EPI Formula

Product NDC
83027-0139
11-digit product format
830270139
Labeler code
83027
Product ID
83027-0139_7b39c527-2c04-4a2b-9099-455505a8d26a
Type
HUMAN OTC DRUG
Nonproprietary name
Belladonna, Hyoscyamus Niger, Asterias Rubens, Calcarea Carbonica, Oenanthe Crocata,Cicuta Virosa, Cuprum Metallicum
Dosage form
SPRAY
Route
ORAL
Labeler
Nutritional Specialties, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-05-31
Substance
ATROPA BELLADONNA; HYOSCYAMUS NIGER; ASTERIAS RUBENS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; OENANTHE CROCATA ROOT; CICUTA VIROSA ROOT; COPPER
Active strength
4; 4; 8; 10; 10; 12; 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
Listing certified through
2026-12-31
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPA BELLADONNA4 [hp_X]/mL
HYOSCYAMUS NIGER4 [hp_X]/mL
ASTERIAS RUBENS8 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE10 [hp_X]/mL
OENANTHE CROCATA ROOT10 [hp_X]/mL
CICUTA VIROSA ROOT12 [hp_X]/mL
COPPER12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WQZ3G9PF0HInternal UNII lookup
4WRK2153H3Internal UNII lookup
A7FYY9Q742Internal UNII lookup
2E32821G6IInternal UNII lookup
6FS6FK5S8NInternal UNII lookup
YEA9P21S8NInternal UNII lookup
789U1901C5Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2290c23a-119d-4b27-bc3f-0e1fdfa4e9dcAvailable on FDA.report

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
83027-0139-1EPI Formula60 mL in 1 BOTTLE, SPRAYSPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83027-0139EPI FORMULA (BELLADONNA, HYOSCYAMUS NIGER, ASTERIAS RUBENS, CALCAREA CARBONICA, OENANTHE CROCATA,CICUTA VIROSA, CUPRUM METALLICUM) SPRAY [NUTRITIONAL SPECIALTIES, INC.]1Current NDC, 1 package rows20240606_2290c23a-119d-4b27-bc3f-0e1fdfa4e9dc.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EPI FormulaBELLADONNA, HYOSCYAMUS NIGER, ASTERIAS RUBENS, CALCAREA CARBONICA, OENANTHE CROCATA,CICUTA VIROSA, CUPRUM METALLICUMNutritional Specialties, Inc.2290c23a-119d-4b27-bc3f-0e1fdfa4e9dc2024-05-31WarningsExact identifier
ndc (product): 83027-0139

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83027-0139-18302701390160 mL in 1 BOTTLE, SPRAY (83027-0139-1) 60 ml2024-05-31NoNoCurrent