D-55

Product NDC
58264-0055
11-digit product format
582640055
Labeler code
58264
Product ID
58264-0055_2b9ec8dd-73b1-e366-e063-6394a90ae792
Type
HUMAN OTC DRUG
Nonproprietary name
Comfrey root, Arnica montana, Calendula officinalis flowering top, Echinacea angustifolia, Hamamelis virginiana root bark/stem bark, Atropa Belladonna, Ruta graveolens flowering top, and Toxicodendron pubescens leaf
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
ARNICA MONTANA; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF
Active strength
3; 4; 3; 6; 3; 4; 6; 6 [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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
D-55
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA3 [hp_X]/mL
ATROPA BELLADONNA4 [hp_X]/mL
CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]/mL
COMFREY ROOT6 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA3 [hp_X]/mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK4 [hp_X]/mL
RUTA GRAVEOLENS FLOWERING TOP6 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF6 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO80TY208ZW, WQZ3G9PF0H, 18E7415PXQ, M9VVZ08EKQ, VB06AV5US8, T7S323PKJS, N94C2U587S, 6IO182RP7A

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0055-12022-06-03C16284748780-19d75b9d0-7e6d-f424-e053-dadaa90a57ceD-55
58264-0055-12020-01-31C16284748780-19d75b9d0-7e6d-f424-e053-dadaa90a57ceD-55

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0055-1D-5529.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0055D-55 (COMFREY ROOT, ARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING TOP, ECHINACEA ANGUSTIFOLIA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ATROPA BELLADONNA, RUTA GRAVEOLENS FLOWERING TOP, AND TOXICODENDRON PUBESCENS LEAF) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_1a316983-a023-4174-9aef-9e268a5799c1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0055-15826400550129.57 mL in 1 BOTTLE, GLASS (58264-0055-1) 29.57 ml1990-01-010000-00-00NoNoCurrent