First Aid Antiseptic POVIDONE-IODINE 100 mg/g Ointment, 1 tube
by Rugby Laboratories · 1 TUBE in 1 BOX (0536-1271-80) / 28.4 g in 1 TUBE
NDC 00536-1271-80
🏷️ FDA NDC (as labeled)
0536-1271-80
billing pads the labeler segment with a zero
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 →
🚨
Active recall for this product.
Class II · Sep 11, 2024 — Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000. (Zhejiang Jingwei Pharmaceutical Co., Ltd.) · FDA recall D-0013-2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Povidone-iodine (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Aug 19, 2025 — Subpotent drug (Medline Industries, LP) · FDA recall D-0674-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
🆔 Identity & classification
FDA NDC (as labeled)
0536-1271-80
Product NDC
0536-1271
11-digit billing NDC
00536127180
NCPDP billing unit
GM — per gram (weight)
RxCUI
312563
UNII
85H0HZU99M
UPC
0305361271800
Application #
M003
SPL Set ID
b2bcb69e-8ffb-23ee-e053-2995a90aee21
Established class (EPC)
Antiseptic
Chemical class
Iodine
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2020-11-03
Route
TOPICAL
Dosage form
OINTMENT
Substance
POVIDONE-IODINE
GPI-14
92200040004210
GPI class
First Aid Antiseptic
GCN Seq No
007225
GCN
29761
HICL code
004265
Ingredient (HICL)
Povidone-Iodine
HIC1 code
Q
Therapeutic class — broad (HIC1)
Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code
Q5
Therapeutic class — intermediate (HIC2)
Agents Acting Principally On The Skin
HIC3 code
Q5B
Therapeutic class — specific (HIC3)
Topical Preparations,Antibacterials
AHFS code
84:04.92.00
AHFS class
Local Anti-Infectives, Miscellaneous
FDB label name
FIRST AID ANTISEPTIC 10% OINT
FDB brand name
First Aid Antiseptic
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 0536-1271-80 — 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 → 00536-1271-80. 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.
🏷️ RxNorm drug class
This medicine belongs to the Antiseptic class.
Pharmacologic class
Antiseptic
Drug family (ATC)
Iodine products, Medicated dressings with antiinfectives, Medicated shampoos
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
🏭 Manufacturer & labeler
LabelerRugby Laboratories
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code00536
First marketedNov 2020
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 FIRST AID ANTISEPTIC 10% OINT Ingredient Povidone-Iodine
📗 Our plain-language guide HelloPharmacist
- Povidone-iodine is an antiseptic — it kills bacteria on the skin. You'll find it in a lot of different products: surgical scrubs, skin prep solutions and swabs used before procedur...
- What is povidone-iodine actually used for?
- The standard topical products are for external skin use only — keep them away from your eyes, ears, and mouth. That said, the 3M Skin and Nasal Antiseptic is specifically labeled f...
- For first-aid use at home, you should not use povidone-iodine on a wound for more than 7 days unless a doctor or dentist tells you it's okay. If your wound isn't improving after a...
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.
💬 Questions about POVIDONE-IODINE?
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 B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
-
UNII 4R4HFI6D95
Polyethylene glycol 4000 is a synthetic polymer derived from petroleum. It serves as a binder, filler, and lubricant in solid dosage forms, and helps control how quickly the medicine dissolves.
