FDA.reportPublic FDA data

DRUG FACTS:

Manufacturer
Institute for Wholistic Rejuvenation | Apotheca Company
Effective date
2026-10-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-10-13 04:02:18

Label at a glance#

ProductWholistic Thyroid Balance
Active ingredientFUCUS VESICULOSUS, SUS SCROFA THYROID, SPONGIA OFFICINALIS SKELETON, ROASTED
Label structure9 sections

Dosage and administration

1 drop under tongue or as directed by a health practitioner. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Fucus Vesiculosus 3X, Thyroidinum 6X, 30C, Spongia Tosta 12X.

INDICATIONS:

OTC - PURPOSE SECTION

Formulated for symptoms such as sluggish metabolism, weight gain, fatigue, and hair loss.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health professional before use.

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

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

1 drop under tongue or as directed by a health practitioner. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 20% Ethanol, Glycerin, Kelp (Whole Plant) (Laminaria spp.) Extract, Potassium Iodide USP, Sodium Iodide USP.

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.

INDICATIONS:

INDICATIONS & USAGE SECTION

Formulated for symptoms such as sluggish metabolism, weight gain, fatigue, and hair loss.

QUESTIONS:

OTC - QUESTIONS SECTION

Proprietary Blend for Institute for Wholistic Rejuvenation.

Dist. by: Institute for Wholistic

Rejuvenation, Sandpoint, ID 83864

www.gloriagilbere.com

(888) 352.8175

PACKAGE DISPLAY LABEL:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WHOLISTIC

THYROID

BALANCE

HOMEOPATHIC

INSTITUTE FOR

WHOLISTIC

REJUVENATION

1 fl. oz. (30 ml)

WHOLISTIC THYROID BALANCEWHOLISTIC THYROID BALANCE

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130640522597802GTIN-13: 0640522597802
EAN-13: 0640522597802
GTIN-12: 640522597802
UPC-A: 640522597802
GTIN storage (14 digits): 00640522597802		ENRGGLGL0237 Wholistic Thyroid Balance 1-3-23.jpg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
FUCUS VESICULOSUSACTIVE INGREDIENT535G2ABX9M2
SPONGIA OFFICINALIS SKELETON, ROASTEDACTIVE INGREDIENT1PIP394IID2
SUS SCROFA THYROIDACTIVE INGREDIENT6RV024OAUQ2
FUCUS VESICULOSUSACTIVE MOIETY535G2ABX9M2
SPONGIA OFFICINALIS SKELETON, ROASTEDACTIVE MOIETY1PIP394IID2
SUS SCROFA THYROIDACTIVE MOIETY6RV024OAUQ2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
LAMINARIA DIGITATAINACTIVE INGREDIENT15E7C67EE82
POTASSIUM IODIDEINACTIVE INGREDIENT1C4QK22F9J2
SODIUM IODIDEINACTIVE INGREDIENTF5WR8N145C2
WATERINACTIVE INGREDIENT059QF0KO0R2

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
55330-000155330-0001-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
FUCUS VESICULOSUS535G2ABX9MACTIB
SUS SCROFA THYROID6RV024OAUQACTIB
SPONGIA OFFICINALIS SKELETON, ROASTED1PIP394IIDACTIB
SODIUM IODIDEF5WR8N145CIACT
POTASSIUM IODIDE1C4QK22F9JIACT
LAMINARIA DIGITATA15E7C67EE8IACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62023-04-03full-release2026-06-01 02:20:44

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 1 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM IODIDESODIUM IODIDEF5WR8N145CDOUCHE / VAGINAL0.75 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM IODIDESODIUM IODIDEF5WR8N145CSPONGE / TOPICAL0.74 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM IODIDESODIUM IODIDEF5WR8N145CINJECTION / INTRAVENOUS10 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM IODIDESODIUM IODIDEF5WR8N145CINJECTION / INTRAVENOUS10 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM IODIDESODIUM IODIDEF5WR8N145CSPONGE / TOPICAL0.74 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM IODIDESODIUM IODIDEF5WR8N145CDOUCHE / VAGINAL0.75 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
4c37603e-04de-4269-b6d6-d53234b5c89cb45aa21e-1a4b-4589-8687-e41a52f527dc2023-04-03WarningsExact identifier
spl set id: b45aa21e-1a4b-4589-8687-e41a52f527dc

Reported adverse events (FAERS/openFDA)#

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