UPELVA

Product NDC
59469-319
11-digit product format
594690319
Labeler code
59469
Product ID
59469-319_25975778-438f-499f-9f7d-ee6697c6a18f
Type
HUMAN OTC DRUG
Nonproprietary name
CYCLAMEN PURPURASCENS TUBER, Chamaelirium luteum Root, HYPERICUM PERFORATUM, Potassium carbonate, Delphinium staphisagria Seed, Datura stramonium Flowering Top, Viburnum opulus Bark, and ZANTHOXYLUM AMERICANUM BARK
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
PEKANA Naturheilmittel GmbH
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-06-24
Substance
CHAMAELIRIUM LUTEUM ROOT; CYCLAMEN PURPURASCENS TUBER; DATURA STRAMONIUM FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; HYPERICUM PERFORATUM WHOLE; POTASSIUM CARBONATE; VIBURNUM OPULUS BARK; ZANTHOXYLUM AMERICANUM BARK
Active strength
4; 3; 10; 6; 3; 4; 1; 3 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHAMAELIRIUM LUTEUM ROOT4 [hp_X]/50mL
CYCLAMEN PURPURASCENS TUBER3 [hp_X]/50mL
DATURA STRAMONIUM FLOWERING TOP10 [hp_X]/50mL
DELPHINIUM STAPHISAGRIA SEED6 [hp_X]/50mL
HYPERICUM PERFORATUM WHOLE3 [hp_X]/50mL
POTASSIUM CARBONATE4 [hp_X]/50mL
VIBURNUM OPULUS BARK1 [hp_X]/50mL
ZANTHOXYLUM AMERICANUM BARK3 [hp_X]/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDQV54Y5H3U, G728143D8Q, ESJ6ZIS34B, 00543AP1JV, XK4IUX8MNB, BQN1B9B9HA, T1UG6H6805, A4KL1HMZ7T

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-319-10UPELVA50 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS502
59469-319-10UPELVA1 in 1 BOXSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-319UPELVA (CYCLAMEN PURPURASCENS TUBER, CHAMAELIRIUM LUTEUM ROOT, HYPERICUM PERFORATUM, POTASSIUM CARBONATE, DELPHINIUM STAPHISAGRIA SEED, DATURA STRAMONIUM FLOWERING TOP, VIBURNUM OPULUS BARK, AND ZANTHOXYLUM AMERICANUM BARK) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL GMBH]2Current NDC, Legacy NDC, 2 package rows20230113_0eb375d3-a0bb-4592-a2eb-6553f024d78c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59469-319-10594690319101 BOTTLE, GLASS in 1 BOX (59469-319-10) / 50 mL in 1 BOTTLE, GLASS2019-06-240000-00-00NoNoCurrent