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POTASSIUM IODIDE 65 mg/mL Solution

by Mission Pharmacal Company · 1 BOTTLE, DROPPER in 1 CARTON (0178-0314-30) / 30 mL in 1 BOTTLE, DROPPER
NDC 00178-0314-30
🏷️ FDA NDC (as labeled) 0178-0314-30 billing pads the labeler segment with a zero
OTC Generic 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 →

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) 0178-0314-30
Product NDC 0178-0314
11-digit billing NDC 00178031430
NCPDP billing unit ML — per mL (volume)
RxCUI 242429
UNII 1C4QK22F9J
Application # ANDA206211
SPL Set ID d9e02a48-8129-9076-78b2-db01750bd220
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-05-15
Route ORAL
Dosage form SOLUTION
Substance POTASSIUM IODIDE
GPI-14 93000065102020
GPI class Potassium Iodide (Antidote)
GCN Seq No 036443
GCN 95857
HICL code 000748
Ingredient (HICL) Potassium Iodide
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 POTASSIUM IODIDE 65 MG/ML SOLN
FDB brand name Potassium Iodide
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0178-0314-30 — 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 → 00178-0314-30. 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 Expectorants class.

Drug family (ATC) Expectorants, Other ophthalmologicals, Antidotes
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

LabelerMission Pharmacal Company
Application holderMISSION PHARMACAL CO
FDA applicationANDA206211 (ANDA)
Labeler code00178
First marketedMay 2016
Product typeHuman Otc Drug
Portfolio26 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 POTASSIUM IODIDE 65 MG/ML SOLN Ingredient Potassium Iodide
📖 What it is MedlinePlus · NLM

Potassium iodide is used to protect the thyroid gland from taking in radioactive iodine that may be released during a nuclear radiation emergency. Radioactive iodine can damage the thyroid gland. You should only take potassium iodide if there is a nuclear radiation emergency and public officials tell you that you should take it. Potassium iodide is in a class of medications called anti-thyroid medications. It works by blocking radioactive iodine from entering the thyroid gland. Potassium iodide can protect you from the effects of radioactive iodine that may be released during a nuclear radiati...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's reasonable to have it on hand if public health authorities in your area recommend it — especially if you live near a nuclear facility. But the key rule is: only take it when p...
  • Should I keep potassium iodide at home just in case, or only take it if there's actually an emergency?
  • No — taking more than one dose every 24 hours will not give you more protection. Your thyroid can only hold a certain amount of iodine at a time, so once it's full, extra doses jus...
  • What if I take an extra dose? Will it protect me better?
📖 Read our full Potassium Iodide guide →
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 2DQE8SE78C
    Black raspberry is a natural plant extract from dark berries used as a colorant and flavoring agent in medicines. It gives products their dark color and adds berry taste.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 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.

9 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesInactive ingredients FD&C Red #40 and Blue #1, methylparaben, natural and artificial black raspberry flavor, propylene glycol, propylparaben, purified water (USP), sodium saccharin, sucrose FD&C Red #40 and Blue #1, methylparaben, natural and artificial black raspberry flavor, propylene glycol, propylparaben, purified water (USP), sodium saccharin, sucrose.

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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Potassium Iodide 65 mg/mLthis 00178-0314-30 Mission 1 bottle — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2016
On the market since
May 2016
📍
2026
Currently FDA-listed
10 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🔬 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 POTASSIUM IODIDE — the ingredient across all brands.

Top reported reactions

Diarrhoea311
Fatigue288
Dyspnoea277
Headache277
Nausea272
Dizziness265
Fall261

Age at onset

Neonate21
Infant2
Child4
Adolescent6
Adult122
Elderly398

Reporter sex

2,101 reports
Male · 34%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization669
Death417
Life-threatening135
Disabling66
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 189 0
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 NDCDescription Marketing startStatus
00178-0314-30 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON (0178-0314-30) / 30 mL in 1 BOTTLE, DROPPER 2016-05-15 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
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 — Not published for this NDC No photo available yet for this listing.
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

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 FDA registers it as 0178-0314-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00178-0314-30, written without dashes as 00178031430. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00178-0314-30, the first segment (00178) is the labeler code FDA assigned to Mission Pharmacal Company; the middle segment (0314) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Mission Pharmacal Company. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Mission Pharmacal Company 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.

📄 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 📦 How Supplied / Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📋 Description
🎯 Indications and Usage 45 words ▾

Use Helps prevent radioactive iodine from getting into the thyroid gland during a nuclear radiation emergency. Use along with other emergency measures recommended by public officials.

INDICATIONS: Potassium Iodide Oral Solution is a thyroid blocking medicine that is used in a nuclear radiation emergency only.

