Over-the-counter drug · UNAPPROVED HOMEOPATHIC
Comfort for Teething NDC 64616-115
Magnesium phosphate, Monobasic, Unspecified 6 [hp_X]/.05mL + 5 more ingredients · Liquid · Oral · Vitality Works, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64616-115-01 | 6461601150164616011501 | 30 mL in 1 BOTTLE, DROPPER (64616-115-01)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 Teething
- Generic name (nonproprietary)
- comfort for teething
- Active ingredients
- Magnesium phosphate, Monobasic, Unspecified — 6 [hp_X]/.05mLChamomile — 3 [hp_X]/.05mLArnica montana — 6 [hp_X]/.05mLTribasic calcium phosphate — 6 [hp_X]/.05mLWood creosote — 6 [hp_X]/.05mLRheum officinale root — 6 [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
- Other FDA classes
- Calcium (Chemical structure)Divalent (Chemical structure)Increased Coagulation Factor Activity (Physiologic effect)Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 64616-115_462f6324-888c-e31c-e063-6394a90ad915SPL ID 462f6324-888c-e31c-e063-6394a90ad915SPL set ID 21b44c37-4fc8-14b4-e054-00144ff8d46cUNII W30T5D628Q, FGL3685T2X, O80TY208ZW, 91D9GV0Z28, 3JYG22FD73, A47JP5ZG9M
- Pharmacologic class
- Blood Coagulation Factor; Phosphate Binder
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
N464616011501followed by a unit qualifier and the quantityPackage 64616-0115-01. 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)
For the temporary relief of teething pain, soreness and inflammation of gums, restlessness and irritability related to teething
Excerpt only. Read the full label for complete information.
About NDC 64616-115
- What is NDC 64616-115?
- 64616-115 is the product NDC for Comfort for Teething, Magnesium phosphate, Monobasic, Unspecified 6 [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 Teething.
- What is the active ingredient?
- Magnesium phosphate, Monobasic, Unspecified, Chamomile, Arnica montana, Tribasic calcium phosphate, Wood creosote, Rheum officinale root.
- 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 Teething?
- 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.