FDA.reportPublic FDA data

Thyroid

Manufacturer
ProBlen
Effective date
2020-09-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:13:19

Label at a glance#

ProductThyroid
Active ingredientFERROUS IODIDE, POTASSIUM IODIDE, SPONGIA OFFICINALIS SKELETON, ROASTED, FUCUS VESICULOSUS, THYROID, UNSPECIFIED, SUS SCROFA ADRENAL GLAND, SUS SCROFA PITUITARY GLAND, CALCIUM HEXAFLUOROSILICATE, HYDROFLUORIC ACID, CALCIUM IODIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (HPUS*) equal amounts of:

Calcarea Iodata 12X, Ferrum Iodatum 12X, Kali Iodatum 6X, Spongia Tosta 6X, Fucus Vesiculosus 3X, Thyroidinum 6X, Glandula Suprarenalis 6X, Hypophysis 6X, Lapis Albus 30X, Hydrofluoricum Acidum 12C.

* The letters HPUS indicate this indredient is officially included in the Homeopathic Pharmacopoeia of the United States.

** Claims based on traditional homeopathic practices, not accepted medical evidence. Not FDA evaluated.

INDICATIONS & USAGE SECTION

Indications: Temporarily supports the body to rebalance thyroid output. Symptoms of imbalanced thyroid output. Symptoms of imbalanced thyroid may include: poor muscle/fat balance, dry wrinkled-looking skin, low energy, weak immune system, depression.**

WARNINGS SECTION

Warnings: Not for use on children. If symptoms continue to recur, or if sleeplessness persists continously for more than two weeks, consult a physician. Insomnia may be a symptom of a serious underlying medical illness. As with all medicines, if you are pregnant or breast feeding, consult a health professional before using this product. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions: Adults: Hold the spray-top close to your open mouth and spray twice directly under your tongue, three times a day. Some people notice improvements within three weeks, others take longer.

OTHER SAFETY INFORMATION

Tamper Evident: There is a seal around the entire bottle. Do not use if this seal is broken or missing.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Organic Ethanol, Purified Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 43853-0024-1

Thy

roid

HOMEOPATHIC

ORGANOTHERAPY

1.0 FL OZ 20% ETHANOL

prOBLEN

1 fl. oz. bottle label1 fl. oz. bottle label

OTC - PURPOSE SECTION

Temporarily supports the body to rebalance thyroid output. Symptoms of imbalanced thyroid output. Symptoms of imbalanced thyroid may include: poor muscle/fat balance, dry wrinkled-looking skin, low energy, weak immune system, depression.**

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43853-0024-12022-01-28C16284748780-1d6a99b39-61e9-a426-e053-dadaa90af4c2Thyroid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43853-0024-1Thyroid30 mL in 1 BOTTLESPRAY301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43853-0024THYROID (CALCAREA IODATA, FERRUM IODATUM, KALI IODATUM, SPONGIA TOSTA, FUCUS VESICULOSUS, THYROIDINUM, GLANDULA SUPRARENALIS, HYPOPHYSIS, LAPIS ALBUS, HYDROFLUORICUM ACIDUM) SPRAY [PROBLEN]1Legacy NDC, 1 package rows20200929_d2767723-a0a1-4b63-94ad-eee4ca288d4f.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43853-002443853-0024-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERROUS IODIDEF5452U54PNACTIB
POTASSIUM IODIDE1C4QK22F9JACTIB
SPONGIA OFFICINALIS SKELETON, ROASTED1PIP394IIDACTIB
FUCUS VESICULOSUS535G2ABX9MACTIB
THYROID, UNSPECIFIED0B4FDL9I6PACTIB
SUS SCROFA ADRENAL GLAND398IYQ16YVACTIB
SUS SCROFA PITUITARY GLANDL0PFEMQ1DTACTIB
CALCIUM HEXAFLUOROSILICATE2NVP93XVQ3ACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
HYDROFLUORIC ACIDRGL5YE86CZACTIM
CALCIUM IODIDE8EKI9QEE2HACTIB

Source Document#

Source XML

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
e159d2ac-7f87-422b-8b3a-9dd2c8e01d8ed2767723-a0a1-4b63-94ad-eee4ca288d4f2020-09-28WarningsExact identifier
spl id: e159d2ac-7f87-422b-8b3a-9dd2c8e01d8e
spl set id: d2767723-a0a1-4b63-94ad-eee4ca288d4f

Reported adverse events (FAERS/openFDA)#

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