ThyroShield - potassium iodide oral solution

Manufacturer
Arco Pharmaceuticals LLC
Effective date
2014-09-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:40:18

Label at a glance#

ProductThyroShield
Active ingredientPOTASSIUM IODIDE
Label structure18 sections

Indications and uses

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.

Dosage and administration

• 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...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Potassium iodide (USP) 65 mg

Purpose

OTC - PURPOSE SECTION

Thyroid blocking

Uses

INDICATIONS & USAGE SECTION

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.

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • an allergic reaction to iodine
  • nodular thyroid disease with heart disease
  • hypocomplementemic vasculitis
  • dermatitis herpetiformis

Stop use and ask a doctor if you have

OTC - STOP USE SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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)

Adult Dose
Adult Dose

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 12-18
Children 12-18

Children over 1 month to 3 years
0.5 mL every day (32.5 mg)

Children 1-month - 3 years
Children 1-month - 3 years

Babies at birth to 1 month
0.25 mL every day (16.25 mg)

babies to 1 month
babies to 1 month

If pregnant, breastfeeding, have a baby up to 1 month of age or have thyroid disease (except nodular thyroid disease with heart disease), take as directed above and contact a doctor as soon as possible.

Other Information

SPL UNCLASSIFIED SECTION

  • 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or Comments?

OTC - QUESTIONS SECTION

call toll free 1-800-343-0164

Patient Information

SPL UNCLASSIFIED SECTION

ThyroShield®

(Potassium Iodide Oral Solution, 1 mL = 65 mg)

(Abbreviated KI)

Take potassium iodide (KI) only when public officials tell you. In a nuclear radiation emergency, radioactive iodine could be released into the air. KI protects only the thyroid gland from uptake of radioactive iodine. Therefore, KI should be used along with other emergency measures that will be recommended to you by public officials.

If you are told to take this medicine, take it one time every 24 hours. Do not take it more often. More KI will not help you. Too much KI may increase the chances of side effects. Do not take this medicine if you know you are allergic to iodine (see SIDE EFFECTS below).

DESCRIPTION:

DESCRIPTION SECTION

Each milliliter (1 mL) of ThyroShield® 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.

INDICATIONS:

INDICATIONS & USAGE SECTION

ThyroShield® (Potassium Iodide Oral Solution) is a thyroid blocking medicine that is used in a nuclear radiation emergency only.

DIRECTIONS FOR USE:

SPL UNCLASSIFIED SECTION

Use only as directed by public officials if a nuclear radiation emergency happens.

Dose:

SPL UNCLASSIFIED SECTION

Adults over 18 years 2 mL every day (130 mg)

Children over 12 years to 18 years 2 mL every day (130 mg)adult doseadult dose

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 12 to 18children 12 to 18

Children over 1 month to 3 years 0.5 mL every day (32.5 mg)children 1 month to 3 yearschildren 1 month to 3 years

Babies at birth to 1 month 0.25 mL every day (16.25 mg)babies to 1 monthbabies to 1 month

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.

Pregnant or breastfeeding women, or babies under 1 month of age: Take as directed above and call a doctor as soon as possible. Repeat dosing should be avoided. It is recommended that thyroid function be checked in babies less than 1 month of age that take KI. Women who are pregnant or breastfeeding should also be checked by a doctor if repeat dosing is necessary. Although these precautions should be taken, the benefits of short-term use of KI to block uptake of radioactive iodine by the thyroid gland far exceed its chances of side effects.

Patients with thyroid disease: If you have both a nodular thyroid condition such as multinodular goiter with heart disease, you should not take KI. Patients with other thyroid conditions may take KI as directed above, but call a doctor if you need to take KI for more than a few days.

WARNING:

WARNINGS SECTION

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 POTASSIUM IODIDE WORKS:

SPL UNCLASSIFIED SECTION

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 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.

WHO SHOULD NOT TAKE POTASSIUM IODIDE:

SPL UNCLASSIFIED SECTION

People should avoid KI if they are allergic to iodine, have dermatitis herpetiformis or hypocomplementemic vasculitis, or have nodular thyroid disease with heart disease, because these conditions may increase the chances of side effects to iodine.

