FDA.reportPublic FDA data

KLIFEM

Product NDC
59469-311
Requested package NDC
59469-311-10
11-digit product format
594690311
Labeler code
59469
Product ID
59469-311_ffbcdaef-9ad8-4a94-8ee2-ced689a31acb
Type
HUMAN OTC DRUG
Nonproprietary name
aletris farinosa root, graphite, chamaelirium luteum root, pilocarpus jaborandii leaf, lachesis muta venom, anemone pratensis flowering top, sanguinaria canadensis root, and lamium album flowering top
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
PEKANA Naturheilmittel GmbH
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-06-24
Substance
ALETRIS FARINOSA ROOT; CHAMAELIRIUM LUTEUM ROOT; GRAPHITE; LACHESIS MUTA VENOM; LAMIUM ALBUM FLOWERING TOP; PILOCARPUS JABORANDII LEAF; PULSATILLA PRATENSIS FLOWERING TOP; SANGUINARIA CANADENSIS ROOT
Active strength
4; 3; 8; 8; 1475; 3; 3; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/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
KLIFEM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALETRIS FARINOSA ROOT4 [hp_X]/50mL
GRAPHITE3 [hp_X]/50mL
CHAMAELIRIUM LUTEUM ROOT8 [hp_X]/50mL
PILOCARPUS JABORANDII LEAF8 [hp_X]/50mL
LACHESIS MUTA VENOM1475 mg/50mL
PULSATILLA PRATENSIS FLOWERING TOP3 [hp_X]/50mL
SANGUINARIA CANADENSIS ROOT3 [hp_X]/50mL
LAMIUM ALBUM FLOWERING TOP6 [hp_X]/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O021JGR97XInternal UNII lookup
4QQN74LH4OInternal UNII lookup
DQV54Y5H3UInternal UNII lookup
26ZE1BZ2USInternal UNII lookup
VSW71SS07IInternal UNII lookup
29NVY5MR1AInternal UNII lookup
N9288CD508Internal UNII lookup
T95771X2XIInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6193b54f-cb07-43da-a18e-18c123e9179bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-311-10KLIFEM1 in 1 BOXSOLUTION/ DROPS12
59469-311-10KLIFEM50 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-311KLIFEM (ALETRIS FARINOSA ROOT, GRAPHITE, CHAMAELIRIUM LUTEUM ROOT, PILOCARPUS JABORANDII LEAF, LACHESIS MUTA VENOM, ANEMONE PRATENSIS FLOWERING TOP, SANGUINARIA CANADENSIS ROOT, AND LAMIUM ALBUM FLOWERING TOP) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL GMBH]2Current NDC, Legacy NDC, 2 package rows20230113_6193b54f-cb07-43da-a18e-18c123e9179b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KLIFEMALETRIS FARINOSA ROOT, GRAPHITE, CHAMAELIRIUM LUTEUM ROOT, PILOCARPUS JABORANDII LEAF, LACHESIS MUTA VENOM, ANEMONE PRATENSIS FLOWERING TOP, SANGUINARIA CANADENSIS ROOT, AND LAMIUM ALBUM FLOWERING TOPPEKANA Naturheilmittel GmbH6193b54f-cb07-43da-a18e-18c123e9179b2023-01-11WarningsExact identifier
ndc (package): 59469-311-10
ndc (product): 59469-311
ndc11 (package): 59469031110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59469-311-10594690311101 BOTTLE, GLASS in 1 BOX (59469-311-10) / 50 mL in 1 BOTTLE, GLASS2019-06-240000-00-00NoNoCurrent