RENELIX

Product NDC
59469-315
11-digit product format
594690315
Labeler code
59469
Product ID
59469-315_8ddbd870-0a08-4be8-8d59-b56c164cd02f
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoic Acid, Nitric Acid, Apis mellifera, Berberis Vulgaris Root Bark, Colchicum autumnale Bulb, Protortonia Cacti, Solidago virgaurea Flowering Top, and Capsella bursa-pastoris Top
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
PEKANA Naturheilmittel GmbH
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-06-24
Substance
APIS MELLIFERA; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; CAPSELLA BURSA-PASTORIS TOP; COLCHICUM AUTUMNALE BULB; NITRIC ACID; PROTORTONIA CACTI; SOLIDAGO VIRGAUREA FLOWERING TOP
Active strength
4; 4; 3; 510; 12; 6; 631; 2913 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL; mg/50mL
Pharmacologic classes
Allergens [CS], Ammonium Ion Binding Activity [MoA], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrogen Binding Agent [EPC], Standardized Insect Venom Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APIS MELLIFERA4 [hp_X]/50mL
BENZOIC ACID4 [hp_X]/50mL
BERBERIS VULGARIS ROOT BARK3 [hp_X]/50mL
CAPSELLA BURSA-PASTORIS TOP510 mg/50mL
COLCHICUM AUTUMNALE BULB12 [hp_X]/50mL
NITRIC ACID6 [hp_X]/50mL
PROTORTONIA CACTI631 mg/50mL
SOLIDAGO VIRGAUREA FLOWERING TOP2913 mg/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S82P3R43Z, 8SKN0B0MIM, 1TH8Q20J0U, 7D8DU3293G, 993QHL78E6, 411VRN1TV4, LZB7TFX1LT, 5405K23S50

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-315-10RENELIX1 in 1 BOXSOLUTION/ DROPS12
59469-315-10RENELIX50 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS502
59469-315-40RENELIX1 in 1 BOXSOLUTION/ DROPS12
59469-315-40RENELIX100 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-315RENELIX (BENZOIC ACID, NITRIC ACID, APIS MELLIFERA, BERBERIS VULGARIS ROOT BARK, COLCHICUM AUTUMNALE BULB, PROTORTONIA CACTI, SOLIDAGO VIRGAUREA FLOWERING TOP, AND CAPSELLA BURSA-PASTORIS TOP) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL GMBH]2Current NDC, Legacy NDC, 4 package rows20230113_11a057e9-4b2a-4de0-a7e9-fbd4029bb7a8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59469-315-10594690315101 BOTTLE, GLASS in 1 BOX (59469-315-10) / 50 mL in 1 BOTTLE, GLASS2019-06-240000-00-00NoNoCurrent
59469-315-40594690315401 BOTTLE, GLASS in 1 BOX (59469-315-40) / 100 mL in 1 BOTTLE, GLASS2019-06-240000-00-00NoNoCurrent