What is NDC 64616-050?

64616-050 is the product NDC for Pediatric Earache Remedy (ear drops), Aconitum napellus 6 [hp_X]/mL + 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?

Pediatric Earache Remedy (Ear Drops).

What is the active ingredient?

Aconitum napellus, Atropa belladonna, Potassium chloride, Plantago major, Matricaria recutita, Verbascum thapsus.

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 Pediatric Earache Remedy?

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.

Pediatric Earache Remedy NDC 64616-050

NDC codes

FDA NDC Directory

Product NDC (as listed)64616-050Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64616-0050Add 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
64616-050-02	6461600500264616005002	1 BOTTLE, DROPPER in 1 CARTON (64616-050-02) / 15 mL in 1 BOTTLE, DROPPER (64616-050-01)Marketed from Jul 30, 2007

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): Pediatric Earache Remedy
Generic name (nonproprietary): ear drops
Active ingredients: Aconitum napellus — 6 [hp_X]/mLAtropa belladonna — 3 [hp_X]/mLPotassium chloride — 3 [hp_X]/mLPlantago major — 3 [hp_X]/mLMatricaria recutita — 6 [hp_X]/mLVerbascum thapsus — 6 [hp_X]/mL
Dosage form: Liquid
Route: Auricular (Otic)
Labeler: Vitality Works, IncNDC labeler code 64616
Product type: Over-the-counter drug
Marketing category: Unapproved homeopathic
Marketing start: Oct 23, 2006
Listing expires: Dec 31, 2026
Other FDA classes: Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Osmotic Activity (Mechanism)Potassium Compounds (Chemical structure)
Identifiers: Product ID 64616-050_462ed52e-9da2-6cc3-e063-6294a90ad318SPL ID 462ed52e-9da2-6cc3-e063-6294a90ad318SPL set ID 5769ce2c-d2e1-4069-92cc-e38bee668dafUNII U0NQ8555JD, WQZ3G9PF0H, 660YQ98I10, W2469WNO6U, G0R4UBI2ZZ, C9TD27U172UPC 0019277000569
Pharmacologic class: Osmotic Laxative; Potassium Salt

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N464616005002 followed by a unit qualifier and the quantity

Package 64616-0050-02. 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)

Pediatric Earache Remedy A homeopathic combination for the temporary relief of earaches, inflammation of external and internal ear. For the temporary relief of earaches from congestion or swelling of middle ear or eustacian tubes.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64616-050

What is NDC 64616-050?: 64616-050 is the product NDC for Pediatric Earache Remedy (ear drops), Aconitum napellus 6 [hp_X]/mL + 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?: Pediatric Earache Remedy (Ear Drops).
What is the active ingredient?: Aconitum napellus, Atropa belladonna, Potassium chloride, Plantago major, Matricaria recutita, Verbascum thapsus.
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 Pediatric Earache Remedy?: 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.

Pediatric Earache Remedy (Ear drops) NDC 64616-050