FDA.reportPublic FDA data

Bismuth Stibium

Product NDC
48951-2160
11-digit product format
489512160
Labeler code
48951
Product ID
48951-2160_34052c46-5d92-79f0-e063-6394a90a56da
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth Stibium
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Uriel Pharmacy Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2009-09-01
Substance
ANTIMONY; BISMUTH; CHELIDONIUM MAJUS; GARLIC; GRAPHITE; THUJA OCCIDENTALIS WHOLE; TURMERIC
Active strength
2; 2; 1; 1; 2; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANTIMONY2 [hp_X]/g
BISMUTH2 [hp_X]/g
CHELIDONIUM MAJUS1 [hp_X]/g
GARLIC1 [hp_X]/g
GRAPHITE2 [hp_X]/g
THUJA OCCIDENTALIS WHOLE1 [hp_X]/g
TURMERIC1 [hp_X]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9IT35J3UV3, U015TT5I8H, 7E889U5RNN, V1V998DC17, 4QQN74LH4O, 5HBV6WCE3N, 856YO1Z64F

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-2160-5Bismuth Stibium60 g in 1 TUBEOINTMENT607

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANTIMONYACTIVE INGREDIENT9IT35J3UV3BISMUTH STIBIUM WART RELIEF OINTMENT [URIEL PHARMACY INC.]1
BISMUTHACTIVE INGREDIENTU015TT5I8HBISMUTH STIBIUM WART RELIEF OINTMENT [URIEL PHARMACY INC.]1
CHELIDONIUM MAJUSACTIVE INGREDIENT7E889U5RNNBISMUTH STIBIUM WART RELIEF OINTMENT [URIEL PHARMACY INC.]1
GARLICACTIVE INGREDIENTV1V998DC17BISMUTH STIBIUM WART RELIEF OINTMENT [URIEL PHARMACY INC.]1
THUJA OCCIDENTALIS WHOLEACTIVE INGREDIENT5HBV6WCE3NBISMUTH STIBIUM WART RELIEF OINTMENT [URIEL PHARMACY INC.]1
TURMERICACTIVE INGREDIENT856YO1Z64FBISMUTH STIBIUM WART RELIEF OINTMENT [URIEL PHARMACY INC.]1
ANTIMONYACTIVE MOIETY9IT35J3UV3BISMUTH STIBIUM WART RELIEF OINTMENT [URIEL PHARMACY INC.]1
BISMUTHACTIVE MOIETYU015TT5I8HBISMUTH STIBIUM WART RELIEF OINTMENT [URIEL PHARMACY INC.]1
CHELIDONIUM MAJUSACTIVE MOIETY7E889U5RNNBISMUTH STIBIUM WART RELIEF OINTMENT [URIEL PHARMACY INC.]1
GARLICACTIVE MOIETYV1V998DC17BISMUTH STIBIUM WART RELIEF OINTMENT [URIEL PHARMACY INC.]1
THUJA OCCIDENTALIS WHOLEACTIVE MOIETY5HBV6WCE3NBISMUTH STIBIUM WART RELIEF OINTMENT [URIEL PHARMACY INC.]1
TURMERICACTIVE MOIETY856YO1Z64FBISMUTH STIBIUM WART RELIEF OINTMENT [URIEL PHARMACY INC.]1
CITRUS PARADISI SEEDINACTIVE INGREDIENT12F08874Y7BISMUTH STIBIUM WART RELIEF OINTMENT [URIEL PHARMACY INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4BISMUTH STIBIUM WART RELIEF OINTMENT [URIEL PHARMACY INC.]1
LANOLININACTIVE INGREDIENT7EV65EAW6HBISMUTH STIBIUM WART RELIEF OINTMENT [URIEL PHARMACY INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPBISMUTH STIBIUM WART RELIEF OINTMENT [URIEL PHARMACY INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBISMUTH STIBIUM WART RELIEF OINTMENT [URIEL PHARMACY INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4BISMUTH STIBIUM WART RELIEF OINTMENT [URIEL PHARMACY INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-2160BISMUTH STIBIUM OINTMENT [URIEL PHARMACY INC.]7Current NDC, 1 package rows20250502_2cb49bd7-529e-404e-a11f-10af464d7174.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48951-2160-54895121600560 g in 1 TUBE (48951-2160-5) 60 g2009-09-01NoNoCurrent