Otoflam HP

Product NDC
44911-0051
Requested package NDC
44911-0051-1
11-digit product format
449110051
Labeler code
44911
Product ID
44911-0051_779e2152-a44e-4bf8-bee2-7cf317282ad6
Type
HUMAN OTC DRUG
Nonproprietary name
Belladonna, Conium Maculatum, Dulcamara, Ferrum Phosphoricum, Hepar Sulphuris Calcareum, Kali Bichromicum
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2012-11-26
Marketing end
2023-01-24
Substance
ATROPA BELLADONNA WHOLE; CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; POTASSIUM DICHROMATE; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; SILICON DIOXIDE; MATRICARIA RECUTITA
Active strength
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
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage44911-005144911-0051-1DDiscontinued by firm2026-10-12

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0051-12020-04-28C16284748780-19d75b9cf-e41d-f424-e053-dadaa90a57ceDrug Facts
44911-0051-12020-01-31C16284748780-19d75b9cf-e41d-f424-e053-dadaa90a57ceDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATROPA BELLADONNA WHOLEACTIVE INGREDIENTDSV74G1P2JOTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM) LIQUID [ENERGIQUE, INC.]1
CALCIUM SULFIDEACTIVE INGREDIENT1MBW07J51QOTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM) LIQUID [ENERGIQUE, INC.]1
CONIUM MACULATUM FLOWERING TOPACTIVE INGREDIENTQ28R5GF371OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM) LIQUID [ENERGIQUE, INC.]1
FERROSOFERRIC PHOSPHATEACTIVE INGREDIENT91GQH8I5F7OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM) LIQUID [ENERGIQUE, INC.]1
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZOTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM) LIQUID [ENERGIQUE, INC.]1
MERCURIUS SOLUBILISACTIVE INGREDIENT324Y4038G2OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM) LIQUID [ENERGIQUE, INC.]1
POTASSIUM DICHROMATEACTIVE INGREDIENTT4423S18FMOTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM) LIQUID [ENERGIQUE, INC.]1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEVOTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM) LIQUID [ENERGIQUE, INC.]1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU4OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM) LIQUID [ENERGIQUE, INC.]1
SOLANUM DULCAMARA TOPACTIVE INGREDIENTKPS1B1162NOTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM) LIQUID [ENERGIQUE, INC.]1
ATROPA BELLADONNA WHOLEACTIVE MOIETYDSV74G1P2JOTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM) LIQUID [ENERGIQUE, INC.]1
CALCIUM SULFIDEACTIVE MOIETY1MBW07J51QOTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM) LIQUID [ENERGIQUE, INC.]1
COLLOIDAL SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU4OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM) LIQUID [ENERGIQUE, INC.]1
CONIUM MACULATUM FLOWERING TOPACTIVE MOIETYQ28R5GF371OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM) LIQUID [ENERGIQUE, INC.]1
DICHROMATE IONACTIVE MOIETY9LKY4BFN2VOTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM) LIQUID [ENERGIQUE, INC.]1
FERROSOFERRIC PHOSPHATEACTIVE MOIETY91GQH8I5F7OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM) LIQUID [ENERGIQUE, INC.]1
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZOTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM) LIQUID [ENERGIQUE, INC.]1
MERCURIUS SOLUBILISACTIVE MOIETY324Y4038G2OTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM) LIQUID [ENERGIQUE, INC.]1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEVOTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM) LIQUID [ENERGIQUE, INC.]1
SOLANUM DULCAMARA TOPACTIVE MOIETYKPS1B1162NOTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM) LIQUID [ENERGIQUE, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MOTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM) LIQUID [ENERGIQUE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0ROTOFLAM HP (BELLADONNA, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM) LIQUID [ENERGIQUE, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0051-14491100510130 mL in 1 BOTTLE, DROPPER (44911-0051-1) 30 ml2012-11-262023-01-24NoNoCurrent