FDA.reportPublic FDA data

AURUM STIBIUM HYOSCYAMUS

Product NDC
48951-1206
11-digit product format
489511206
Labeler code
48951
Product ID
48951-1206_6a346e13-ada3-be3a-e053-2991aa0abba6
Type
HUMAN OTC DRUG
Nonproprietary name
AURUM STIBIUM HYOSCYAMUS
Dosage form
LIQUID
Route
ORAL
Labeler
URIEL PHARMACY INC.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2009-09-01
Marketing end
0000-00-00
Substance
ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF; ANTIMONY; GOLD
Active strength
3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct48951-1206DDiscontinued by firm2026-10-05
excluded packagepackage48951-120648951-1206-3DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct48951-1206DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage48951-120648951-1206-3DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANTIMONYACTIVE INGREDIENT9IT35J3UV3AURUM STIBIUM HYOSCYAMUS LIQUID [URIEL PHARMACY INC.]1
GOLDACTIVE INGREDIENT79Y1949PYOAURUM STIBIUM HYOSCYAMUS LIQUID [URIEL PHARMACY INC.]1
HYOSCYAMUS NIGER LEAFACTIVE INGREDIENT32IT7G8BAWAURUM STIBIUM HYOSCYAMUS LIQUID [URIEL PHARMACY INC.]1
ONOPORDUM ACANTHIUM FLOWERACTIVE INGREDIENTAP97AUF88EAURUM STIBIUM HYOSCYAMUS LIQUID [URIEL PHARMACY INC.]1
PRIMULA VERIS FLOWERACTIVE INGREDIENTW5BET37294AURUM STIBIUM HYOSCYAMUS LIQUID [URIEL PHARMACY INC.]1
ANTIMONYACTIVE MOIETY9IT35J3UV3AURUM STIBIUM HYOSCYAMUS LIQUID [URIEL PHARMACY INC.]1
GOLDACTIVE MOIETY79Y1949PYOAURUM STIBIUM HYOSCYAMUS LIQUID [URIEL PHARMACY INC.]1
HYOSCYAMUS NIGER LEAFACTIVE MOIETY32IT7G8BAWAURUM STIBIUM HYOSCYAMUS LIQUID [URIEL PHARMACY INC.]1
ONOPORDUM ACANTHIUM FLOWERACTIVE MOIETYAP97AUF88EAURUM STIBIUM HYOSCYAMUS LIQUID [URIEL PHARMACY INC.]1
PRIMULA VERIS FLOWERACTIVE MOIETYW5BET37294AURUM STIBIUM HYOSCYAMUS LIQUID [URIEL PHARMACY INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554AURUM STIBIUM HYOSCYAMUS LIQUID [URIEL PHARMACY INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RAURUM STIBIUM HYOSCYAMUS LIQUID [URIEL PHARMACY INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-1206AURUM STIBIUM HYOSCYAMUS LIQUID [URIEL PHARMACY INC.]7Legacy NDC20241215_29ca80e6-3797-4ca2-a9cc-ea384b38ba5b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48951-1206-34895112060360 LIQUID in 1 BOTTLE, DROPPER (48951-1206-3) 60 liquid2009-09-010000-00-00NoNoCurrent