am-11

Generic: arnica montana, sodium chloride, and apis mellifera

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

Drug Facts

Product Profile

Brand Name am-11
Generic Name arnica montana, sodium chloride, and apis mellifera
Labeler dna labs, inc.
Dosage Form SOLUTION
Routes
SUBLINGUAL
Active Ingredients

apis mellifera 12 [hp_X]/mL, arnica montana 8 [hp_X]/mL, sodium chloride 8 [hp_X]/mL

Manufacturer
DNA Labs, Inc.

Identifiers & Regulatory

Product NDC 58264-0350
Product ID 58264-0350_2b52fd6d-8b0c-27a7-e063-6394a90a6a9e
Product Type HUMAN OTC DRUG
Marketing Category UNAPPROVED HOMEOPATHIC
Listing Expiration 2026-12-31
Marketing Start 1990-01-01

Pharmacologic Class

Established (EPC)
standardized insect venom allergenic extract [epc]
Chemical Structure
allergens [cs] bee venoms [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe] increased igg production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 582640350
Hyphenated Format 58264-0350

Supplemental Identifiers

UNII
7S82P3R43Z O80TY208ZW 451W47IQ8X
NUI
N0000185021 N0000175629 N0000184306 N0000185001 M0000728 M0002274

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-11 (source: ndc)
Generic Name arnica montana, sodium chloride, and apis mellifera (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 (58264-0350-1)
source: ndc

Packages (1)

58264-0350-1 29.57 mL in 1 BOTTLE, GLASS (58264-0350-1)

Ingredients (3)

apis mellifera (12 [hp_X]/mL) arnica montana (8 [hp_X]/mL) sodium chloride (8 [hp_X]/mL)

Linked Drug Pages (1)

AM-11 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "2b52fd6d-8b0c-27a7-e063-6394a90a6a9e", "openfda": {"nui": ["N0000185021", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0002274"], "unii": ["7S82P3R43Z", "O80TY208ZW", "451W47IQ8X"], "spl_set_id": ["c072811b-6259-4b22-b364-50369dc68fb0"], "pharm_class_cs": ["Allergens [CS]", "Bee Venoms [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]"], "pharm_class_epc": ["Standardized Insect Venom Allergenic Extract [EPC]"], "manufacturer_name": ["DNA Labs, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "29.57 mL in 1 BOTTLE, GLASS (58264-0350-1)", "package_ndc": "58264-0350-1", "marketing_start_date": "19900101"}], "brand_name": "AM-11", "product_id": "58264-0350_2b52fd6d-8b0c-27a7-e063-6394a90a6a9e", "dosage_form": "SOLUTION", "pharm_class": ["Allergens [CS]", "Bee Venoms [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Increased IgG Production [PE]", "Standardized Insect Venom Allergenic Extract [EPC]"], "product_ndc": "58264-0350", "generic_name": "Arnica Montana, Sodium Chloride, and APIS MELLIFERA", "labeler_name": "DNA Labs, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "AM-11", "active_ingredients": [{"name": "APIS MELLIFERA", "strength": "12 [hp_X]/mL"}, {"name": "ARNICA MONTANA", "strength": "8 [hp_X]/mL"}, {"name": "SODIUM CHLORIDE", "strength": "8 [hp_X]/mL"}], "marketing_category": "UNAPPROVED HOMEOPATHIC", "marketing_start_date": "19900101", "listing_expiration_date": "20261231"}