gds-calm

Generic: digestive balance

Labeler: vitality works, inc.
NDC Directory HUMAN OTC DRUG UNAPPROVED HOMEOPATHIC Inactive Finished

Drug Facts

Product Profile

Brand Name gds-calm
Generic Name digestive balance
Labeler vitality works, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

aspidosperma quebracho-blanco bark 6 [hp_X]/mL, candida albicans 14 [hp_X]/mL, chamaemelum nobile 14 [hp_X]/mL, chrysopogon zizanioides root 7 [hp_X]/mL, helianthemum canadense 8 [hp_X]/mL, horse chestnut 7 [hp_X]/mL, lilium lancifolium whole flowering 15 [hp_X]/mL, robinia pseudoacacia bark 7 [hp_X]/mL, syzygium jambos seed 7 [hp_X]/mL, virola sebifera resin 7 [hp_X]/mL

Manufacturer
Vitality Works, Inc.

Identifiers & Regulatory

Product NDC 64616-092
Product ID 64616-092_462f5aa4-db6b-26dd-e063-6294a90a4030
Product Type HUMAN OTC DRUG
Marketing Category UNAPPROVED HOMEOPATHIC
Listing Expiration 2026-12-31
Marketing Start 2013-04-17

Pharmacologic Class

Established (EPC)
non-standardized fungal allergenic extract [epc]
Chemical Structure
fungal proteins [cs] allergens [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 64616092
Hyphenated Format 64616-092

Supplemental Identifiers

UNII
52B1340190 4D7G21HDBC 7NF3GE7IWR 37TB8LUP9Z 46G3W789Q3 3C18L6RJAZ X67Z2963PI 7TPC058OWY 97P0H45869 GHJ5XX5SGS
NUI
N0000185372 N0000175629 N0000184306 N0000185001 M0008890 M0000728

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 gds-calm (source: ndc)
Generic Name digestive balance (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6 [hp_X]/mL
  • 14 [hp_X]/mL
  • 7 [hp_X]/mL
  • 8 [hp_X]/mL
  • 15 [hp_X]/mL
source: ndc
Packaging
  • 59 mL in 1 BOTTLE, DROPPER (64616-092-02)
source: ndc

Packages (1)

Ingredients (10)

aspidosperma quebracho-blanco bark (6 [hp_X]/mL) candida albicans (14 [hp_X]/mL) chamaemelum nobile (14 [hp_X]/mL) chrysopogon zizanioides root (7 [hp_X]/mL) helianthemum canadense (8 [hp_X]/mL) horse chestnut (7 [hp_X]/mL) lilium lancifolium whole flowering (15 [hp_X]/mL) robinia pseudoacacia bark (7 [hp_X]/mL) syzygium jambos seed (7 [hp_X]/mL) virola sebifera resin (7 [hp_X]/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "462f5aa4-db6b-26dd-e063-6294a90a4030", "openfda": {"nui": ["N0000185372", "N0000175629", "N0000184306", "N0000185001", "M0008890", "M0000728"], "unii": ["52B1340190", "4D7G21HDBC", "7NF3GE7IWR", "37TB8LUP9Z", "46G3W789Q3", "3C18L6RJAZ", "X67Z2963PI", "7TPC058OWY", "97P0H45869", "GHJ5XX5SGS"], "spl_set_id": ["138bfd5e-6586-4fec-bd77-469bad10d1da"], "pharm_class_cs": ["Fungal Proteins [CS]", "Allergens [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]"], "pharm_class_epc": ["Non-Standardized Fungal Allergenic Extract [EPC]"], "manufacturer_name": ["Vitality Works, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "59 mL in 1 BOTTLE, DROPPER (64616-092-02)", "package_ndc": "64616-092-02", "marketing_start_date": "20130417"}], "brand_name": "GDS-Calm", "product_id": "64616-092_462f5aa4-db6b-26dd-e063-6294a90a4030", "dosage_form": "LIQUID", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Fungal Proteins [CS]", "Increased Histamine Release [PE]", "Increased IgG Production [PE]", "Non-Standardized Fungal Allergenic Extract [EPC]"], "product_ndc": "64616-092", "generic_name": "Digestive Balance", "labeler_name": "Vitality Works, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "GDS-Calm", "active_ingredients": [{"name": "ASPIDOSPERMA QUEBRACHO-BLANCO BARK", "strength": "6 [hp_X]/mL"}, {"name": "CANDIDA ALBICANS", "strength": "14 [hp_X]/mL"}, {"name": "CHAMAEMELUM NOBILE", "strength": "14 [hp_X]/mL"}, {"name": "CHRYSOPOGON ZIZANIOIDES ROOT", "strength": "7 [hp_X]/mL"}, {"name": "HELIANTHEMUM CANADENSE", "strength": "8 [hp_X]/mL"}, {"name": "HORSE CHESTNUT", "strength": "7 [hp_X]/mL"}, {"name": "LILIUM LANCIFOLIUM WHOLE FLOWERING", "strength": "15 [hp_X]/mL"}, {"name": "ROBINIA PSEUDOACACIA BARK", "strength": "7 [hp_X]/mL"}, {"name": "SYZYGIUM JAMBOS SEED", "strength": "7 [hp_X]/mL"}, {"name": "VIROLA SEBIFERA RESIN", "strength": "7 [hp_X]/mL"}], "marketing_category": "UNAPPROVED HOMEOPATHIC", "marketing_start_date": "20130417", "listing_expiration_date": "20261231"}