Home NDC 43857-0034 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 CONIUM MACULATUM FLOWERING TOP 30 [hp_X]/mL SOLANUM DULCAMARA TOP 30 [hp_X]/mL CALCIUM SULFIDE 30 [hp_C]/mL POTASSIUM DICHROMATE 30 [hp_X]/mL MERCURIUS SOLUBILIS 30 [hp_X]/mL PULSATILLA VULGARIS 30 [hp_X]/mL SILICON DIOXIDE 30 [hp_X]/mL MATRICARIA RECUTITA 30 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 9 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Otoflam HP BELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), SILICEA, CHAMOMILLA BioActive Nutritional, Inc. 12f1ef62-93f3-45b8-885d-1b82f85a8355 2026-03-17 Warnings Exact identifier ndc (product): 43857-0034
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