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 |
|---|
| 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 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 52B1340190, 4D7G21HDBC, 7NF3GE7IWR, 37TB8LUP9Z, 46G3W789Q3, 3C18L6RJAZ, X67Z2963PI, 7TPC058OWY, 97P0H45869, GHJ5XX5SGS |
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 |
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 |