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
ASTERIAS RUBENS; ATROPA BELLADONNA; CICUTA VIROSA ROOT; COPPER; HYOSCYAMUS NIGER; OENANTHE CROCATA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE
Active strength
8; 4; 10; 12; 4; 10; 10 [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

Additional Listing Data#

Finished product
Yes
Brand name base
EPI Formula

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASTERIAS RUBENS8 [hp_X]/mL
ATROPA BELLADONNA4 [hp_X]/mL
CICUTA VIROSA ROOT10 [hp_X]/mL
COPPER12 [hp_X]/mL
HYOSCYAMUS NIGER4 [hp_X]/mL
OENANTHE CROCATA ROOT10 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE10 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA7FYY9Q742, WQZ3G9PF0H, YEA9P21S8N, 789U1901C5, 4WRK2153H3, 6FS6FK5S8N, 2E32821G6I

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83027-0002-1EPI Formula60 mL in 1 BOTTLE, SPRAYSPRAY602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83027-0002EPI FORMULA (BELLADONNA, HYOSCYAMUS NIGER, ASTERIAS RUBENS, CALCAREA CARBONICA, CICUTA VIROSA, OENANTHE CROCATA, CUPRUM METALLICUM) SPRAY [NUTRITIONAL SPECIALTIES, INC.]2Current NDC, 1 package rows20240606_2f4acf3d-09d7-4dcc-b23c-793b0e2d53b1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83027-0002-18302700020160 mL in 1 BOTTLE, SPRAY (83027-0002-1) 60 ml2023-03-242028-03-22NoNoHistorical