⏱️ Dosage and Administration ~1 min read ▾

Directions use as directed by public officials in the event of a nuclear radiation emergency. do not take more than 1 dose in 24 hours. Dosing Chart (dropper inside) Adults over 18 years 2 mL every day (130 mg) and Children over 12 years to 18 years who weigh at least 150 pounds 2 mL every day (130 mg) Children over 12 years to 18 years who weigh less than 150 pounds 1 mL every day (65 mg) and Children over 3 years to 12 years 1 mL every day (65 mg) Children over 1 month to 3 years 0.5 mL every day (32.5 mg) Babies at birth to 1 month 0.25 mL every day (16.25 mg) Dropper 2mL Dropper 1mL Dropper 0.5mL Dropper 0.25 mL

DIRECTIONS FOR USE: Use only as directed by public officials if a nuclear radiation emergency happens. Dose: Adults over 18 years 2 mL every day (130 mg) Children over 12 years to 18 years 2 mL every day (130 mg) who weigh at least 150 pounds Children over 12 years to 18 years 1 mL every day (65 mg) who weigh less than 150 pounds Children over 3 years to 12 years 1 mL every day (65 mg) Children over 1 month to 3 years 0.5 mL every day (32.5 mg) Babies at birth to 1 month 0.25 mL every day (16.25 mg) Take KI every day (every 24 hours) as directed by public officials.

Do not take more than 1 dose in 24 hours. More will not help you. Too much medicine may increase the chances of side effects.

Dropper 2mL Dropper 1mL Dropper 0.5mL Dropper 0.25mL

⚠️ Warnings 213 words ▾

Warnings Allergy alert: Iodine may cause an allergic reaction with 1 or more of the following symptoms: shortness of breath or wheezing skin rash trouble breathing, speaking or swallowing swelling fever and joint pain Do not use if you have ever had an allergic reaction to iodine nodular thyroid disease with heart disease hypocomplementemic vasculitis dermatitis herpetiformis Stop use and ask a doctor if you have an allergic reaction. Get medical help right away if you have trouble breathing, speaking or swallowing; shortness of breath; wheezing; swelling of the mouth, tongue or throat; or rash. irregular heart or chest pain.

Get medical help right away. swelling of the hands or feet, fever, or joint pain. Keep Out of Reach of Children. In case of overdose, get medical help or contact a Poison Control Center right away.

WARNING: People who are allergic to iodine, have dermatitis herpetiformis or hypocomplementemic vasculitis, or have nodular thyroid disease with heart disease should not take KI. Keep out of the reach of children. In case of an allergic reaction (difficulty breathing, speaking or swallowing; wheezing; shortness of breath or swelling of the mouth or throat), call 911 or get medical care right away.

In case of overdose, get medical help or call a Poison Control Center right away.

📦 How Supplied / Storage and Handling 87 words ▾

Other Information store at 25°C (77°F). Excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature. keep container tightly closed keep in carton protected from light do not throw away consumer package insert

HOW SUPPLIED: Potassium Iodide Oral Solution is supplied in 1 oz (30 mL) bottles. Each mL contains 65 mg potassium iodide. Store at 25°C (77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Keep container tightly closed and in carton, protected from light. MISSION PHARMACAL COMPANY San Antonio, TX 78230 1355 I0314R0919

🧪 Active Ingredient 7 words ▾

Active Ingredient Potassium iodide (USP) 65 mg

🧪 Inactive Ingredients 48 words ▾

Inactive ingredients FD&C Red #40 and Blue #1, methylparaben, natural and artificial black raspberry flavor, propylene glycol, propylparaben, purified water (USP), sodium saccharin, sucrose

INACTIVE INGREDIENTS: FD&C Red #40 and Blue #1, methylparaben, natural and artificial black raspberry flavor, propylene glycol, propylparaben, purified water (USP), sodium saccharin, sucrose.

🎯 Purpose 108 words ▾

Purpose Thyroid blocking

HOW POTASSIUM IODIDE WORKS: Certain forms of iodine help your thyroid gland work right. Most people get the iodine they need from foods like iodized salt or fish. The thyroid can “store” or hold only a certain amount of iodine.

In a nuclear radiation emergency, radioactive iodine may be released in the air. This material may be breathed or swallowed. It may enter the thyroid gland and damage it.

The damage would probably not show itself for years. Children are most likely to have thyroid damage. If you take KI, it will block or reduce the chances that radioactive iodine will enter your thyroid gland.

📋 Description 47 words ▾

DESCRIPTION: Each milliliter (1 mL) of Potassium Iodide Oral Solution contains 65 mg of potassium iodide (USP) in a black raspberry-flavored solution. Inactive ingredients are: FD&C Red #40 and Blue #1, methylparaben, natural and artificial black raspberry flavor, propylene glycol, propylparaben, purified water (USP), sodium saccharin, sucrose.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00178-0089-90 · Mission 00178-0320-03 · Mission →
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.