Home NDC 55714-2453-1 Headache
Product NDC 55714-2453
Requested package NDC 55714-2453-1
11-digit product format 557142453
Labeler code 55714
Product ID 55714-2453_b557ee00-296b-1e4d-e053-2995a90a85b5
Type HUMAN OTC DRUG
Nonproprietary name Elaps corallinus, Arsenicum alb., Belladonna, Bryonia, Carduus benedictus, Cimicifuga, Coffea cruda, Convallaria, Crotalus horridus, Digitalis, Gelsemium, Glonoinum, Ignatia, Lachesis, Merc. viv., Naja, Nux vom., Phosphorus, Rhus toxicodendron, Sanguinaria, Secale, Vipera berus, Apis mel., Hypericum, Thuja occ..
Dosage form LIQUID
Route ORAL
Labeler Newton Laboratories, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2019-01-31
Marketing end 0000-00-00
Substance MICRURUS CORALLINUS VENOM; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; BLACK COHOSH; ARABICA COFFEE BEAN; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; MERCURY; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; CLAVICEPS PURPUREA SCLEROTIUM; VIPERA BERUS VENOM; APIS MELLIFERA; HYPERICUM PERFORATUM; THUJA OCCIDENTALIS LEAFY TWIG
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_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_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag No
Listing certified through 2021-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55714-2453 55714-2453-1 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55714-2453 55714-2453-1 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55714-2453-1 Headache 30 mL in 1 BOTTLE, GLASS LIQUID 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55714-2453 HEADACHE (ELAPS CORALLINUS, ARSENICUM ALB., BELLADONNA, BRYONIA, CARDUUS BENEDICTUS, CIMICIFUGA, COFFEA CRUDA, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, GELSEMIUM, GLONOINUM, IGNATIA, LACHESIS, MERC. VIV., NAJA, NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, SANGUINARIA, SECALE, VIPERA BERUS, APIS MEL., HYPERICUM, THUJA OCC..) LIQUID [NEWTON LABORATORIES, INC.] 2 Legacy NDC, 1 package rows 20201201_9ab2a6e7-4e4f-e232-e053-2a95a90a66cb.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55714-2453-1 55714245301 30 mL in 1 BOTTLE, GLASS (55714-2453-1) 30 ml 2019-01-31 0000-00-00 No No Current