Otoflam
- Product NDC
- 43857-0034
- 11-digit product format
- 438570034
- Labeler code
- 43857
- Product ID
- 43857-0034_3200f43d-2588-4183-9a3c-753f9b1f4806
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Belladonna, Conium Maculatum, Dulcamara, Hepar Sulphuris Calcareum, Kali Bichromicum, Mercurius Solubilis, Pulsatilla (Vulgaris), Silicea, Chamomilla
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- BioActive Nutritional, Inc.
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2012-07-13
- Substance
- ATROPA BELLADONNA; CALCIUM SULFIDE; CONIUM MACULATUM FLOWERING TOP; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SILICON DIOXIDE; SOLANUM DULCAMARA TOP
- Active strength
- 30; 30; 30; 30; 30; 30; 30; 30; 30 [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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Otoflam
- Brand name suffix
- HP
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATROPA BELLADONNA | 30 [hp_X]/mL |
| CALCIUM SULFIDE | 30 [hp_X]/mL |
| CONIUM MACULATUM FLOWERING TOP | 30 [hp_X]/mL |
| MATRICARIA RECUTITA | 30 [hp_C]/mL |
| MERCURIUS SOLUBILIS | 30 [hp_X]/mL |
| POTASSIUM DICHROMATE | 30 [hp_X]/mL |
| PULSATILLA VULGARIS | 30 [hp_X]/mL |
| SILICON DIOXIDE | 30 [hp_X]/mL |
| SOLANUM DULCAMARA TOP | 30 [hp_X]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WQZ3G9PF0H, 1MBW07J51Q, Q28R5GF371, G0R4UBI2ZZ, 324Y4038G2, T4423S18FM, I76KB35JEV, ETJ7Z6XBU4, KPS1B1162N |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43857-0034-1 | OtoflamHP | 30 mL in 1 BOTTLE, DROPPER | LIQUID | 30 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ATROPA BELLADONNA | ACTIVE INGREDIENT | WQZ3G9PF0H | OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA,) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 6 | |
| CALCIUM SULFIDE | ACTIVE INGREDIENT | 1MBW07J51Q | OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA,) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 6 | |
| CONIUM MACULATUM FLOWERING TOP | ACTIVE INGREDIENT | Q28R5GF371 | OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA,) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 6 | |
| MATRICARIA RECUTITA | ACTIVE INGREDIENT | G0R4UBI2ZZ | OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA,) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 6 | |
| MERCURIUS SOLUBILIS | ACTIVE INGREDIENT | 324Y4038G2 | OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA,) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 6 | |
| POTASSIUM DICHROMATE | ACTIVE INGREDIENT | T4423S18FM | OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA,) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 6 | |
| PULSATILLA VULGARIS | ACTIVE INGREDIENT | I76KB35JEV | OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA,) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 6 | |
| SILICON DIOXIDE | ACTIVE INGREDIENT | ETJ7Z6XBU4 | OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA,) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 6 | |
| SOLANUM DULCAMARA TOP | ACTIVE INGREDIENT | KPS1B1162N | OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA,) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 6 | |
| ATROPA BELLADONNA | ACTIVE MOIETY | WQZ3G9PF0H | OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA,) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 6 | |
| CALCIUM SULFIDE | ACTIVE MOIETY | 1MBW07J51Q | OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA,) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 6 | |
| CONIUM MACULATUM FLOWERING TOP | ACTIVE MOIETY | Q28R5GF371 | OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA,) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 6 | |
| DICHROMATE ION | ACTIVE MOIETY | 9LKY4BFN2V | OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA,) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 6 | |
| MATRICARIA RECUTITA | ACTIVE MOIETY | G0R4UBI2ZZ | OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA,) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 6 | |
| MERCURIUS SOLUBILIS | ACTIVE MOIETY | 324Y4038G2 | OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA,) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 6 | |
| PULSATILLA VULGARIS | ACTIVE MOIETY | I76KB35JEV | OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA,) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 6 | |
| SILICON DIOXIDE | ACTIVE MOIETY | ETJ7Z6XBU4 | OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA,) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 6 | |
| SOLANUM DULCAMARA TOP | ACTIVE MOIETY | KPS1B1162N | OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA,) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 6 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA,) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA,) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43857-0034 | OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), SILICEA, CHAMOMILLA) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20170407_12f1ef62-93f3-45b8-885d-1b82f85a8355.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43857-0034-1 | 43857003401 | 30 mL in 1 BOTTLE, DROPPER (43857-0034-1) | 30 ml | 2017-04-04 | 0000-00-00 | No | No | Current |