2 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesPolyethylene Glycol 400, Polyethylene Glycol 4000
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 | $0.054 | $1.54 / 28.4 g |
| Medicaid paysCMS SDUD · 12 mo | $2.51 | $71.16 / 28.4 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
▲ Up 11% over the last 6 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| First Aid Antiseptic 100 mg/gthis 00536-1271-80 | Rugby | 1 tube | $0.054 | — | Availability likely | — |
| MediChoice Povidone-Iodine 100 mg/g 39892-0820-01 | O&M | 1 g | — | — | FDA listed | — |
| DermaWound Wound Care 10 g/100g 57554-0110-06 | Progressive | 1 tube | — | — | FDA listed | — |
| Maokang 10 Povidone Iodine 100 mg/g 59050-0269-00 | Changzhou | 1 g | — | — | FDA listed | — |
| Povidone Iodine 100 mg/g 69396-0112-20 | Trifecta | 1 tube | — | — | FDA listed | — |
| TM Titus Medical Povidone Iodine 1 g/100g 81526-0002-01 | Titus | 100 pouches | — | — | FDA listed | — |
| Povidone Iodine 100 mg/g 81584-1102-01 | Dr | 1 tube | — | — | FDA listed | — |
| Povidone-Iodine Prep Sterile 100 mg/g 59050-0658-11 | Changzhou | 20 patches | — | — | FDA listed | — |
| Povidone-Iodine Prep Sterile 100 mg/g 63517-0251-21 | Cardinal | 50 patches | — | — | FDA listed | — |
| Povidone-Iodine Prep Sterile 100 mg/g 63517-0254-21 | Cardinal | 4.5 g | — | — | FDA listed | — |
| Povidone-Iodine Prep Sterile 100 mg/g 63517-0658-11 | Cardinal | 80 g | — | — | FDA listed | — |
| Povidone-Iodine Prep Winged Sterile Small 100 mg/g 63517-0751-11 | Cardinal | 100 g | — | — | FDA listed | — |
| Povidone-Iodine Prep Winged Sterile Large 100 mg/g 63517-0759-11 | Cardinal | 10 pouches | — | — | FDA listed | — |
| Povidone Iodine Swabsticks 4 Triple 100 mg/g 72838-0360-01 | Amsino | 3 applicators | — | — | FDA listed | — |
| Antiseptic Povidone Iodine Prep Pad 100 mg/g 84219-0006-00 | M-star | 1 patch | — | — | FDA listed | — |
| Povidone Iodine Prep 100 mg/g 34645-5506-00 | Jianerkang | 500 pouches | — | — | 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
🏛️
2020
On the market since
Nov 2020
📍
2026
Currently FDA-listed
6 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 00536-1271-80, 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
16
Units reimbursed last 4 qtrs
12
Gross reimbursed last 4 qtrs
$30.07
Avg / prescription
$1.88
Avg / unit
$2.5058
Latest quarter Q4 2025
0Rx
Medicaid pays / g
$2.5058
gross reimbursed
vs
NADAC / g
$0.0544
acquisition cost
=
Spread
+$2.4514
+4506% 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 · 16 Rx
State Medicaid map
Units reimbursed · per 100k residents
0.30.3
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.
📊 Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)
Medicare Part D (outpatient prescription) spending for Betadine (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Betadine. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$874.18
Claims incl. refills
38
Beneficiaries
28
Spend / beneficiary
$31.22
Spend / claim
$23.00
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
🔬 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 First Aid Antiseptic (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 34%
Female · 66%
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 |
|---|---|---|---|
| 00536-1271-80 You're viewing this | 1 TUBE in 1 BOX (0536-1271-80) / 28.4 g in 1 TUBE | 2020-11-03 | Active |
📄 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
🎯 Indications and Usage ▾
Uses first aid to help prevent infection in minor: cuts scrapes burns
⏱️ Dosage and Administration ▾
Directions clean the affected area apply a small amount of this product on the area 1 to 3 times daily may be covered with a sterile bandage
⚠️ Warnings ▾
Warnings For external use only. Do not use if you are allergic to any of the ingredients over large areas of the body longer than 1 week unless directed by a doctor in the eyes Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if condition persists or gets worse 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 ▾
Active ingredient Povidone Iodine USP 10% w/w (available iodine 1%) Purpose First aid antiseptic
🧪 Inactive Ingredients ▾
Inactive ingredients Polyethylene Glycol 400, Polyethylene Glycol 4000
🎯 Purpose ▾
Purpose First aid antiseptic
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.