What is NDC 64616-092?

64616-092 is the product NDC for GDS-Calm (digestive balance), Horse chestnut 7 [hp_X]/mL + 9 more ingredients liquid, listed with the FDA by Vitality Works, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Horse 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.

Vitality Works, Inc., NDC labeler code 64616. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for GDS-Calm?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

GDS-Calm NDC 64616-092 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)64616-092Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64616-0092Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
64616-092-02	6461600920264616009202	59 mL in 1 BOTTLE, DROPPER (64616-092-02)Marketed from Apr 17, 2013

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): GDS-Calm
Generic name (nonproprietary): digestive balance
Active ingredients: Horse chestnut — 7 [hp_X]/mLChrysopogon zizanioides root — 7 [hp_X]/mLChamaemelum nobile — 14 [hp_X]/mLCandida albicans — 14 [hp_X]/mLHelianthemum canadense — 8 [hp_X]/mLSyzygium jambos seed — 7 [hp_X]/mLLilium lancifolium whole flowering — 15 [hp_X]/mLVirola sebifera resin — 7 [hp_X]/mLAspidosperma quebracho-blanco bark — 6 [hp_X]/mLRobinia pseudoacacia bark — 7 [hp_X]/mL
Dosage form: Liquid
Route: Oral
Labeler: Vitality Works, Inc.NDC labeler code 64616
Product type: Over-the-counter drug
Marketing category: Unapproved homeopathic
Marketing start: Apr 17, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Fungal Proteins (Chemical structure)Increased Histamine Release (Physiologic effect)Increased IgG Production (Physiologic effect)
Identifiers: Product ID 64616-092_462f5aa4-db6b-26dd-e063-6294a90a4030SPL ID 462f5aa4-db6b-26dd-e063-6294a90a4030SPL set ID 138bfd5e-6586-4fec-bd77-469bad10d1daUNII 3C18L6RJAZ, 37TB8LUP9Z, 7NF3GE7IWR, 4D7G21HDBC, 46G3W789Q3, 97P0H45869, X67Z2963PI, GHJ5XX5SGS, 52B1340190, 7TPC058OWY
Pharmacologic class: Non-Standardized Fungal Allergenic Extract

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N464616009202 followed by a unit qualifier and the quantity

Package 64616-0092-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Dec 17, 2025.

Indications (excerpt from the label)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64616-092

What is NDC 64616-092?: 64616-092 is the product NDC for GDS-Calm (digestive balance), Horse chestnut 7 [hp_X]/mL + 9 more ingredients liquid, listed with the FDA by Vitality Works, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: GDS-Calm (Digestive Balance).
What is the active ingredient?: Horse 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.
Who is the labeler?: Vitality Works, Inc., NDC labeler code 64616. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for GDS-Calm?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

GDS-Calm (Digestive balance) NDC 64616-092