Home NDC 64616-092 GDS-Calm
Product NDC 64616-092
11-digit product format 646160092
Labeler code 64616
Product ID 64616-092_462f5aa4-db6b-26dd-e063-6294a90a4030
Type HUMAN OTC DRUG
Nonproprietary name Digestive Balance
Dosage form LIQUID
Route ORAL
Labeler Vitality Works, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2013-04-17
Substance ASPIDOSPERMA QUEBRACHO-BLANCO BARK; CANDIDA ALBICANS; CHAMAEMELUM NOBILE; CHRYSOPOGON ZIZANIOIDES ROOT; HELIANTHEMUM CANADENSE; HORSE CHESTNUT; LILIUM LANCIFOLIUM WHOLE FLOWERING; ROBINIA PSEUDOACACIA BARK; SYZYGIUM JAMBOS SEED; VIROLA SEBIFERA RESIN
Active strength 6; 14; 14; 7; 8; 7; 15; 7; 7; 7 [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 Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base GDS-Calm
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HORSE CHESTNUT 6 [hp_X]/mL CHRYSOPOGON ZIZANIOIDES ROOT 14 [hp_X]/mL CHAMAEMELUM NOBILE 14 [hp_X]/mL CANDIDA ALBICANS 7 [hp_X]/mL HELIANTHEMUM CANADENSE 8 [hp_X]/mL SYZYGIUM JAMBOS SEED 7 [hp_X]/mL LILIUM LANCIFOLIUM WHOLE FLOWERING 15 [hp_X]/mL VIROLA SEBIFERA RESIN 7 [hp_X]/mL ASPIDOSPERMA QUEBRACHO-BLANCO BARK 7 [hp_X]/mL ROBINIA PSEUDOACACIA BARK 7 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 10 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64616-092-02 GDS-Calm 59 mL in 1 BOTTLE, DROPPER LIQUID 59 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ASPIDOSPERMA QUEBRACHO-BLANCO BARK ACTIVE INGREDIENT 52B1340190 GDS-CALM (DIGESTIVE BALANCE) LIQUID [VITALITY WORKS, INC.] 1 CANDIDA ALBICANS ACTIVE INGREDIENT 4D7G21HDBC GDS-CALM (DIGESTIVE BALANCE) LIQUID [VITALITY WORKS, INC.] 1 CHAMAEMELUM NOBILE ACTIVE INGREDIENT 7NF3GE7IWR GDS-CALM (DIGESTIVE BALANCE) LIQUID [VITALITY WORKS, INC.] 1 CHRYSOPOGON ZIZANIOIDES ROOT ACTIVE INGREDIENT 37TB8LUP9Z GDS-CALM (DIGESTIVE BALANCE) LIQUID [VITALITY WORKS, INC.] 1 HELIANTHEMUM CANADENSE ACTIVE INGREDIENT 46G3W789Q3 GDS-CALM (DIGESTIVE BALANCE) LIQUID [VITALITY WORKS, INC.] 1 HORSE CHESTNUT ACTIVE INGREDIENT 3C18L6RJAZ GDS-CALM (DIGESTIVE BALANCE) LIQUID [VITALITY WORKS, INC.] 1 LILIUM LANCIFOLIUM WHOLE FLOWERING ACTIVE INGREDIENT X67Z2963PI GDS-CALM (DIGESTIVE BALANCE) LIQUID [VITALITY WORKS, INC.] 1 ROBINIA PSEUDOACACIA BARK ACTIVE INGREDIENT 7TPC058OWY GDS-CALM (DIGESTIVE BALANCE) LIQUID [VITALITY WORKS, INC.] 1 SYZYGIUM JAMBOS SEED ACTIVE INGREDIENT 97P0H45869 GDS-CALM (DIGESTIVE BALANCE) LIQUID [VITALITY WORKS, INC.] 1 VIROLA SEBIFERA RESIN ACTIVE INGREDIENT GHJ5XX5SGS GDS-CALM (DIGESTIVE BALANCE) LIQUID [VITALITY WORKS, INC.] 1 ASPIDOSPERMA QUEBRACHO-BLANCO BARK ACTIVE MOIETY 52B1340190 GDS-CALM (DIGESTIVE BALANCE) LIQUID [VITALITY WORKS, INC.] 1 CANDIDA ALBICANS ACTIVE MOIETY 4D7G21HDBC GDS-CALM (DIGESTIVE BALANCE) LIQUID [VITALITY WORKS, INC.] 1 CHAMAEMELUM NOBILE ACTIVE MOIETY 7NF3GE7IWR GDS-CALM (DIGESTIVE BALANCE) LIQUID [VITALITY WORKS, INC.] 1 CHRYSOPOGON ZIZANIOIDES ROOT ACTIVE MOIETY 37TB8LUP9Z GDS-CALM (DIGESTIVE BALANCE) LIQUID [VITALITY WORKS, INC.] 1 HELIANTHEMUM CANADENSE ACTIVE MOIETY 46G3W789Q3 GDS-CALM (DIGESTIVE BALANCE) LIQUID [VITALITY WORKS, INC.] 1 HORSE CHESTNUT ACTIVE MOIETY 3C18L6RJAZ GDS-CALM (DIGESTIVE BALANCE) LIQUID [VITALITY WORKS, INC.] 1 LILIUM LANCIFOLIUM WHOLE FLOWERING ACTIVE MOIETY X67Z2963PI GDS-CALM (DIGESTIVE BALANCE) LIQUID [VITALITY WORKS, INC.] 1 ROBINIA PSEUDOACACIA BARK ACTIVE MOIETY 7TPC058OWY GDS-CALM (DIGESTIVE BALANCE) LIQUID [VITALITY WORKS, INC.] 1 SYZYGIUM JAMBOS SEED ACTIVE MOIETY 97P0H45869 GDS-CALM (DIGESTIVE BALANCE) LIQUID [VITALITY WORKS, INC.] 1 VIROLA SEBIFERA RESIN ACTIVE MOIETY GHJ5XX5SGS GDS-CALM (DIGESTIVE BALANCE) LIQUID [VITALITY WORKS, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M GDS-CALM (DIGESTIVE BALANCE) LIQUID [VITALITY WORKS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R GDS-CALM (DIGESTIVE BALANCE) LIQUID [VITALITY WORKS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64616-092 GDS-CALM (DIGESTIVE BALANCE) LIQUID [VITALITY WORKS, INC.] 7 Current NDC, Legacy NDC, 1 package rows 20241212_138bfd5e-6586-4fec-bd77-469bad10d1da.zip
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64616-092-02 64616009202 59 mL in 1 BOTTLE, DROPPER (64616-092-02) 59 ml 2013-04-17 0000-00-00 No No Current