Over-the-counter drug · UNAPPROVED HOMEOPATHIC
Ototone NDC 44911-0467
Baptisia tinctoria root 3 [hp_X]/mL + 9 more ingredients · Liquid · Oral · Energique, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 44911-0467-1 | 4491104670144911046701 | 30 mL in 1 BOTTLE, DROPPER (44911-0467-1)Marketed from Aug 21, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Ototone
- Generic name (nonproprietary)
- baptisia tinctoria, echinacea (angustifolia), hydrastis canadensis, phytolacca decandra, belladonna, calcarea carbonica, chamomilla, ferrum phosphoricum, mercurius solubilis, pulsatilla (pratensis)
- Active ingredients
- Baptisia tinctoria root — 3 [hp_X]/mLEchinacea angustifolia whole — 3 [hp_X]/mLGoldenseal — 6 [hp_X]/mLPhytolacca americana root — 6 [hp_X]/mLAtropa belladonna — 12 [hp_X]/mLOyster shell calcium carbonate, Crude — 12 [hp_X]/mLMatricaria chamomilla whole — 12 [hp_X]/mLFerrosoferric phosphate — 12 [hp_X]/mLMercurius solubilis — 12 [hp_X]/mLPulsatilla pratensis whole — 12 [hp_X]/mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- Energique, Inc.NDC labeler code 44911
- Product type
- Over-the-counter drug
- Marketing category
- Unapproved homeopathic
- Marketing start
- Listing expires
- Identifiers
- Product ID 44911-0467_16dcd12c-ba0d-4cb5-afec-6de76a1bbfaeSPL ID 16dcd12c-ba0d-4cb5-afec-6de76a1bbfaeSPL set ID c34e0abf-02d8-4dee-a89b-3f61ab593dc3UNII 5EF0HWI5WU, VB06AV5US8, ZW3Z11D0JV, 11E6VI8VEG, WQZ3G9PF0H, 2E32821G6I, G0R4UBI2ZZ, 91GQH8I5F7, 324Y4038G2, 8E272251DIUPC 0363113701616
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
N444911046701followed by a unit qualifier and the quantityPackage 44911-0467-01. 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: May temporarily relieve mild ear disorders with soreness, sticking pain in ear, and minor swelling of the ear with redness.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Excerpt only. Read the full label for complete information.
About NDC 44911-0467
- What is NDC 44911-0467?
- 44911-0467 is the product NDC for Ototone, Baptisia tinctoria root 3 [hp_X]/mL + 9 more ingredients liquid, listed with the FDA by Energique, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ototone (Baptisia Tinctoria, Echinacea (Angustifolia), Hydrastis Canadensis, Phytolacca Decandra, Belladonna, Calcarea Carbonica, Chamomilla, Ferrum Phosphoricum, Mercurius Solubilis, Pulsatilla (Pratensis)).
- What is the active ingredient?
- Baptisia tinctoria root, Echinacea angustifolia whole, Goldenseal, Phytolacca americana root, Atropa belladonna, Oyster shell calcium carbonate, Crude, Matricaria chamomilla whole, Ferrosoferric phosphate, Mercurius solubilis, Pulsatilla pratensis whole.
- Who is the labeler?
- Energique, Inc., NDC labeler code 44911. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ototone?
- 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.