Over-the-counter drug · UNAPPROVED HOMEOPATHIC
Ear NDC 43857-0539
Baptisia tinctoria root 3 [hp_X]/mL + 9 more ingredients · Liquid · Oral · BioActive Nutritional, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43857-0539-1 | 4385705390143857053901 | 30 mL in 1 BOTTLE, DROPPER (43857-0539-1)Marketed from Oct 24, 2019 |
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)
- Ear
- Generic name (nonproprietary)
- baptisia tinctoria, echinacea (angustifolia), phytolacca decandra, hydrastis canadensis, capsicum annuum, chamomilla, ferrum phosphoricum, kali muriaticum, plantago major, pulsatilla (pratensis)
- Active ingredients
- Baptisia tinctoria root — 3 [hp_X]/mLEchinacea angustifolia whole — 3 [hp_X]/mLPhytolacca americana root — 4 [hp_X]/mLGoldenseal — 5 [hp_X]/mLCapsicum — 12 [hp_X]/mLMatricaria chamomilla whole — 12 [hp_X]/mLFerrosoferric phosphate — 12 [hp_X]/mLPotassium chloride — 12 [hp_X]/mLPlantago major whole — 12 [hp_X]/mLPulsatilla pratensis whole — 12 [hp_X]/mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- BioActive Nutritional, Inc.NDC labeler code 43857
- Product type
- Over-the-counter drug
- Marketing category
- Unapproved homeopathic
- Marketing start
- Listing expires
- Other FDA classes
- Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Dietary Proteins (Chemical structure)Increased Histamine Release (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Osmotic Activity (Mechanism)Plant Proteins (Chemical structure)Potassium Compounds (Chemical structure)Vegetable Proteins (Chemical structure)
- Identifiers
- Product ID 43857-0539_64379f2e-0201-42b6-924d-a8d1ee244531SPL ID 64379f2e-0201-42b6-924d-a8d1ee244531SPL set ID 82774eed-a906-4a19-86d9-05ea1462bd61UNII 5EF0HWI5WU, VB06AV5US8, 11E6VI8VEG, ZW3Z11D0JV, 00UK7646FG, G0R4UBI2ZZ, 91GQH8I5F7, 660YQ98I10, W2469WNO6U, 8E272251DIUPC 0210184341626
- Pharmacologic class
- Non-Standardized Food Allergenic Extract; Non-Standardized Plant Allergenic Extract; 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 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
N443857053901followed by a unit qualifier and the quantityPackage 43857-0539-01. 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)
USES: For temporary relief of earache with soreness, sticking pain in ears, 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 43857-0539
- What is NDC 43857-0539?
- 43857-0539 is the product NDC for Ear, Baptisia tinctoria root 3 [hp_X]/mL + 9 more ingredients liquid, listed with the FDA by BioActive Nutritional, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ear (Baptisia Tinctoria, Echinacea (Angustifolia), Phytolacca Decandra, Hydrastis Canadensis, Capsicum Annuum, Chamomilla, Ferrum Phosphoricum, Kali Muriaticum, Plantago Major, Pulsatilla (Pratensis)).
- What is the active ingredient?
- Baptisia tinctoria root, Echinacea angustifolia whole, Phytolacca americana root, Goldenseal, Capsicum, Matricaria chamomilla whole, Ferrosoferric phosphate, Potassium chloride, Plantago major whole, Pulsatilla pratensis whole.
- Who is the labeler?
- BioActive Nutritional, Inc., NDC labeler code 43857. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ear?
- 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.