am-5

Generic: helleborus niger whole, magnesium phosphate, dibasic trihydrate, and bos taurus bile

Labeler: dna labs, inc.
NDC Directory HUMAN OTC DRUG UNAPPROVED HOMEOPATHIC Inactive Finished

Drug Facts

Product Profile

Brand Name am-5
Generic Name helleborus niger whole, magnesium phosphate, dibasic trihydrate, and bos taurus bile
Labeler dna labs, inc.
Dosage Form SOLUTION
Routes
SUBLINGUAL
Active Ingredients

bos taurus bile 12 [hp_X]/mL, helleborus niger whole 8 [hp_X]/mL, magnesium phosphate, dibasic trihydrate 8 [hp_X]/mL

Manufacturer
DNA Labs, Inc.

Identifiers & Regulatory

Product NDC 58264-0344
Product ID 58264-0344_2b52dd9d-5dee-a801-e063-6294a90aeffa
Product Type HUMAN OTC DRUG
Marketing Category UNAPPROVED HOMEOPATHIC
Listing Expiration 2026-12-31
Marketing Start 1990-01-01

Pharmacologic Class

Classes
calculi dissolution agent [epc] increased large intestinal motility [pe] inhibition large intestine fluid/electrolyte absorption [pe] inhibition small intestine fluid/electrolyte absorption [pe] magnesium ion exchange activity [moa] osmotic activity [moa] osmotic laxative [epc] stimulation large intestine fluid/electrolyte secretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 582640344
Hyphenated Format 58264-0344

Supplemental Identifiers

UNII
ET3651ZLOU H0NO2VNJ61 HF539G9L3Q

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name am-5 (source: ndc)
Generic Name helleborus niger whole, magnesium phosphate, dibasic trihydrate, and bos taurus bile (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 12 [hp_X]/mL
  • 8 [hp_X]/mL
source: ndc
Packaging
  • 29.57 mL in 1 BOTTLE, GLASS (58264-0344-1)
source: ndc

Packages (1)

58264-0344-1 29.57 mL in 1 BOTTLE, GLASS (58264-0344-1)

Ingredients (3)

bos taurus bile (12 [hp_X]/mL) helleborus niger whole (8 [hp_X]/mL) magnesium phosphate, dibasic trihydrate (8 [hp_X]/mL)

Linked Drug Pages (1)

AM-5 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "2b52dd9d-5dee-a801-e063-6294a90aeffa", "openfda": {"unii": ["ET3651ZLOU", "H0NO2VNJ61", "HF539G9L3Q"], "spl_set_id": ["0d4b5527-cc14-4dd0-84d9-b403e281f1fe"], "manufacturer_name": ["DNA Labs, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "29.57 mL in 1 BOTTLE, GLASS (58264-0344-1)", "package_ndc": "58264-0344-1", "marketing_start_date": "19900101"}], "brand_name": "AM-5", "product_id": "58264-0344_2b52dd9d-5dee-a801-e063-6294a90aeffa", "dosage_form": "SOLUTION", "pharm_class": ["Calculi Dissolution Agent [EPC]", "Increased Large Intestinal Motility [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]", "Magnesium Ion Exchange Activity [MoA]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "58264-0344", "generic_name": "HELLEBORUS NIGER WHOLE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, and BOS TAURUS BILE", "labeler_name": "DNA Labs, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "AM-5", "active_ingredients": [{"name": "BOS TAURUS BILE", "strength": "12 [hp_X]/mL"}, {"name": "HELLEBORUS NIGER WHOLE", "strength": "8 [hp_X]/mL"}, {"name": "MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE", "strength": "8 [hp_X]/mL"}], "marketing_category": "UNAPPROVED HOMEOPATHIC", "marketing_start_date": "19900101", "listing_expiration_date": "20261231"}