FDA.reportPublic FDA data

HABIFAC

Product NDC
59469-141
11-digit product format
594690141
Labeler code
59469
Product ID
59469-141_2989c3c6-5187-4615-8c71-31912aa57a10
Type
HUMAN OTC DRUG
Nonproprietary name
Formic Acid, Nitric Acid, Baptisia tinctoria Root, Graphite, Calcium sulfide, Thuja occidentalis Leafy Twig, Cynanchum Vincetoxicum Leaf, and Glechoma hederacea Flowering Top
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
PEKANA Naturheilmittel GmbH
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2008-04-12
Substance
BAPTISIA TINCTORIA ROOT; CALCIUM SULFIDE; FORMIC ACID; GLECHOMA HEDERACEA FLOWERING TOP; GRAPHITE; NITRIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; VINCETOXICUM HIRUNDINARIA LEAF
Active strength
5; 8; 8; 4; 8; 6; 10; 8 [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
HABIFAC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FORMIC ACID5 [hp_X]/50mL
NITRIC ACID8 [hp_X]/50mL
BAPTISIA TINCTORIA ROOT8 [hp_X]/50mL
GRAPHITE4 [hp_X]/50mL
CALCIUM SULFIDE8 [hp_X]/50mL
THUJA OCCIDENTALIS LEAFY TWIG6 [hp_X]/50mL
VINCETOXICUM HIRUNDINARIA LEAF10 [hp_X]/50mL
GLECHOMA HEDERACEA FLOWERING TOP8 [hp_X]/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0YIW783RG1Internal UNII lookup
411VRN1TV4Internal UNII lookup
5EF0HWI5WUInternal UNII lookup
4QQN74LH4OInternal UNII lookup
1MBW07J51QInternal UNII lookup
1NT28V9397Internal UNII lookup
9WLP0FA6U4Internal UNII lookup
2458J91U39Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b5fd91ae-3822-421a-a449-4178111950bcAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-141-10HABIFAC1 in 1 BOXSOLUTION/ DROPS15
59469-141-10HABIFAC50 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-141HABIFAC (FORMIC ACID, NITRIC ACID, BAPTISIA TINCTORIA ROOT, GRAPHITE, CALCIUM SULFIDE, THUJA OCCIDENTALIS LEAFY TWIG, CYNANCHUM VINCETOXICUM LEAF, AND GLECHOMA HEDERACEA FLOWERING TOP) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL GMBH]5Current NDC, Legacy NDC, 2 package rows20221217_b5fd91ae-3822-421a-a449-4178111950bc.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
HABIFACFORMIC ACID, NITRIC ACID, BAPTISIA TINCTORIA ROOT, GRAPHITE, CALCIUM SULFIDE, THUJA OCCIDENTALIS LEAFY TWIG, CYNANCHUM VINCETOXICUM LEAF, AND GLECHOMA HEDERACEA FLOWERING TOPPEKANA Naturheilmittel GmbHb5fd91ae-3822-421a-a449-4178111950bc2022-12-15WarningsExact identifier
ndc (product): 59469-141

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59469-141-10594690141101 BOTTLE, GLASS in 1 BOX (59469-141-10) / 50 mL in 1 BOTTLE, GLASS2008-04-120000-00-00NoNoCurrent