Over-the-counter drug · UNAPPROVED HOMEOPATHIC
Otoflam HP NDC 43857-0034
Atropa belladonna 30 [hp_X]/mL + 8 more ingredients · Liquid · Oral · BioActive Nutritional, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43857-0034-1 | 4385700340143857003401 | 30 mL in 1 BOTTLE, DROPPER (43857-0034-1)Marketed from Apr 4, 2017 |
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)
- Otoflam HPSuffix: HP
- Generic name (nonproprietary)
- belladonna, conium maculatum, dulcamara, hepar sulphuris calcareum, kali bichromicum, mercurius solubilis, pulsatilla (vulgaris), silicea, chamomilla
- Active ingredients
- Atropa belladonna — 30 [hp_X]/mLConium maculatum flowering top — 30 [hp_X]/mLSolanum dulcamara top — 30 [hp_X]/mLCalcium sulfide — 30 [hp_X]/mLPotassium dichromate — 30 [hp_X]/mLMercurius solubilis — 30 [hp_X]/mLPulsatilla vulgaris — 30 [hp_X]/mLSilicon dioxide — 30 [hp_X]/mLMatricaria recutita — 30 [hp_C]/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
- Identifiers
- Product ID 43857-0034_3200f43d-2588-4183-9a3c-753f9b1f4806SPL ID 3200f43d-2588-4183-9a3c-753f9b1f4806SPL set ID 12f1ef62-93f3-45b8-885d-1b82f85a8355UNII WQZ3G9PF0H, Q28R5GF371, KPS1B1162N, 1MBW07J51Q, T4423S18FM, 324Y4038G2, I76KB35JEV, ETJ7Z6XBU4, G0R4UBI2ZZUPC 0210184341732
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
N443857003401followed by a unit qualifier and the quantityPackage 43857-0034-01. 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 symptoms due to inflammation of the ear.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Excerpt only. Read the full label for complete information.
About NDC 43857-0034
- What is NDC 43857-0034?
- 43857-0034 is the product NDC for Otoflam HP, Atropa belladonna 30 [hp_X]/mL + 8 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?
- Otoflam HP (Belladonna, Conium Maculatum, Dulcamara, Hepar Sulphuris Calcareum, Kali Bichromicum, Mercurius Solubilis, Pulsatilla (Vulgaris), Silicea, Chamomilla).
- What is the active ingredient?
- Atropa belladonna, Conium maculatum flowering top, Solanum dulcamara top, Calcium sulfide, Potassium dichromate, Mercurius solubilis, Pulsatilla vulgaris, Silicon dioxide, Matricaria recutita.
- 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 Otoflam HP?
- 1 other product NDC are listed under this name. See all Otoflam HP NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Otoflam HP products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Otoflam HPbelladonna, conium maculatum, dulcamara, ferrum phosphoricum, hepar sulphuris calcareum, kali bichromicum, mercurius solubilis, pulsatilla (pratensis), silicea, chamomilla. | Atropa belladonna whole 30 [hp_X]/mL + 9 more ingredients | LiquidOral | Energique, Inc. | 44911-0513 | 44911-0513-01 |