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Strong Iodine Solution 700 mg/mL; 1400 mg/mL Solution/ Drops, 14 mL — NDC 48433-0230-15 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Strong Iodine Solution 700 mg/mL; 1400 mg/mL Solution/ Drops, 14 mL — NDC 48433-230-15 (Billing 48433-0230-15)

by Safecor Health, LLC · 14 mL in 1 BOTTLE

This is a package of 14 mL of Strong Iodine Solution 700 mg/mL; 1400 mg/mL Solution/ Drops from Safecor Health, LLC, marketed since Sep 2008 and currently FDA-listed. It is this product's only package size.

NDC 48433-0230-15
🏷️ FDA NDC (as labeled) 48433-230-15 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ 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 →

This page is curated, coded, and maintained by

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

Past resolved recalls for this product (1)
Class II · Oct 19, 2023 · Terminated — CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements. (Safecor Health, LLC) · FDA recall D-0082-2024

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 48433-230-15
Product NDC 48433-230
11-digit billing NDC 48433023015
NCPDP billing unit ML — per mL (volume)
RxCUI 204913
UNII 9679TC07X4, 1C4QK22F9J
UPC 0348433230152
SPL Set ID ec12b0ab-8fee-4b4f-a6e7-349f60a6f3e0
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2008-09-20
Route ORAL
Dosage form SOLUTION/ DROPS
Substance IODINE; POTASSIUM IODIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 79350032002020
GPI class Iodine Strong
GCN Seq No 001674
GCN 61140
HICL code 000747
Ingredient (HICL) Potassium Iodide/Iodine
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C3
Therapeutic class — intermediate (HIC2) Minerals
HIC3 code C3H
Therapeutic class — specific (HIC3) Iodine Containing Agents
AHFS code 08:14.92.00
AHFS class Antifungals, Miscellaneous
FDB label name STRONG IODINE SOLUTION
FDB brand name Strong Iodine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 001674
  • GCN: 61140
  • GPI-14 (Medi-Span): 79350032002020
  • HICL (First Databank): 000747
  • AHFS class code: 08:14.92.00
  • RxCUI (RxNorm): 204913
Why two NDCs? The FDA registers this code as 48433-230-15 — 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 → 48433-0230-15. 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 Iodine products class.

Drug family (ATC) Iodine products
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.

Clinical

Label name STRONG IODINE SOLUTION Ingredient Potassium Iodide/Iodine
🧪 What is this product?

Strong Iodine Solution is an oral liquid drop product containing iodine and potassium iodide. These ingredients are typically used to provide iodine supplementation and to help protect the thyroid gland from radioactive iodine exposure in certain emergency situations. This product is marketed without an approved FDA application. Iodine is an essential mineral needed for normal thyroid function and metabolism.

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.

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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
48433-0230-15 You're viewing this Main listing 14 mL in 1 BOTTLE 2008-09-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Iodine and potassium iodide 50 mg/mL; 100 mg/mL 00395-2775-16 Humco 473 ml — — FDA listed —
Lugols Solution Strong Iodine Solution 1 g/g 38779-0598-05 Medisca 5 g — — FDA listed —
Strong Iodine Solution 700 mg/mL; 1400 mg/mLthis 48433-0230-15 Safecor 14 ml — — 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

🏛️
2008
On the market since
Sep 2008
📍
2026
Currently FDA-listed
18 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.

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.

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.

Manufacturer & labeler

LabelerSafecor Health, LLC
Labeler code48433
First marketedSep 2008
Product typeHuman Prescription Drug
Portfolio55 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 101 words ▾

INDICATIONS Strong Iodine Solution, containing 5 percent of iodine and 10 percent of potassium iodide, is employed in the prophylaxis of simple and colloid goiters and in the treatment of exophthalmic goiter. It can be used alone as a preoperative preparation but is now most commonly used concomitantly with propylthiouracil and other antithyroid drugs. When used with these drugs, Strong Iodine Solution produces involution of the hyperplastic gland thus making a less triable and vascular gland for thyroidectomy.

In addition, it has an additive antithyroid action that helps make the patient enthyroid faster than if the antithyroid drugs were used alone.

⏱️ Dosage and Administration 53 words ▾

DOSAGE Strong Iodine Solution is for oral use only. The usual dosage of Strong Iodine Solution is 2 to 6 drops (0.1 to 0.3 ml) three times daily taken in water after meals for two or three weeks prior to operation. In thyroid crisis the dosage is 1 ml three times a day.

⛔ Contraindications 61 words ▾

CONTRAINDICATIONS The use of iodides may be contraindicated in patients with tuberculosis because it is believed they may cause a breakdown of healing lesions. The use of iodides is contraindicated in patients with iododerma, laryngeal edema, and swelling of salivary glands or increased salivation upon previous exposure to iodides. Strong Iodine Solution is ineffective in the treatment of postoperative thyroid crisis.

⚠️ Warnings 25 words ▾

WARNINGS Prolonged therapy may cause iodism. USE IN PREGNANCY: The drug readily crosses the placental barrier and may affect the fetus if used during pregnancy.

🤒 Adverse Reactions 24 words ▾

ADVERSE REACTIONS Ingestion of large quantities of Strong Iodine Solution may cause abdominal pain, nausea, vomiting and diarrhea. Average doses may cause skin rash.

📦 How Supplied / Storage and Handling 44 words ▾

HOW SUPPLIED Bottles of 14 ml, amber glass with lined plastic closures. Accompanying each bottle is a glass dropper which should be used when the solution is ready to be dispensed to minimize any loss of free iodine through the bulb of the dropper.

📦 Storage and Handling 5 words ▾

STORAGE Store at room temperature

📋 Description 14 words ▾

DESCRIPTION Iodine 5g, potassium iodide 10g, in enough purified water to make 100 ml.

⚠️ Precautions 65 words ▾

PRECAUTIONS Iodine therapy does not completely control the manifestations of hyperthyroidism and after a variable period of time, the beneficial effects wear off. With continued administration of the drug, the hyperthyroidism may return in its initial intensity or become even more severe than it was at first. Measurements of the protein-bound iodine or of the uptake of radioiodine are rendered useless if iodine is given.

📄 Package Label / Principal Display Panel 26 words ▾

———Principal Display Panel——— Do Not Use in Eyes NDC 48433-230-15 Rx only SAFECOR HEALTH Strong Iodine Solution U.S.P. (Lugol's Solution) NET CONTENTS 14 mL Product Label

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

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 "Unapproved Drug Other". 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 Safecor Health, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Safecor Health, 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 48433-0226-40 · Safecor 48546-0001-01 · Indiana →
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.