NDC 58670-000 - Antidiarrheal LOPERAMIDE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 58670-000
Package NDCs from labels: 58670-000-10
Manufacturer: Holliday-Scott S.A. | Vasudha Pharma Chem Limited
Effective date: 2013-07-31
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Antidiarrheal LOPERAMIDE - Holliday-Scott S.A. \| Vasudha Pharma Chem Limited	Holliday-Scott S.A. \| Vasudha Pharma Chem Limited	2013-07-31	OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58670-000-10	Antidiarrheal LOPERAMIDE	1 in 1 CARTON	SOLUTION	1		1
58670-000-10	Antidiarrheal LOPERAMIDE	10 mL in 1 BOTTLE, DROPPER	SOLUTION	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58670-000	ANTIDIARRHEAL LOPERAMIDE (LOPERAMIDE HYDROCHLORIDE) SOLUTION [HOLLIDAY-SCOTT S.A.]	1	2 package rows	20130731_273e6635-c3e6-4739-9fd0-d227c789c367.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	ANTIDIARRHEAL LOPERAMIDE (LOPERAMIDE HYDROCHLORIDE) SOLUTION [HOLLIDAY-SCOTT S.A.]	1
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	ANTIDIARRHEAL LOPERAMIDE (LOPERAMIDE HYDROCHLORIDE) SOLUTION [HOLLIDAY-SCOTT S.A.]	1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 12 of 12 · 225 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Sense anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Proficient Rx LP	345be8d9-4fc9-40a2-a9f3-775d48beb85b	2019-10-01	Warnings	Exact identifier unii: 77TI35393C
Anti-Diarrheal	LOPERAMIDE HCL	First Aid Direct	952fa976-ac4c-4dfb-b689-12c5242498ac	2019-09-19	Warnings	Exact identifier unii: 77TI35393C
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	Bionpharma Inc.	8f1ee652-a4f7-4e5b-874f-46aa641cd43f	2019-09-09	Warnings	Exact identifier unii: 77TI35393C
Anti-Diarrheal	LOPERAMIDE HCL	Allegiant Health	aca3742c-2a82-4e91-8aaf-2fce08487e56	2017-11-13	Warnings	Exact identifier unii: 77TI35393C
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	8bf47ac3-746f-47c3-82b2-32ac979ff963	2016-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 77TI35393C

Reported adverse events (FAERS/openFDA)#

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