Kidney Tonic

Product NDC
43857-0579
11-digit product format
438570579
Labeler code
43857
Product ID
43857-0579_d982cfaf-a3a2-40a7-a495-5e5abc27ba6b
Type
HUMAN OTC DRUG
Nonproprietary name
Glutathione, Kidney (Suis), Urinary Bladder (Suis), Agrimonia Eupatoria Flos, Apis Mellifica, Berberis Vulgaris, Bryonia (Alba), Calcarea Carbonica, Galium Aparine, Rubia Tinctorum
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-02-18
Substance
AGRIMONIA EUPATORIA FLOWER; APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA WHOLE; GALIUM APARINE WHOLE; GLUTATHIONE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PORK KIDNEY; RUBIA TINCTORUM ROOT; SUS SCROFA URINARY BLADDER
Active strength
8; 12; 12; 12; 12; 6; 12; 6; 12; 6 [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
Pharmacologic classes
Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Kidney Tonic
Brand name suffix
II
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AGRIMONIA EUPATORIA FLOWER8 [hp_X]/mL
APIS MELLIFERA12 [hp_X]/mL
BERBERIS VULGARIS ROOT BARK12 [hp_X]/mL
BRYONIA ALBA WHOLE12 [hp_X]/mL
GALIUM APARINE WHOLE12 [hp_X]/mL
GLUTATHIONE6 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]/mL
PORK KIDNEY6 [hp_X]/mL
RUBIA TINCTORUM ROOT12 [hp_X]/mL
SUS SCROFA URINARY BLADDER6 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5811MI029U, 7S82P3R43Z, 1TH8Q20J0U, 56K0VVT47P, Z4B6561488, GAN16C9B8O, 2E32821G6I, X7BCI5P86H, 0SVP95L23G, 3G7U72W8DA

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0579-12024-08-29C16284748780-1f386c649-ec6b-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0579-12023-01-30C16284748780-1f386c649-ec6b-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0579-1Kidney TonicII60 mL in 1 BOTTLE, DROPPERLIQUID603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0579KIDNEY TONIC II (GLUTATHIONE, KIDNEY (SUIS), URINARY BLADDER (SUIS), AGRIMONIA EUPATORIA FLOS, APIS MELLIFICA, BERBERIS VULGARIS, BRYONIA (ALBA), CALCAREA CARBONICA, GALIUM APARINE, RUBIA TINCTORUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20240830_8fbc8293-2bf3-4c8e-9cc6-4b0301ec077d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0579-14385705790160 mL in 1 BOTTLE, DROPPER (43857-0579-1) 60 ml2021-02-180000-00-00NoNoCurrent