Over-the-counter drug · UNAPPROVED HOMEOPATHIC
Otoflam HP NDC 44911-0513
Atropa belladonna whole 30 [hp_X]/mL + 9 more ingredients · Liquid · Oral · Energique, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 44911-0513-1 | 4491105130144911051301 | 30 mL in 1 BOTTLE, DROPPER (44911-0513-1)Marketed from Oct 3, 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)
- Otoflam HPSuffix: HP
- Generic name (nonproprietary)
- belladonna, conium maculatum, dulcamara, ferrum phosphoricum, hepar sulphuris calcareum, kali bichromicum, mercurius solubilis, pulsatilla (pratensis), silicea, chamomilla.
- Active ingredients
- Atropa belladonna whole — 30 [hp_X]/mLConium maculatum flowering top — 30 [hp_X]/mLSolanum dulcamara top — 30 [hp_X]/mLFerrosoferric phosphate — 30 [hp_X]/mLCalcium sulfide — 30 [hp_X]/mLPotassium dichromate — 30 [hp_X]/mLMercurius solubilis — 30 [hp_X]/mLPulsatilla pratensis whole — 30 [hp_X]/mLSilicon dioxide — 30 [hp_X]/mLMatricaria chamomilla whole — 30 [hp_C]/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 44911-0513_b1b1bae2-148d-43f0-a7fe-f35c19a1bd31SPL ID b1b1bae2-148d-43f0-a7fe-f35c19a1bd31SPL set ID 76c6b494-43d1-4508-bea4-4f9026b4a5faUNII DSV74G1P2J, Q28R5GF371, KPS1B1162N, 91GQH8I5F7, 1MBW07J51Q, T4423S18FM, 324Y4038G2, 8E272251DI, ETJ7Z6XBU4, G0R4UBI2ZZ
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
N444911051301followed by a unit qualifier and the quantityPackage 44911-0513-01. 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 AND USAGE: May temporarily relieve ear pain and swelling.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Excerpt only. Read the full label for complete information.
About NDC 44911-0513
- What is NDC 44911-0513?
- 44911-0513 is the product NDC for Otoflam HP, Atropa belladonna whole 30 [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?
- Otoflam HP (Belladonna, Conium Maculatum, Dulcamara, Ferrum Phosphoricum, Hepar Sulphuris Calcareum, Kali Bichromicum, Mercurius Solubilis, Pulsatilla (Pratensis), Silicea, Chamomilla.).
- What is the active ingredient?
- Atropa belladonna whole, Conium maculatum flowering top, Solanum dulcamara top, Ferrosoferric phosphate, Calcium sulfide, Potassium dichromate, Mercurius solubilis, Pulsatilla pratensis whole, Silicon dioxide, Matricaria chamomilla 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 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, hepar sulphuris calcareum, kali bichromicum, mercurius solubilis, pulsatilla (vulgaris), silicea, chamomilla | Atropa belladonna 30 [hp_X]/mL + 8 more ingredients | LiquidOral | BioActive Nutritional, Inc. | 43857-0034 | 43857-0034-01 |