Home NDC 55758-001 DoloEar
Product NDC 55758-001
11-digit product format 557580001
Labeler code 55758
Product ID 55758-001_d21a2c9d-1a4b-b53a-e053-2a95a90a177f
Type HUMAN OTC DRUG
Nonproprietary name atropa belladonna, apis mellifera, aristolochia clematitis root, matricaria recutita, lachesis muta venom, and thuja Occidentalis leafy twig
Dosage form SOLUTION/ DROPS
Route AURICULAR (OTIC)
Labeler Pharmadel LLC
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2013-05-23
Marketing end 0000-00-00
Substance ATROPA BELLADONNA; APIS MELLIFERA; ARISTOLOCHIA CLEMATITIS ROOT; MATRICARIA RECUTITA; LACHESIS MUTA VENOM; THUJA OCCIDENTALIS LEAFY TWIG
Active strength 6 [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL
NDC exclude flag No
Listing certified through 2022-12-31
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 · 4 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55758-001-15 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55758-001-15 f5e01cc5f278…a2eaf40c39c3…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Apis Mellifera ACTIVE INGREDIENT 7S82P3R43Z DOLOEAR (ATROPA BELLADONNA, APIS MELLIFERA, ARISTOLOCHIA CLEMATITIS ROOT, MATRICARIA RECUTITA, LACHESIS MUTA VENOM, AND THUJA OCCIDENTALIS LEAFY TWIG) SOLUTION/ DROPS [PHARMADEL LLC] 1 Aristolochia Clematitis Root ACTIVE INGREDIENT ZY0NX0W00D DOLOEAR (ATROPA BELLADONNA, APIS MELLIFERA, ARISTOLOCHIA CLEMATITIS ROOT, MATRICARIA RECUTITA, LACHESIS MUTA VENOM, AND THUJA OCCIDENTALIS LEAFY TWIG) SOLUTION/ DROPS [PHARMADEL LLC] 1 Atropa Belladonna ACTIVE INGREDIENT WQZ3G9PF0H DOLOEAR (ATROPA BELLADONNA, APIS MELLIFERA, ARISTOLOCHIA CLEMATITIS ROOT, MATRICARIA RECUTITA, LACHESIS MUTA VENOM, AND THUJA OCCIDENTALIS LEAFY TWIG) SOLUTION/ DROPS [PHARMADEL LLC] 1 Lachesis Muta Venom ACTIVE INGREDIENT VSW71SS07I DOLOEAR (ATROPA BELLADONNA, APIS MELLIFERA, ARISTOLOCHIA CLEMATITIS ROOT, MATRICARIA RECUTITA, LACHESIS MUTA VENOM, AND THUJA OCCIDENTALIS LEAFY TWIG) SOLUTION/ DROPS [PHARMADEL LLC] 1 Matricaria Recutita ACTIVE INGREDIENT G0R4UBI2ZZ DOLOEAR (ATROPA BELLADONNA, APIS MELLIFERA, ARISTOLOCHIA CLEMATITIS ROOT, MATRICARIA RECUTITA, LACHESIS MUTA VENOM, AND THUJA OCCIDENTALIS LEAFY TWIG) SOLUTION/ DROPS [PHARMADEL LLC] 1 Thuja Occidentalis Leafy Twig ACTIVE INGREDIENT 1NT28V9397 DOLOEAR (ATROPA BELLADONNA, APIS MELLIFERA, ARISTOLOCHIA CLEMATITIS ROOT, MATRICARIA RECUTITA, LACHESIS MUTA VENOM, AND THUJA OCCIDENTALIS LEAFY TWIG) SOLUTION/ DROPS [PHARMADEL LLC] 1 Apis Mellifera ACTIVE MOIETY 7S82P3R43Z DOLOEAR (ATROPA BELLADONNA, APIS MELLIFERA, ARISTOLOCHIA CLEMATITIS ROOT, MATRICARIA RECUTITA, LACHESIS MUTA VENOM, AND THUJA OCCIDENTALIS LEAFY TWIG) SOLUTION/ DROPS [PHARMADEL LLC] 1 Aristolochia Clematitis Root ACTIVE MOIETY ZY0NX0W00D DOLOEAR (ATROPA BELLADONNA, APIS MELLIFERA, ARISTOLOCHIA CLEMATITIS ROOT, MATRICARIA RECUTITA, LACHESIS MUTA VENOM, AND THUJA OCCIDENTALIS LEAFY TWIG) SOLUTION/ DROPS [PHARMADEL LLC] 1 Atropa Belladonna ACTIVE MOIETY WQZ3G9PF0H DOLOEAR (ATROPA BELLADONNA, APIS MELLIFERA, ARISTOLOCHIA CLEMATITIS ROOT, MATRICARIA RECUTITA, LACHESIS MUTA VENOM, AND THUJA OCCIDENTALIS LEAFY TWIG) SOLUTION/ DROPS [PHARMADEL LLC] 1 Lachesis Muta Venom ACTIVE MOIETY VSW71SS07I DOLOEAR (ATROPA BELLADONNA, APIS MELLIFERA, ARISTOLOCHIA CLEMATITIS ROOT, MATRICARIA RECUTITA, LACHESIS MUTA VENOM, AND THUJA OCCIDENTALIS LEAFY TWIG) SOLUTION/ DROPS [PHARMADEL LLC] 1 Matricaria Recutita ACTIVE MOIETY G0R4UBI2ZZ DOLOEAR (ATROPA BELLADONNA, APIS MELLIFERA, ARISTOLOCHIA CLEMATITIS ROOT, MATRICARIA RECUTITA, LACHESIS MUTA VENOM, AND THUJA OCCIDENTALIS LEAFY TWIG) SOLUTION/ DROPS [PHARMADEL LLC] 1 Thuja Occidentalis Leafy Twig ACTIVE MOIETY 1NT28V9397 DOLOEAR (ATROPA BELLADONNA, APIS MELLIFERA, ARISTOLOCHIA CLEMATITIS ROOT, MATRICARIA RECUTITA, LACHESIS MUTA VENOM, AND THUJA OCCIDENTALIS LEAFY TWIG) SOLUTION/ DROPS [PHARMADEL LLC] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX DOLOEAR (ATROPA BELLADONNA, APIS MELLIFERA, ARISTOLOCHIA CLEMATITIS ROOT, MATRICARIA RECUTITA, LACHESIS MUTA VENOM, AND THUJA OCCIDENTALIS LEAFY TWIG) SOLUTION/ DROPS [PHARMADEL LLC] 1 Water INACTIVE INGREDIENT 059QF0KO0R DOLOEAR (ATROPA BELLADONNA, APIS MELLIFERA, ARISTOLOCHIA CLEMATITIS ROOT, MATRICARIA RECUTITA, LACHESIS MUTA VENOM, AND THUJA OCCIDENTALIS LEAFY TWIG) SOLUTION/ DROPS [PHARMADEL LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55758-001 DOLOEAR (ATROPA BELLADONNA, APIS MELLIFERA, ARISTOLOCHIA CLEMATITIS ROOT, MATRICARIA RECUTITA, LACHESIS MUTA VENOM, AND THUJA OCCIDENTALIS LEAFY TWIG) SOLUTION/ DROPS [PHARMADEL LLC] 3 Legacy NDC 20211202_677c111f-513b-4148-a954-2a801fa4ebcf.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55758-001-15 55758000115 15 mL in 1 BOTTLE, DROPPER (55758-001-15) 15 ml 2019-11-15 0000-00-00 No No Current