HOW AND WHEN TO TAKE POTASSIUM IODIDE:

SPL UNCLASSIFIED SECTION

KI should be taken as soon as possible after public officials tell you. If you are told to repeat the dose, you should take the second dose 24 hours after the first dose. Do not take it sooner. More KI will not help you because the thyroid can “hold” only certain amounts of iodine. Taking more than 1 dose per day will increase the chances of side effects. The public officials will tell you how many days to take KI. You should take KI until the chances of major exposure to radioactive iodine by breathing or swallowing stops.

SIDE EFFECTS:

SPL UNCLASSIFIED SECTION

Short-term use of KI at the recommended dose is safe. You should not take this drug for longer than you are told.

Possible side effects include: swelling of the salivary glands, nausea, vomiting, diarrhea, stomach ache, fever, headache, metallic taste, and allergic reactions. Allergic reaction can include

  • skin rashes such as hives
  • swelling of various parts of the body such as the face, lips, tongue, throat, hands or feet
  • fever with joint pain
  • trouble breathing, speaking or swallowing
  • wheezing or shortness of breath

Get medical attention right away if you have trouble breathing, speaking or swallowing; wheezing; shortness of breath; or swelling of the mouth, tongue or throat.

Taking iodide, in rare cases, may cause overactivity of the thyroid gland, underactivity of the thyroid gland, or enlargement of the thyroid gland (goiter). Symptoms of an overactive thyroid gland may include an irregular heart beat and chest pain. Patients with thyroid disease are more likely to get these side effects. Babies under 1 month of age are more likely to get an underactive thyroid gland (hypothyroidism).

WHAT TO DO IF SIDE EFFECTS OCCUR:

SPL UNCLASSIFIED SECTION

Stop taking KI and call a doctor if you have one or more of the following symptoms:

SPL UNCLASSIFIED SECTION

  • swelling of the face, hands or feet
  • fever and joint pain
  • skin rash

Stop taking KI and get medical help right away if you have one or more of the following symptoms:

SPL UNCLASSIFIED SECTION

  • trouble breathing, speaking or swallowing
  • shortness of breath or wheezing
  • swelling of the lips, tongue or throat
  • irregular heart beat or chest pain

You may report side effects to FDA at 1-800-FDA-1088

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

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

HOW SUPPLIED:

SPL UNCLASSIFIED SECTION

ThyroShield® (Potassium Iodide Oral Solution) is supplied in 1 oz (30 mL) bottles. Each mL contains 65 mg potassium iodide. Store at 25º C (77º F). Excursions permitted to 15-30º C (59-86º F). [See USP Controlled Room Temperature.] Keep container tightly closed and in carton, protected from light.

Manufactured for Arco Pharmaceuticals LLC, St. Louis, MO 63105

1-800-343-0164.

L240

Principal Display Panel - carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton Label
Carton Label

