FDA.reportPublic FDA data

GDS-Calm

Manufacturer
Vitality Works, Inc.
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 02:36:03

Label at a glance#

ProductGDS-Calm
Active ingredientHORSE CHESTNUT, CHRYSOPOGON ZIZANIOIDES ROOT, CHAMAEMELUM NOBILE, CANDIDA ALBICANS, HELIANTHEMUM CANADENSE, SYZYGIUM JAMBOS SEED, LILIUM LANCIFOLIUM WHOLE FLOWERING, VIROLA SEBIFERA RESIN, ASPIDOSPERMA QUEBRACHO-BLANCO BARK, ROBINIA PSEUDOACACIA BARK
Label structure8 sections

Label contents#

Full prescribing information#

GDS-Calm

OTC - ACTIVE INGREDIENT SECTION

Aesculus Hippocastanum 7X                    Eugenia Jambosa 7X

Anatherum Muricatum 7X                         Lilium Tigrinum 15X

Anthemis Nobilis 14X                               Myristica Sebifera 7X

Candida Albicans 14X                              Quebracho 6X

Cistus Canadensis 8X                              Robinia Pseudoacacia 7X

GDS-Calm

INACTIVE INGREDIENT SECTION

Alcohol, Purified Water

GDS-Calm

WARNINGS SECTION

Use only under the direction of a health care professional. Do not use if tamper evident seal is broken or missingl.

GDS-Calm

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

GDS-Calm

INDICATIONS & USAGE SECTION

For the temporary relief of stomach upset, flatulence and heartburn.

GDS-Calm

DOSAGE & ADMINISTRATION SECTION

Orally 25 drops, 2 times per day or as indicated by a physician. Children 12 and under use one half the adult dosage.

GDS-Calm

OTC - PURPOSE SECTION

Digestive tract calming.

GDS-Calm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-092-02GDS-Calm59 mL in 1 BOTTLE, DROPPERLIQUID598

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASPIDOSPERMA QUEBRACHO-BLANCO BARKACTIVE INGREDIENT52B13401901
CANDIDA ALBICANSACTIVE INGREDIENT4D7G21HDBC1
CHAMAEMELUM NOBILEACTIVE INGREDIENT7NF3GE7IWR1
CHRYSOPOGON ZIZANIOIDES ROOTACTIVE INGREDIENT37TB8LUP9Z1
HELIANTHEMUM CANADENSEACTIVE INGREDIENT46G3W789Q31
HORSE CHESTNUTACTIVE INGREDIENT3C18L6RJAZ1
LILIUM LANCIFOLIUM WHOLE FLOWERINGACTIVE INGREDIENTX67Z2963PI1
ROBINIA PSEUDOACACIA BARKACTIVE INGREDIENT7TPC058OWY1
SYZYGIUM JAMBOS SEEDACTIVE INGREDIENT97P0H458691
VIROLA SEBIFERA RESINACTIVE INGREDIENTGHJ5XX5SGS1
ASPIDOSPERMA QUEBRACHO-BLANCO BARKACTIVE MOIETY52B13401901
CANDIDA ALBICANSACTIVE MOIETY4D7G21HDBC1
CHAMAEMELUM NOBILEACTIVE MOIETY7NF3GE7IWR1
CHRYSOPOGON ZIZANIOIDES ROOTACTIVE MOIETY37TB8LUP9Z1
HELIANTHEMUM CANADENSEACTIVE MOIETY46G3W789Q31
HORSE CHESTNUTACTIVE MOIETY3C18L6RJAZ1
LILIUM LANCIFOLIUM WHOLE FLOWERINGACTIVE MOIETYX67Z2963PI1
ROBINIA PSEUDOACACIA BARKACTIVE MOIETY7TPC058OWY1
SYZYGIUM JAMBOS SEEDACTIVE MOIETY97P0H458691
VIROLA SEBIFERA RESINACTIVE MOIETYGHJ5XX5SGS1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64616-09264616-092-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
HORSE CHESTNUT3C18L6RJAZACTIB
CHRYSOPOGON ZIZANIOIDES ROOT37TB8LUP9ZACTIB
CHAMAEMELUM NOBILE7NF3GE7IWRACTIB
CANDIDA ALBICANS4D7G21HDBCACTIB
HELIANTHEMUM CANADENSE46G3W789Q3ACTIB
SYZYGIUM JAMBOS SEED97P0H45869ACTIB
LILIUM LANCIFOLIUM WHOLE FLOWERINGX67Z2963PIACTIB
VIROLA SEBIFERA RESINGHJ5XX5SGSACTIB
ASPIDOSPERMA QUEBRACHO-BLANCO BARK52B1340190ACTIB
ROBINIA PSEUDOACACIA BARK7TPC058OWYACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GDS-CalmDIGESTIVE BALANCEVitality Works, Inc.138bfd5e-6586-4fec-bd77-469bad10d1da2025-12-17WarningsExact identifier
ndc (package): 64616-092-02
ndc (product): 64616-092
ndc11 (package): 64616009202
spl id: 462f5aa4-db6b-26dd-e063-6294a90a4030
spl set id: 138bfd5e-6586-4fec-bd77-469bad10d1da

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.