Otoflam
- Product NDC
- 44911-0513
- 11-digit product format
- 449110513
- Labeler code
- 44911
- Product ID
- 44911-0513_b1b1bae2-148d-43f0-a7fe-f35c19a1bd31
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Belladonna, Conium Maculatum, Dulcamara, Ferrum Phosphoricum, Hepar Sulphuris Calcareum, Kali Bichromicum, Mercurius Solubilis, Pulsatilla (Pratensis), Silicea, Chamomilla.
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Energique, Inc.
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2019-10-03
- Substance
- ATROPA BELLADONNA WHOLE; CALCIUM SULFIDE; CONIUM MACULATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; MATRICARIA CHAMOMILLA WHOLE; MERCURIUS SOLUBILIS; POTASSIUM DICHROMATE; PULSATILLA PRATENSIS WHOLE; SILICON DIOXIDE; SOLANUM DULCAMARA TOP
- Active strength
- 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Otoflam
- Brand name suffix
- HP
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATROPA BELLADONNA WHOLE | 30 [hp_X]/mL |
| CONIUM MACULATUM FLOWERING TOP | 30 [hp_X]/mL |
| SOLANUM DULCAMARA TOP | 30 [hp_X]/mL |
| FERROSOFERRIC PHOSPHATE | 30 [hp_X]/mL |
| CALCIUM SULFIDE | 30 [hp_C]/mL |
| POTASSIUM DICHROMATE | 30 [hp_X]/mL |
| MERCURIUS SOLUBILIS | 30 [hp_X]/mL |
| PULSATILLA PRATENSIS WHOLE | 30 [hp_X]/mL |
| SILICON DIOXIDE | 30 [hp_X]/mL |
| MATRICARIA CHAMOMILLA WHOLE | 30 [hp_X]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | DSV74G1P2J, Q28R5GF371, KPS1B1162N, 91GQH8I5F7, 1MBW07J51Q, T4423S18FM, 324Y4038G2, 8E272251DI, ETJ7Z6XBU4, G0R4UBI2ZZ |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 44911-0513-1 | OtoflamHP | 30 mL in 1 BOTTLE, DROPPER | LIQUID | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 44911-0513 | OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SILICEA, CHAMOMILLA.) LIQUID [ENERGIQUE, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20241031_76c6b494-43d1-4508-bea4-4f9026b4a5fa.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 44911-0513-1 | 44911051301 | 30 mL in 1 BOTTLE, DROPPER (44911-0513-1) | 30 ml | 2019-10-03 | 0000-00-00 | No | No | Current |