
$0.0585
acquisition cost
=
Spread
+$0.0736
+126% 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
79% FFS 21% MCO
Fee-for-service · 13,608 Rx Managed care · 3,562 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 7,167 units · 125 per 100k residents MN Wisconsin: 6,705 units · 113 per 100k residents WI Michigan: no data reported MI New York: 630,809 units · 3,223 per 100k residents NY Vermont: no data reported VT New Hampshire: 960 units · 68.5 per 100k residents NH Oregon: 19,560 units · 462 per 100k residents OR Nevada: 2,790 units · 87.4 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 18,390 units · 147 per 100k residents IL Indiana: 8,975 units · 131 per 100k residents IN Ohio: 78,480 units · 666 per 100k residents OH Pennsylvania: 33,745 units · 260 per 100k residents PA New Jersey: 10,665 units · 115 per 100k residents NJ Massachusetts: 19,828 units · 283 per 100k residents MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 5,188 units · 262 per 100k residents NE Missouri: no data reported MO Kentucky: 189,356 units · 4,184 per 100k residents KY West Virginia: no data reported WV Virginia: 7,554 units · 86.7 per 100k residents VA Maryland: 3,025 units · 48.9 per 100k residents MD Connecticut: 1,500 units · 41.5 per 100k residents CT Rhode Island: no data reported RI Arizona: 5,425 units · 73.0 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: 3,447 units · 112 per 100k residents AR Tennessee: 2,681 units · 37.6 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 109,080 units · 358 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
37.64,184
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
🏆 Top states by units · per 100k residents
1 Kentucky 4,184 /100k
2 New York 3,223 /100k
3 Ohio 666 /100k
4 Oregon 462 /100k
5 Texas 358 /100k
6 Massachusetts 283 /100k
7 Nebraska 262 /100k
8 Pennsylvania 260 /100k
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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
72 tubes this page00536-1316-25 17,170 Rx · $153,958
72 tubes00536-1316-28 12,770 Rx · $97,610
12 jars00536-1316-98 9,426 Rx · $95,277
Drug total (last 4 qtrs): 39,366 Rx · 4,144,903 units · $346,846 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00536-1316-25 You're viewing this 72 TUBE in 1 CASE (0536-1316-25) / 60 g in 1 TUBE $0.0585 / g $252.76 2021-03-01 Active
00536-1316-28 72 TUBE in 1 CASE (0536-1316-28) / 30 g in 1 TUBE $0.0786 / g $169.86 2021-03-01 Active
00536-1316-98 12 JAR in 1 CASE (0536-1316-98) / 454 g in 1 JAR $0.0155 / g $84.50 2021-03-01 Active

Per g, this pack runs about 277% above the cheapest pack (NDC 00536-1316-98, $0.0155 vs $0.0585 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 44% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00536-1316-25?
NDC 00536-1316-25 is listed by the FDA — 72 tube in 1 case / 60 g in 1 tube.
What NDC number is used to bill for this package of Rugby Zinc Oxide 20% 20 g/100g Ointment?
Bill NDC 00536-1316-25 — the 11-digit billing format is 00536131625. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 15 words

Uses • Dries the oozing and weeping of poison: • Ivy • Oak • Sumac

⏱️ Dosage and Administration 10 words

Directions For poison ivy, oak, and sumac: apply as needed.

⚠️ Warnings 83 words

Warnings For External Use Only When using this product • Do not get into eyes • Do not use over large areas of the body Stop use and ask a doctor if • The condition worsens • Symptoms last more than 7 days or clear up and occur again within a few days • If you are allergic to any of these ingredients Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

🧪 Active Ingredient 6 words

Active Ingredient Zinc Oxide 20% w/w

🧪 Inactive Ingredients 13 words

Inactive Ingredients Cetomacrogol 1000, Cetostearyl Alcohol, Light Mineral Oil, White Soft Paraffin (Petrolatum)

🎯 Purpose 3 words

Purpose Skin Protectant

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.