FDA.reportPublic FDA data

UNDA 270

Product NDC
62106-1166
11-digit product format
621061166
Labeler code
62106
Product ID
62106-1166_c733a765-4fc8-33c0-e053-2995a90a499e
Type
HUMAN OTC DRUG
Nonproprietary name
Calendula officinalis, Dulcamara, Equisetum arvense, Hypericum perforatum
Dosage form
LIQUID
Route
ORAL
Labeler
Seroyal USA
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-10-17
Substance
CALENDULA OFFICINALIS FLOWERING TOP; EQUISETUM ARVENSE BRANCH; HYPERICUM PERFORATUM; SOLANUM DULCAMARA STEM
Active strength
4; 4; 4; 4 [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 270
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOLANUM DULCAMARA STEM4 [hp_X]/20mL
CALENDULA OFFICINALIS FLOWERING TOP4 [hp_X]/20mL
EQUISETUM ARVENSE BRANCH4 [hp_X]/20mL
HYPERICUM PERFORATUM4 [hp_X]/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIR986LE7DF, 18E7415PXQ, 1L0VKZ185E, XK4IUX8MNB

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62106-1166-8UNDA 27020 mL in 1 BOTTLE, GLASSLIQUID203
62106-1166-8UNDA 2701 in 1 CARTONLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62106-1166UNDA 270 (CALENDULA OFFICINALIS, DULCAMARA, EQUISETUM ARVENSE, HYPERICUM PERFORATUM) LIQUID [SEROYAL USA]3Current NDC, Legacy NDC, 2 package rows20210717_5bb0acb9-be37-7096-e053-2a91aa0adf1c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62106-1166-8621061166081 BOTTLE, GLASS in 1 CARTON (62106-1166-8) / 20 mL in 1 BOTTLE, GLASS2017-10-170000-00-00NoNoCurrent