FDA.reportPublic FDA data

THYRO TONIC

Product NDC
43857-0549
11-digit product format
438570549
Labeler code
43857
Product ID
43857-0549_c94d93e8-2002-4de4-adc1-a4879d7bafbf
Type
HUMAN OTC DRUG
Nonproprietary name
Chelidonium Majus, Spongia Tosta, Lac Defloratum, Fucus Vesiculosus, Hepar Suis, Hypophysis Suis, Thyroidinum (Suis), Calcarea Carbonica, Ferrum Iodatum, Iodium, Kali Iodatum, Molybdenum, Pulsatilla (Pratensis)
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-02-26
Substance
CHELIDONIUM MAJUS WHOLE; FERROUS IODIDE; FUCUS VESICULOSUS; IODINE; MOLYBDENUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PORK LIVER; POTASSIUM IODIDE; PULSATILLA PRATENSIS WHOLE; SKIM MILK; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA PITUITARY GLAND; THYROID
Active strength
3; 12; 6; 12; 12; 12; 8; 12; 12; 4; 3; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHELIDONIUM MAJUS WHOLE3 [hp_X]/mL
FERROUS IODIDE12 [hp_X]/mL
FUCUS VESICULOSUS6 [hp_X]/mL
IODINE12 [hp_X]/mL
MOLYBDENUM12 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]/mL
PORK LIVER8 [hp_X]/mL
POTASSIUM IODIDE12 [hp_X]/mL
PULSATILLA PRATENSIS WHOLE12 [hp_X]/mL
SKIM MILK4 [hp_X]/mL
SPONGIA OFFICINALIS SKELETON, ROASTED3 [hp_X]/mL
SUS SCROFA PITUITARY GLAND8 [hp_X]/mL
THYROID8 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7E889U5RNN, F5452U54PN, 535G2ABX9M, 9679TC07X4, 81AH48963U, 2E32821G6I, 6EC706HI7F, 1C4QK22F9J, 8E272251DI, 6A001Y4M5A, 1PIP394IID, L0PFEMQ1DT, 6RV024OAUQ

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0549-12024-09-12C16284748780-1d6a99b39-ee7b-a426-e053-dadaa90af4c2DRUG FACTS:
43857-0549-12022-01-28C16284748780-1d6a99b39-ee7b-a426-e053-dadaa90af4c2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0549-1THYRO TONIC30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0549THYRO TONIC (CHELIDONIUM MAJUS, SPONGIA TOSTA, LAC DEFLORATUM, FUCUS VESICULOSUS, HEPAR SUIS, HYPOPHYSIS SUIS, THYROIDINUM (SUIS), CALCAREA CARBONICA, FERRUM IODATUM, IODIUM, KALI IODATUM, MOLYBDENUM, PULSATILLA (PRATENSIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20240913_d4639170-d788-4644-97ad-ad518dca4552.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0549-14385705490130 mL in 1 BOTTLE, DROPPER (43857-0549-1) 30 ml2020-02-260000-00-00NoNoCurrent