NDC 54868-6171 - GELNIQUE

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: 54868-6171
Package NDCs from labels: 54868-6171-0
Manufacturer: Physicians Total Care, Inc.
Effective date: 2009-01-15
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
GELNIQUE - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2009-01-15	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54868-6171-0	2019-09-24	C162847	48780-1	9350213a-41a5-c013-e053-90daa90a1393	These highlights do not include all the information needed to use GELNIQUE safely and effectively. See full prescribing information for GELNIQUE. GELNIQUE (oxybutynin chloride) gel for topical use Initial U.S. Approval: 1975

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54868-6171-0	GELNIQUE	1 g in 1 PACKET	GEL	1		1
54868-6171-0	GELNIQUE	30 in 1 CARTON	GEL	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54868-6171	GELNIQUE (OXYBUTYNIN CHLORIDE) GEL [PHYSICIANS TOTAL CARE, INC.]	1	2 package rows	20101001_a2a2ca0b-a685-4a60-b9c9-ffc3b6666c97.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54868-6171-0	GM - Gram	54868-6171	26bd73dc-7871-4bf7-ac5c-f426b6b7a227	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
OXYBUTYNIN CHLORIDE	ACTIVE INGREDIENT	L9F3D9RENQ	GELNIQUE (OXYBUTYNIN CHLORIDE) GEL [PHYSICIANS TOTAL CARE, INC.]	1
OXYBUTYNIN	ACTIVE MOIETY	K9P6MC7092	GELNIQUE (OXYBUTYNIN CHLORIDE) GEL [PHYSICIANS TOTAL CARE, INC.]	1