Home NDC 44911-0513 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; CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; POTASSIUM DICHROMATE; MERCURIUS SOLUBILIS; PULSATILLA PRATENSIS WHOLE; SILICON DIOXIDE; MATRICARIA CHAMOMILLA WHOLE
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_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 44911-0513-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 44911-0513-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 44911-0513-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 44911-0513-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 44911-0513-1 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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_X]/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_C]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 10 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
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, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SILICEA, CHAMOMILLA. Energique, Inc. 76c6b494-43d1-4508-bea4-4f9026b4a5fa 2024-10-29 Warnings Exact identifier ndc (product): 44911-0513
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