FDA.reportPublic FDA data

Balsamicum

Product NDC
48951-2159
11-digit product format
489512159
Labeler code
48951
Product ID
48951-2159_2b6073f5-2390-eff8-e063-6294a90a581a
Type
HUMAN OTC DRUG
Nonproprietary name
Balsamicum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Uriel Pharmacy, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2009-09-01
Substance
ANTIMONY; BALSAM PERU; CALENDULA OFFICINALIS FLOWERING TOP; LARIX DECIDUA RESIN; MERCURIALIS PERENNIS
Active strength
1; 1; 1; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANTIMONY1 [hp_X]/g
BALSAM PERU1 [hp_X]/g
CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]/g
LARIX DECIDUA RESIN1 [hp_X]/g
MERCURIALIS PERENNIS1 [hp_X]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9IT35J3UV3, 8P5F881OCY, 18E7415PXQ, AD8LJ73GQF, Q35465A1MA

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-2159-2Balsamicum30 g in 1 TUBEOINTMENT301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-2159BALSAMICUM OINTMENT [URIEL PHARMACY, INC]1Current NDC, 1 package rows20250112_2b6073f5-238f-eff8-e063-6294a90a581a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48951-2159-24895121590230 g in 1 TUBE (48951-2159-2) 30 g2009-09-01NoNoHistorical