FDA.reportPublic FDA data

THYROPRO

Product NDC
43853-0040
11-digit product format
438530040
Labeler code
43853
Product ID
43853-0040_eeb3d0e2-fd99-3ad5-e053-2a95a90a3231
Type
HUMAN OTC DRUG
Nonproprietary name
Calcarea iodata, Ferrum iodatum, Kali iodatum, Spongia tosta, Fucus vesiculosus, Thyroidinum, Glandula suprarenalis, Hypophysis, Lapis albus, Hydrofluoricum acidum
Dosage form
LIQUID
Route
ORAL
Labeler
ProBlen
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-12-10
Substance
CALCIUM HEXAFLUOROSILICATE; CALCIUM IODIDE; FERROUS IODIDE; FUCUS VESICULOSUS; HYDROFLUORIC ACID; POTASSIUM IODIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED
Active strength
30; 12; 12; 3; 12; 6; 6; 6; 6; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
THYROPRO
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUS SCROFA PITUITARY GLAND30 [hp_X]/30mL
CALCIUM HEXAFLUOROSILICATE12 [hp_X]/30mL
HYDROFLUORIC ACID12 [hp_X]/30mL
CALCIUM IODIDE3 [hp_X]/30mL
FERROUS IODIDE12 [hp_C]/30mL
POTASSIUM IODIDE6 [hp_X]/30mL
SPONGIA OFFICINALIS SKELETON, ROASTED6 [hp_X]/30mL
FUCUS VESICULOSUS6 [hp_X]/30mL
THYROID, UNSPECIFIED6 [hp_X]/30mL
SUS SCROFA ADRENAL GLAND6 [hp_X]/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L0PFEMQ1DTInternal UNII lookup
2NVP93XVQ3Internal UNII lookup
RGL5YE86CZInternal UNII lookup
8EKI9QEE2HInternal UNII lookup
F5452U54PNInternal UNII lookup
1C4QK22F9JInternal UNII lookup
1PIP394IIDInternal UNII lookup
535G2ABX9MInternal UNII lookup
0B4FDL9I6PInternal UNII lookup
398IYQ16YVInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e69b797a-678f-4173-9c6c-97b7ba436fbeAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43853-0040-1THYROPRO30 mL in 1 BOTTLELIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43853-0040THYROPRO (CALCAREA IODATA, FERRUM IODATUM, KALI IODATUM, SPONGIA TOSTA, FUCUS VESICULOSUS, THYROIDINUM, GLANDULA SUPRARENALIS, HYPOPHYSIS, LAPIS ALBUS, HYDROFLUORICUM ACIDUM) LIQUID [PROBLEN]2Current NDC, Legacy NDC, 1 package rows20221201_e69b797a-678f-4173-9c6c-97b7ba436fbe.zip

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
THYROPROCALCAREA IODATA, FERRUM IODATUM, KALI IODATUM, SPONGIA TOSTA, FUCUS VESICULOSUS, THYROIDINUM, GLANDULA SUPRARENALIS, HYPOPHYSIS, LAPIS ALBUS, HYDROFLUORICUM ACIDUMProBlene69b797a-678f-4173-9c6c-97b7ba436fbe2022-11-30WarningsExact identifier
ndc (product): 43853-0040

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43853-0040-14385300400130 mL in 1 BOTTLE (43853-0040-1) 30 ml2021-12-100000-00-00NoNoCurrent