D-58

Product NDC
58264-0058
11-digit product format
582640058
Labeler code
58264
Product ID
58264-0058_2b9ecbda-7106-d64a-e063-6294a90aac9e
Type
HUMAN OTC DRUG
Nonproprietary name
adonis vernalis, convallaria majalis, helleborus niger root, digitalis, crataegus laevigata fruit, and drimia maritima bulb
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
ADONIS VERNALIS; CONVALLARIA MAJALIS; CRATAEGUS LAEVIGATA FRUIT; DIGITALIS; DRIMIA MARITIMA BULB; HELLEBORUS NIGER ROOT
Active strength
2; 2; 1; 4; 4; 4 [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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
D-58
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADONIS VERNALIS2 [hp_X]/mL
CONVALLARIA MAJALIS2 [hp_X]/mL
CRATAEGUS LAEVIGATA FRUIT1 [hp_X]/mL
DIGITALIS4 [hp_X]/mL
DRIMIA MARITIMA BULB4 [hp_X]/mL
HELLEBORUS NIGER ROOT4 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDX3ZNI25WK, QHH4HVF5QE, D5RZ7MF1YF, F1T8QT9U8B, 3629601H5D, 608DGJ6815

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0058-12022-06-03C16284748780-19d75b9d0-aae3-f424-e053-dadaa90a57ceD-58
58264-0058-12020-01-31C16284748780-19d75b9d0-aae3-f424-e053-dadaa90a57ceD-58

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0058-1D-5829.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0058D-58 (ADONIS VERNALIS, CONVALLARIA MAJALIS, HELLEBORUS NIGER ROOT, DIGITALIS, CRATAEGUS LAEVIGATA FRUIT, AND DRIMIA MARITIMA BULB) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_e73d5830-1f04-478b-9178-63dc104c4a9c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0058-15826400580129.57 mL in 1 BOTTLE, GLASS (58264-0058-1) 29.57 ml1990-01-010000-00-00NoNoCurrent