Hepatatox

Product NDC
43857-0543
11-digit product format
438570543
Labeler code
43857
Product ID
43857-0543_7d04c7a1-60d7-41cb-a0b1-dce634a4cae9
Type
HUMAN OTC DRUG
Nonproprietary name
Triticum Aestivum, Chelidonium Majus, Taraxacum Officinale, Glutathione, Hepar Suis, Thyroidinum (Suis), Lycopodium Clavatum, Nux Vomica, Phosphoricum Acidum, Adrenocorticotrophin, Salicylicum Acidum, Cortisone Aceticum, Eugenol, Stearyl Alcohol, Xylitol, Folliculinum, Benzoicum Acidum, Chlorinum Potassium Sorbate, Sorbitol, Resorcinum, Benzyl Alcohol, Lacticum Acidum, Isopropyl Palmitate, Boricum Acidum, Aceticum Acidum, Phenyl Butazone, Petroleum Jelly, Plumbum Metallicum
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-02-20
Substance
ACETIC ACID; BENZOIC ACID; BENZYL ALCOHOL; BORIC ACID; CHELIDONIUM MAJUS WHOLE; CHLORINE; CORTICOTROPIN; CORTISONE ACETATE; ESTRONE; EUGENOL; GLUTATHIONE; ISOPROPYL PALMITATE; LACTIC ACID, DL-; LEAD; LYCOPODIUM CLAVATUM SPORE; PETROLATUM; PHENYLBUTAZONE; PHOSPHORIC ACID; PORK LIVER; POTASSIUM SORBATE; RESORCINOL; SALICYLIC ACID; SORBITOL; STEARYL ALCOHOL; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; THYROID; TRITICUM AESTIVUM WHOLE; XYLITOL
Active strength
30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 6; 30; 30; 30; 12; 30; 30; 12; 8; 30; 30; 30; 30; 30; 12; 3; 8; 1; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/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; [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
Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Ammonium Ion Binding Activity [MoA], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrogen Binding Agent [EPC], Non-Standardized Plant Allergenic Extract [EPC], Pediculicide [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETIC ACID30 [hp_X]/mL
BENZOIC ACID30 [hp_X]/mL
BENZYL ALCOHOL30 [hp_X]/mL
BORIC ACID30 [hp_X]/mL
CHELIDONIUM MAJUS WHOLE3 [hp_X]/mL
CHLORINE30 [hp_X]/mL
CORTICOTROPIN30 [hp_C]/mL
CORTISONE ACETATE30 [hp_X]/mL
ESTRONE30 [hp_X]/mL
EUGENOL30 [hp_X]/mL
GLUTATHIONE6 [hp_X]/mL
ISOPROPYL PALMITATE30 [hp_X]/mL
LACTIC ACID, DL-30 [hp_X]/mL
LEAD30 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
PETROLATUM30 [hp_X]/mL
PHENYLBUTAZONE30 [hp_X]/mL
PHOSPHORIC ACID12 [hp_X]/mL
PORK LIVER8 [hp_X]/mL
POTASSIUM SORBATE30 [hp_X]/mL
RESORCINOL30 [hp_X]/mL
SALICYLIC ACID30 [hp_X]/mL
SORBITOL30 [hp_X]/mL
STEARYL ALCOHOL30 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/mL
TARAXACUM OFFICINALE3 [hp_X]/mL
THYROID8 [hp_X]/mL
TRITICUM AESTIVUM WHOLE1 [hp_X]/mL
XYLITOL30 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ40Q9N063P, 8SKN0B0MIM, LKG8494WBH, R57ZHV85D4, 7E889U5RNN, 4R7X1O2820, K0U68Q2TXA, 883WKN7W8X, 2DI9HA706A, 3T8H1794QW, GAN16C9B8O, 8CRQ2TH63M, 3B8D35Y7S4, 2P299V784P, C88X29Y479, 4T6H12BN9U, GN5P7K3T8S, E4GA8884NN, 6EC706HI7F, 1VPU26JZZ4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7314d8f7-fa99-4dc2-9f68-de2ff142f4b7Product name220250121
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
16fd7d69-0da3-423a-f064-01fb62860837Product name120140508
9bfd9c37-f773-6e9a-5f6b-6f5701d62adcProduct name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0543-12023-11-02C16284748780-1f386c649-f582-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0543-12023-01-30C16284748780-1f386c649-f582-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0543-1Hepatatox30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0543HEPATATOX (TRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC]3Current NDC, Legacy NDC, 1 package rows20231103_a113a9f1-4792-41a5-8d1b-a6756f356e15.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0543-14385705430130 mL in 1 BOTTLE, DROPPER (43857-0543-1) 30 ml2020-02-200000-00-00NoNoCurrent