ITIRES

Product NDC
59469-309
11-digit product format
594690309
Labeler code
59469
Product ID
59469-309_d5273f5c-c438-4f63-b7a6-fc209c1ff1c4
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica montana Root, CALCIUM FLUORIDE, CALCIUM IODIDE, Clematis recta Flowering Top, Scrophularia nodosa, Conium maculatum Flowering Top, HORSE CHESTNUT, and Hedera helix Flowering Twig
Dosage form
OINTMENT
Route
CUTANEOUS
Labeler
PEKANA Naturheilmittel GmbH
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-06-24
Substance
ARNICA MONTANA ROOT; CALCIUM FLUORIDE; CALCIUM IODIDE; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; HORSE CHESTNUT; SCROPHULARIA NODOSA WHOLE
Active strength
8; 8; 6; 4; 6; 6; 4; 2 [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA ROOT8 [hp_X]/35g
CALCIUM FLUORIDE8 [hp_X]/35g
CALCIUM IODIDE6 [hp_X]/35g
CLEMATIS RECTA FLOWERING TOP4 [hp_X]/35g
CONIUM MACULATUM FLOWERING TOP6 [hp_X]/35g
HEDERA HELIX FLOWERING TWIG6 [hp_X]/35g
HORSE CHESTNUT4 [hp_X]/35g
SCROPHULARIA NODOSA WHOLE2 [hp_X]/35g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMUE8Y11327, O3B55K4YKI, 8EKI9QEE2H, 396421SP9F, Q28R5GF371, 3D10KUA6BM, 3C18L6RJAZ, 7H443NUB2T

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-309-30ITIRES30 g in 1 TUBEOINTMENT303
59469-309-30ITIRES1 in 1 BOXOINTMENT13
59469-309-35ITIRES35 g in 1 TUBEOINTMENT353
59469-309-35ITIRES1 in 1 BOXOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-309ITIRES (ARNICA MONTANA ROOT, CALCIUM FLUORIDE, CALCIUM IODIDE, CLEMATIS RECTA FLOWERING TOP, SCROPHULARIA NODOSA, CONIUM MACULATUM FLOWERING TOP, HORSE CHESTNUT, AND HEDERA HELIX FLOWERING TWIG) OINTMENT [PEKANA NATURHEILMITTEL GMBH]3Current NDC, Legacy NDC, 4 package rows20221224_8d93bb65-8021-4ef2-87a8-ee90ebd7dc06.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59469-309-30594690309301 TUBE in 1 BOX (59469-309-30) / 30 g in 1 TUBE1 tube2019-06-240000-00-00NoNoCurrent
59469-309-35594690309351 TUBE in 1 BOX (59469-309-35) / 35 g in 1 TUBE1 tube2019-06-240000-00-00NoNoCurrent