NDC codes

FDA NDC Directory
Product NDC (as listed)64616-116Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64616-0116Add 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 NDC11-digit (billing)PackageCopy
64616-116-01646160116016461601160130 mL in 1 BOTTLE, DROPPER (64616-116-01)Marketed from Jan 14, 2016

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)
Comfort for Colic
Generic name (nonproprietary)
comfort for kids
Active ingredients
Pulsatilla pratensis — 4 [hp_X]/.05mLAethusa cynapium — 4 [hp_X]/.05mLDioscorea villosa tuber — 6 [hp_X]/.05mLMagnesium phosphate, Dibasic — 6 [hp_X]/.05mLChamomile — 4 [hp_X]/.05mLCitrullus colocynthis fruit — 4 [hp_X]/.05mL
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
Listing expires
Identifiers
Product ID 64616-116_462f5bc0-eea3-2be8-e063-6294a90a958dSPL ID 462f5bc0-eea3-2be8-e063-6294a90a958dSPL set ID 220209c1-18ab-1b78-e054-00144ff8d46cUNII 8E272251DI, M6936L953C, IWY3IWX2G8, A1Y870209Z, FGL3685T2X, 0E49E3V9U6

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

N464616011601 followed by a unit qualifier and the quantity

Package 64616-0116-01. 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 .

Indications (excerpt from the label)

Indications For the temporary relief of colic symptoms, including stomach pain, vomiting, gas, cramping and irritability. For the temporary relief of colic symptoms, including stomach pain, vomiting, gas, cramping and irritability

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64616-116

What is NDC 64616-116?
64616-116 is the product NDC for Comfort for Colic (comfort for kids), Pulsatilla pratensis 4 [hp_X]/.05mL + 5 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?
Comfort for Colic (Comfort for Kids).
What is the active ingredient?
Pulsatilla pratensis, Aethusa cynapium, Dioscorea villosa tuber, Magnesium phosphate, Dibasic, Chamomile, Citrullus colocynthis fruit.
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 Comfort for Colic?
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.

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