Home NDC 83027-0002 EPI Formula
Product NDC 83027-0002
11-digit product format 830270002
Labeler code 83027
Product ID 83027-0002_f1a5d931-3aad-4401-8694-7a88f36d420b
Type HUMAN OTC DRUG
Nonproprietary name Belladonna, Hyoscyamus Niger, Asterias Rubens, Calcarea Carbonica, Cicuta Virosa, Oenanthe Crocata, Cuprum Metallicum
Dosage form SPRAY
Route ORAL
Labeler Nutritional Specialties, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2023-03-24
Marketing end 2028-03-22
Substance ATROPA BELLADONNA; HYOSCYAMUS NIGER; ASTERIAS RUBENS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CICUTA VIROSA ROOT; OENANTHE CROCATA ROOT; COPPER
Active strength 4; 4; 8; 10; 10; 10; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE]
NDC exclude flag No
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base EPI Formula Active Ingredients# Ingredient, Strength table Ingredient Strength ATROPA BELLADONNA 4 [hp_X]/mL HYOSCYAMUS NIGER 4 [hp_X]/mL ASTERIAS RUBENS 8 [hp_X]/mL OYSTER SHELL CALCIUM CARBONATE, CRUDE 10 [hp_X]/mL CICUTA VIROSA ROOT 10 [hp_X]/mL OENANTHE CROCATA ROOT 10 [hp_X]/mL COPPER 12 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 7 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83027-0002-1 EPI Formula 60 mL in 1 BOTTLE, SPRAY SPRAY 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83027-0002 EPI FORMULA (BELLADONNA, HYOSCYAMUS NIGER, ASTERIAS RUBENS, CALCAREA CARBONICA, CICUTA VIROSA, OENANTHE CROCATA, CUPRUM METALLICUM) SPRAY [NUTRITIONAL SPECIALTIES, INC.] 2 Current NDC, 1 package rows 20240606_2f4acf3d-09d7-4dcc-b23c-793b0e2d53b1.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EPI Formula BELLADONNA, HYOSCYAMUS NIGER, ASTERIAS RUBENS, CALCAREA CARBONICA, CICUTA VIROSA, OENANTHE CROCATA, CUPRUM METALLICUM Nutritional Specialties, Inc. 2f4acf3d-09d7-4dcc-b23c-793b0e2d53b1 2024-06-05 Warnings Exact identifier ndc (product): 83027-0002
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 83027-0002-1 83027000201 60 mL in 1 BOTTLE, SPRAY (83027-0002-1) 60 ml 2023-03-24 2028-03-22 No No Historical