Home NDC 57520-0371 Otoflam
Product NDC 57520-0371
11-digit product format 575200371
Labeler code 57520
Product ID 57520-0371_df57e1cc-7df6-4fd3-b61d-626b2bab9ee5
Type HUMAN OTC DRUG
Nonproprietary name Belladonna , Conium maculatum, Dulcamara, Ferrum phosphoricum, Hepar sulphuris calcareum, Kali bichromicum, mercurius solubilis, Pulsatilla, Silicea, Chamonilla
Dosage form LIQUID
Route ORAL
Labeler Apotheca, Company
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2010-06-08
Marketing end 2022-09-09
Substance ATROPA BELLADONNA; CALCIUM SULFIDE; CONIUM MACULATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SILICON DIOXIDE; SOLANUM DULCAMARA TOP
Active strength 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 0000-00-00
Current FDA listing Historical FDA.report record 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 · 34 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 57520-0371-1 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 57520-0371-1 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 57520-0371-1 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 57520-0371-1 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 57520-0371-1 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 57520-0371-1 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 57520-0371-1 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 57520-0371-1 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 57520-0371-1 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 57520-0371-1 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 57520-0371-1 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 57520-0371-1 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 57520-0371-1 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 57520-0371-1 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 57520-0371-1 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 57520-0371-1 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 57520-0371-1 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ATROPA BELLADONNA ACTIVE INGREDIENT WQZ3G9PF0H OTOFLAM (BELLADONNA , CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA) LIQUID [APOTHECA, COMPANY] 1 CALCIUM SULFIDE ACTIVE INGREDIENT 1MBW07J51Q OTOFLAM (BELLADONNA , CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA) LIQUID [APOTHECA, COMPANY] 1 CONIUM MACULATUM FLOWERING TOP ACTIVE INGREDIENT Q28R5GF371 OTOFLAM (BELLADONNA , CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA) LIQUID [APOTHECA, COMPANY] 1 FERRUM PHOSPHORICUM ACTIVE INGREDIENT 91GQH8I5F7 OTOFLAM (BELLADONNA , CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA) LIQUID [APOTHECA, COMPANY] 1 MATRICARIA RECUTITA ACTIVE INGREDIENT G0R4UBI2ZZ OTOFLAM (BELLADONNA , CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA) LIQUID [APOTHECA, COMPANY] 1 MERCURIUS SOLUBILIS ACTIVE INGREDIENT 324Y4038G2 OTOFLAM (BELLADONNA , CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA) LIQUID [APOTHECA, COMPANY] 1 POTASSIUM DICHROMATE ACTIVE INGREDIENT T4423S18FM OTOFLAM (BELLADONNA , CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA) LIQUID [APOTHECA, COMPANY] 1 PULSATILLA VULGARIS ACTIVE INGREDIENT I76KB35JEV OTOFLAM (BELLADONNA , CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA) LIQUID [APOTHECA, COMPANY] 1 SILICON DIOXIDE ACTIVE INGREDIENT ETJ7Z6XBU4 OTOFLAM (BELLADONNA , CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA) LIQUID [APOTHECA, COMPANY] 1 SOLANUM DULCAMARA TOP ACTIVE INGREDIENT KPS1B1162N OTOFLAM (BELLADONNA , CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA) LIQUID [APOTHECA, COMPANY] 1 ATROPA BELLADONNA ACTIVE MOIETY WQZ3G9PF0H OTOFLAM (BELLADONNA , CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA) LIQUID [APOTHECA, COMPANY] 1 CALCIUM CATION ACTIVE MOIETY 2M83C4R6ZB OTOFLAM (BELLADONNA , CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA) LIQUID [APOTHECA, COMPANY] 1 CONIUM MACULATUM FLOWERING TOP ACTIVE MOIETY Q28R5GF371 OTOFLAM (BELLADONNA , CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA) LIQUID [APOTHECA, COMPANY] 1 FERRUM PHOSPHORICUM ACTIVE MOIETY 91GQH8I5F7 OTOFLAM (BELLADONNA , CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA) LIQUID [APOTHECA, COMPANY] 1 MATRICARIA RECUTITA ACTIVE MOIETY G0R4UBI2ZZ OTOFLAM (BELLADONNA , CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA) LIQUID [APOTHECA, COMPANY] 1 MERCURIUS SOLUBILIS ACTIVE MOIETY 324Y4038G2 OTOFLAM (BELLADONNA , CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA) LIQUID [APOTHECA, COMPANY] 1 POTASSIUM CATION ACTIVE MOIETY 295O53K152 OTOFLAM (BELLADONNA , CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA) LIQUID [APOTHECA, COMPANY] 1 PULSATILLA VULGARIS ACTIVE MOIETY I76KB35JEV OTOFLAM (BELLADONNA , CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA) LIQUID [APOTHECA, COMPANY] 1 SILICON ACTIVE MOIETY Z4152N8IUI OTOFLAM (BELLADONNA , CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA) LIQUID [APOTHECA, COMPANY] 1 SOLANUM DULCAMARA TOP ACTIVE MOIETY KPS1B1162N OTOFLAM (BELLADONNA , CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA) LIQUID [APOTHECA, COMPANY] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M OTOFLAM (BELLADONNA , CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA) LIQUID [APOTHECA, COMPANY] 1 WATER INACTIVE INGREDIENT 059QF0KO0R OTOFLAM (BELLADONNA , CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA, SILICEA, CHAMONILLA) LIQUID [APOTHECA, COMPANY] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 57520-0371-1 57520037101 30 mL in 1 BOTTLE, DROPPER (57520-0371-1) 30 ml 2010-06-08 2022-09-09 No No Current