FDA.reportPublic FDA data

D-114

Product NDC
58264-0120
11-digit product format
582640120
Labeler code
58264
Product ID
58264-0120_2b9eda10-4e9e-e31e-e063-6394a90a53c6
Type
HUMAN OTC DRUG
Nonproprietary name
AlumInum metallicum, Ailanthus, Baptisia tinctoria, Fragaria vesca, Yoscyamus niger, Muriaticum acid
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-03-15
Substance
AILANTHUS ALTISSIMA FLOWERING TWIG; ALUMINUM; BAPTISIA TINCTORIA ROOT; FRAGARIA VESCA FRUIT; HYDROCHLORIC ACID; HYOSCYAMUS NIGER
Active strength
30; 30; 30; 30; 12; 30 [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-114
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AILANTHUS ALTISSIMA FLOWERING TWIG30 [hp_X]/mL
ALUMINUM30 [hp_X]/mL
BAPTISIA TINCTORIA ROOT30 [hp_X]/mL
FRAGARIA VESCA FRUIT30 [hp_X]/mL
HYDROCHLORIC ACID12 [hp_X]/mL
HYOSCYAMUS NIGER30 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8P29O5P7XU, CPD4NFA903, 5EF0HWI5WU, CG6IX3GCMU, QTT17582CB, 4WRK2153H3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0120-1D-11429.57 mL in 1 BOTTLE, GLASSSOLUTION29.572

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0120D-114 (ALUMINUM METALLICUM, AILANTHUS, BAPTISIA TINCTORIA, FRAGARIA VESCA, YOSCYAMUS NIGER, MURIATICUM ACID) SOLUTION [DNA LABS]2Current NDC, 1 package rows20250115_f6f7d369-64ef-0ed9-e053-6294a90a40fa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58264-0120-15826401200129.57 mL in 1 BOTTLE, GLASS (58264-0120-1) 29.57 ml2023-03-15NoNoHistorical