Principal Display Panel - bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle Label
Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
242429potassium iodide 325 MG in 5 mL Oral SolutionPSN1
723801ThyroShield 325 MG in 5 mL Oral SolutionPSN1
723801potassium iodide 65 MG/ML Oral Solution [ThyroShield]SBD1
242429potassium iodide 65 MG/ML Oral SolutionSCD1
242429K+ Iodide 65 MG/ML Oral SolutionSY1
723801K+ Iodide 65 MG/ML Oral Solution [ThyroShield]SY1
242429Pot Iodide 65 MG/ML Oral SolutionSY1
723801Pot Iodide 65 MG/ML Oral Solution [ThyroShield]SY1
242429potassium iodide 325 MG per 5 ML Oral SolutionSY1
723801ThyroShield 325 MG per 5 ML Oral SolutionSY1
723801ThyroShield 65 MG/ML Oral SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59465-210-012019-11-27C16284748780-19855e2a2-438c-60a7-e053-dbdaa90a05bdThyroShield - potassium iodide oral solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59465-210-01ThyroShield1 in 1 CARTONSOLUTION11
59465-210-01ThyroShield30 mL in 1 BOTTLE, DROPPERSOLUTION301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59465-210THYROSHIELD (POTASSIUM IODIDE) SOLUTION [ARCO PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20140926_186aadd3-2cb6-4de4-99b1-2371613e248d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POTASSIUM IODIDEACTIVE INGREDIENT1C4QK22F9J1
IODIDE IONACTIVE MOIETY09G4I6V86Q1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY1
SUCROSEINACTIVE INGREDIENTC151H8M5541
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59465-21059465-210-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 375 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / INTRAVENOUS0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
SUCROSESUCROSEC151H8M554WAFER / ORAL155.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii candidate
28 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / RESPIRATORY (INHALATION)0.03 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAPOWDER, FOR SUSPENSION / ORAL3 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET / SUBLINGUALNAExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / RECTAL0.01 %w/vExact identifier — unii candidate
37 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SUSPENSION / INTRAMUSCULAR1 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION, CONCENTRATE / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRAVENOUS95 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCAPSULE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, CHEWABLE / ORAL40 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii candidate
79 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET / ORAL43 mgExact identifier — unii candidate
34 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL18790 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / TOPICAL0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / SOFT TISSUE0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER, FOR SUSPENSION / ORAL40017 mgExact identifier — unii candidate
48 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
79 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION, EXTENDED RELEASE / ORAL5400 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRALESIONAL0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASYRUP / ORAL3 mgExact identifier — unii candidate
28 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / RECTAL90400 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE PELLETS / ORAL0.01 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
37 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TRANSDERMAL500 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / VAGINAL8 mgExact identifier — unii candidate
79 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SOLUTION / ORAL0.04 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPOWDER, FOR SOLUTION / ORAL13 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii candidate
79 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOAP / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / VAGINAL750 mgExact identifier — unii candidate
81 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / RECTAL271 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / IONTOPHORESIS0.1 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TEMULSION / TOPICAL0.2 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET / ORAL7 mgExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / VAGINAL3 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / PARENTERAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii candidate
81 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii candidate
34 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCAPSULE, EXTENDED RELEASE / ORAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION/ DROPS / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, LIQUID FILLED / ORAL0.08 mgExact identifier — unii candidate
37 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / INTRAMUSCULAR0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, FILM COATED / ORAL2.5 mgExact identifier — unii candidate
28 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, EXTENDED RELEASE / ORAL284.54 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION / INTRAVENOUS1950 mgExact identifier — unii candidate
48 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077218-001THYROSHIELDPOTASSIUM IODIDE65MG/MLSOLUTION / ORAL2005-01-12

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-1284e616aacf4f…
2026-08-18 06:07:402026-07A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077218-001THYROSHIELD65MG/MLSOLUTION / ORALRS2005-01-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077218-001THYROSHIELD65MG/MLSOLUTION / ORALRS2005-01-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A077218-001THYROSHIELD65MG/MLSOLUTION / ORALRS2005-01-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077218-001THYROSHIELD65MG/MLSOLUTION / ORALRS2005-01-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077218-001THYROSHIELD65MG/MLSOLUTION / ORALRS2005-01-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077218-001THYROSHIELD65MG/MLSOLUTION / ORALRS2005-01-123f01610625f2…
2019-09-15 20:21 UTC2019-09A077218-001THYROSHIELD65MG/MLSOLUTION / ORALRS2005-01-12b00525d2431f…
2019-07-19 19:46 UTC2019-07A077218-001THYROSHIELD65MG/MLSOLUTION / ORALRS2005-01-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-12ea1830bbd6c7…
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2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077218-001THYROSHIELD65MG/MLSOLUTION / ORAL2005-01-12f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
186aadd3-2cb6-4de4-99b1-2371613e248d186aadd3-2cb6-4de4-99b1-2371613e248d2014-09-22WarningsExact identifier
spl id: 186aadd3-2cb6-4de4-99b1-2371613e248d
spl set id: 186aadd3-2cb6-4de4-99b1-2371613e248d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.