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Sunmark Iodine IODINE, SODIUM IODIDE, ALCOHOL 20 mg/mL; 470 mg/mL; 24 mg/mL Tincture, 30 mL — NDC 49348-0133-27 package photo

Sunmark Iodine IODINE, SODIUM IODIDE, ALCOHOL 20 mg/mL; 470 mg/mL; 24 mg/mL Tincture, 30 mL

by Strategic Sourcing Services LLC · 30 mL in 1 BOTTLE (49348-133-27)
NDC 49348-0133-27
🏷️ FDA NDC (as labeled) 49348-133-27 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 49348-133-27
Product NDC 49348-133
11-digit billing NDC 49348013327
NCPDP billing unit ML — per mL (volume)
UNII 9679TC07X4, 3K9958V90M, F5WR8N145C
UPC 0010939157331
Application # M003
SPL Set ID e8dae2d6-58b1-4c4e-a4c1-371db055b7ae
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-06-28
Route TOPICAL
Dosage form TINCTURE
Substance IODINE; ALCOHOL; SODIUM IODIDE
GPI-14 92200020001510
GPI class SM Iodine Tincture
GCN Seq No 062671
GCN 98445
HICL code 005095
Ingredient (HICL) Iodine/Sodium Iodide
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 84:04.16.00
AHFS class Astringents, Anti-Infective
FDB label name SM IODINE 2% TINCTURE
FDB brand name Iodine
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 49348-133-27 — 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 → 49348-0133-27. 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

LabelerStrategic Sourcing Services LLC
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code49348
First marketedJun 2012
Product typeHuman Otc Drug
Portfolio316 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 SM IODINE 2% TINCTURE Ingredient Iodine/Sodium Iodide
🧪 What is this product?

Sunmark Iodine is a topical tincture that combines iodine and sodium iodide with alcohol as a solvent. This product is an OTC monograph drug, meaning it is marketed under FDA's established rules for antiseptic and germicide products rather than through individual brand approval. Iodine compounds in this form are typically used as a topical antiseptic to help reduce bacteria and germs on the skin before medical procedures or minor cuts and scrapes.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

🧪 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 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesPurified Water.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.072 $2.16 / 30 ml
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.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Apr 2022 Aug 2022 Jan 2024 $0.079 $0.066
▲ Up 9% over the last 12 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
Sunmark Iodine 20 mg/mL; 470 mg/mL; 24 mg/mLthis 49348-0133-27 Strategic 30 ml $0.072 — FDA listed —
Foster and Thrive 2% Mild Iodine Tincture 24 mg/mL; 20 mg/mL 70677-1204-01 Strategic 30 ml $0.073 — Availability likely +2%
Iodine 20 mg/mL 00363-0088-10 Walgreen 30 ml — — FDA listed —
Iodine 20 mg/mL 11344-0880-10 Nice-Pak 30 ml — — FDA listed —
Iodine Tincture 20 mg/mL 30142-0088-10 The 30 ml — — FDA listed —
Iodine 20 mg/mL 41163-0088-10 United 30 ml — — FDA listed —
mild iodine tincture 20 mg/mL; 470 mg/mL; 20.4 mg/mL 59450-0030-36 KROGER 30 ml — — FDA listed —
Salicylic Iodine (Iodo Salicilico) First Aid Antiseptic 20 mg/mL 73635-1220-01 Germa 30 ml — — FDA listed —
Iodine Tincture (IODO) First Aid Antiseptic 20 mg/mL 73635-1221-01 Germa 30 ml — — FDA listed —
Iodo Blanco (Iodine Tincture Decolorized) First Aid Antiseptic 20 mg/mL 73635-1222-01 Germa 30 ml — — FDA listed —
Iodine Tincture 20 mg/mL 76162-0088-10 Topco 30 ml — — FDA listed —
Ioddo Iodine .56 g/28g 84178-0005-03 EVI 28 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

🏛️
2012
On the market since
Jun 2012
📍
2026
Currently FDA-listed
14 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
49348-0133-27 You're viewing this 30 mL in 1 BOTTLE (49348-133-27) 2019-08-23 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 11 words ▾

Uses To help prevent infection in minor cuts, scrapes and burns.

⏱️ Dosage and Administration 30 words ▾

DIRECTIONS: Clean the affected area. Apply a small amount to the affected area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

⚠️ Warnings 5 words ▾

WARNINGS: For external use only.

🧪 Active Ingredient 9 words ▾

Active Ingredients Iodine 2%, Sodium Iodide 2.4%, Alcohol 47%

🧪 Inactive Ingredients 4 words ▾

Inactive ingredient: Purified Water.

🎯 Purpose 2 words ▾

Purpose Antiseptic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 49348-0095-29 · Strategic 49348-0138-30 · Strategic →
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.