Spigelia comp

Product NDC: 48951-8368
11-digit product format: 489518368
Labeler code: 48951
Product ID: 48951-8368_b699ea99-a012-2ecb-e053-2a95a90a6c29
Type: HUMAN OTC DRUG
Nonproprietary name: Spigelia comp
Dosage form: LIQUID
Route: ORAL
Labeler: Uriel Pharmacy Inc.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2009-09-01
Marketing end: 0000-00-00
Substance: ACONITUM NAPELLUS; SODIUM NITRITE; ARNICA MONTANA FLOWER; PHOSPHORUS; SPIGELIA MARILANDICA ROOT; SILVER NITRATE
Active strength: 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag: No
Listing certified through: 2021-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	48951-8368		I	Inactivated by FDA		2026-10-05
excluded package	package	48951-8368	48951-8368-1	I	Inactivated by FDA		2026-10-05

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

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4073022c-5d5d-48f5-82ed-091ad146a4b2	Product name	1	20171211
6cca4355-1206-91f7-02de-17eef38a8622	Product name	1	20140508
70dd82cf-c501-052d-5d98-d42ef9849750	Product name	1	20140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
48951-8368-1	Spigelia comp	1 mL in 1 AMPULE	LIQUID	1		1
48951-8368-1	Spigelia comp	10 in 1 BOX	LIQUID	10		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
48951-8368	SPIGELIA COMP LIQUID [URIEL PHARMACY INC.]	1	Legacy NDC, 2 package rows	20201218_b699ea99-a011-2ecb-e053-2a95a90a6c29.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U0NQ8555JD	ACONITUM NAPELLUS		ACONITUM NAPELLUS
M0KG633D4F	SODIUM NITRITE	7632-00-0	SODIUM NITRITE
OZ0E5Y15PZ	ARNICA MONTANA FLOWER		ARNICA MONTANA FLOWER
27YLU75U4W	PHOSPHORUS	7723-14-0	PHOSPHORUS
467D26HS0B	SPIGELIA MARILANDICA ROOT		SPIGELIA MARILANDICA ROOT
95IT3W8JZE	SILVER NITRATE	7761-88-8	SILVER NITRATE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
48951-8368-1	48951836801	10 AMPULE in 1 BOX (48951-8368-1) > 1 mL in 1 AMPULE	10 ampule	2009-09-01	0000-00-00	No	No	Current