FDA.reportPublic FDA data

UNDA 243

Product NDC
62106-1196
11-digit product format
621061196
Labeler code
62106
Product ID
62106-1196_ed11f0cb-f2b2-732a-e053-2a95a90a6c45
Type
HUMAN OTC DRUG
Nonproprietary name
Boldo, Cholesterinum, Taraxacum officinale, Lycopodium clavatum, Podophyllum peltatum
Dosage form
LIQUID
Route
ORAL
Labeler
Seroyal USA
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-04-01
Substance
CHOLESTEROL; LYCOPODIUM CLAVATUM SPORE; PEUMUS BOLDUS LEAF; PODOPHYLLUM; TARAXACUM OFFICINALE
Active strength
12; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
UNDA 243
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHOLESTEROL12 [hp_X]/20mL
LYCOPODIUM CLAVATUM SPORE4 [hp_X]/20mL
PEUMUS BOLDUS LEAF4 [hp_X]/20mL
PODOPHYLLUM4 [hp_X]/20mL
TARAXACUM OFFICINALE4 [hp_X]/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii97C5T2UQ7J, C88X29Y479, Q4EWM09M3O, 2S713A4VP3, 39981FM375

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62106-1196-8UNDA 24320 mL in 1 BOTTLE, GLASSLIQUID203
62106-1196-8UNDA 2431 in 1 CARTONLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62106-1196UNDA 243 (BOLDO, CHOLESTERINUM, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM, PODOPHYLLUM PELTATUM) LIQUID [SEROYAL USA]3Current NDC, Legacy NDC, 2 package rows20221110_8ed674c3-a628-9715-e053-2a95a90aa099.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62106-1196-8621061196081 BOTTLE, GLASS in 1 CARTON (62106-1196-8) / 20 mL in 1 BOTTLE, GLASS2020-04-010000-00-00NoNoCurrent