Home NDC 55758-327 DoloEar
Product NDC 55758-327
11-digit product format 557580327
Labeler code 55758
Product ID 55758-327_f05e347b-488f-35f5-e053-2995a90aeaa4
Type HUMAN OTC DRUG
Nonproprietary name Apis Melifica, Aristolochia Clematitis, Belladonna, Chamomilla, Lachesis Mutus, Thuja Occidentalis
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 APIS MELLIFERA; ARISTOLOCHIA CLEMATITIS ROOT; ATROPA BELLADONNA; LACHESIS MUTA VENOM; MATRICARIA CHAMOMILLA; 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
Pharmacologic classes Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 55758-327-15 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 55758-327-15 f5e01cc5f278…a2eaf40c39c3…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55758-327 DOLOEAR (APIS MELIFICA, ARISTOLOCHIA CLEMATITIS, BELLADONNA, CHAMOMILLA, LACHESIS MUTUS, THUJA OCCIDENTALIS) SOLUTION/ DROPS [PHARMADEL LLC] 8 Legacy NDC 20231114_cfbf183d-962b-2e66-e053-2995a90a12d5.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55758-327-15 55758032715 1 BOTTLE, DROPPER in 1 BOX (55758-327-15) > 15 mL in 1 BOTTLE, DROPPER 2013-05-23 0000-00-00 No No Current