Voltaren

Product NDC: 63481-684
11-digit product format: 634810684
Labeler code: 63481
Product ID: 63481-684_16e1d289-8ac0-4070-b29e-e3a286d724c1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diclofenac sodium
Dosage form: GEL
Route: TOPICAL
Labeler: Endo Pharmaceuticals Inc.
Application: NDA022122
Marketing category: NDA
Marketing start: 2007-10-17
Marketing end: 2022-04-30
Substance: DICLOFENAC SODIUM
Active strength: 10 mg/g
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
111d457e-3138-4512-b0ba-d0cd760c4055	Product name	3	20250225
0426261e-1bb9-b78b-abd2-80da765a7e3e	Product name	2	20240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7	Product name	5	20240320
0ac2f11f-f58d-baf2-71a0-680993b48a61	Product name	2	20231211
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
855d63c3-b090-4636-8fc7-6d39ad23c44f	Product name	1	20230829
bb58f410-04be-65dd-9211-e89ead899698	Product name	6	20230323
0fcbc38a-8b29-3348-1cef-5222ea53484f	Product name	4	20220516
c4e1eedc-aca2-4551-8382-89144ed9d049	Product name	3	20220126
8d368a34-1453-43ea-828d-0dbcd72b8794	Product name	8	20210622
d6bab9d2-edce-a213-4796-226ab15472c3	Product name	6	20200616
2487e6ef-d419-42fc-aaf8-7acc805d2370	Product name	2	20170718
e071c814-e5e7-e7ed-ec76-428765d9c66b	Product name	2	20151120
93148e06-b8d7-4e6c-853e-62f807d17fbb	Product name	1	20151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247e	Product name	1	20150316

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63481-684-03	GM - Gram	63481-684	ca0a849d-81d2-4bea-abab-fc8796645975	1	2012-07-24
63481-684-05	GM - Gram	63481-684	aa1648cb-43af-423b-b4f7-7e08d816569a	1	2012-07-24
63481-684-47	GM - Gram	63481-684	8dc46f8e-2419-4302-9dc3-2cf6d0611557	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	VOLTAREN (DICLOFENAC SODIUM) GEL [STAT RX USA LLC]	5
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	VOLTAREN (DICLOFENAC SODIUM) GEL [STAT RX USA LLC]	5
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	VOLTAREN (DICLOFENAC SODIUM) GEL [STAT RX USA LLC]	5
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	VOLTAREN (DICLOFENAC SODIUM) GEL [STAT RX USA LLC]	5
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	VOLTAREN (DICLOFENAC SODIUM) GEL [STAT RX USA LLC]	5
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	VOLTAREN (DICLOFENAC SODIUM) GEL [STAT RX USA LLC]	5
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	VOLTAREN (DICLOFENAC SODIUM) GEL [STAT RX USA LLC]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	VOLTAREN (DICLOFENAC SODIUM) GEL [STAT RX USA LLC]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	VOLTAREN (DICLOFENAC SODIUM) GEL [STAT RX USA LLC]	5
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	VOLTAREN GEL [DIRECT RX]	2
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	VOLTAREN (DICLOFENAC SODIUM) GEL [UNIT DOSE SERVICES]	2
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	VOLTAREN (DICLOFENAC SODIUM) GEL [UNIT DOSE SERVICES]	2
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	VOLTAREN GEL [DIRECT RX]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	VOLTAREN (DICLOFENAC SODIUM) GEL [UNIT DOSE SERVICES]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	VOLTAREN GEL [DIRECT RX]	2
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	VOLTAREN (DICLOFENAC SODIUM) GEL [UNIT DOSE SERVICES]	2
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	VOLTAREN GEL [DIRECT RX]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	VOLTAREN (DICLOFENAC SODIUM) GEL [UNIT DOSE SERVICES]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	VOLTAREN GEL [DIRECT RX]	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	VOLTAREN (DICLOFENAC SODIUM) GEL [UNIT DOSE SERVICES]	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	VOLTAREN GEL [DIRECT RX]	2
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	VOLTAREN (DICLOFENAC SODIUM) GEL [UNIT DOSE SERVICES]	2
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	VOLTAREN GEL [DIRECT RX]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	VOLTAREN GEL [DIRECT RX]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	VOLTAREN (DICLOFENAC SODIUM) GEL [UNIT DOSE SERVICES]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	VOLTAREN GEL [DIRECT RX]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	VOLTAREN (DICLOFENAC SODIUM) GEL [UNIT DOSE SERVICES]	2
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	VOLTAREN (DICLOFENAC SODIUM) GEL [KELTMAN PHARMACEUTICALS INC.]	1
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	VOLTAREN (DICLOFENAC SODIUM) GEL [STAT RX USA LLC]	1
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	VOLTAREN (DICLOFENAC SODIUM) GEL [PHYSICIANS TOTAL CARE, INC.]	1
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	VOLTAREN (DICLOFENAC SODIUM) GEL [REBEL DISTRIBUTORS CORP]	1
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	VOLTAREN (DICLOFENAC SODIUM) GEL [STAT RX USA LLC]	1
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	VOLTAREN (DICLOFENAC SODIUM) GEL [PHYSICIANS TOTAL CARE, INC.]	1
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	VOLTAREN (DICLOFENAC SODIUM) GEL [KELTMAN PHARMACEUTICALS INC.]	1
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	VOLTAREN (DICLOFENAC SODIUM) GEL [REBEL DISTRIBUTORS CORP]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	VOLTAREN (DICLOFENAC SODIUM) GEL [STAT RX USA LLC]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	VOLTAREN (DICLOFENAC SODIUM) GEL [PHYSICIANS TOTAL CARE, INC.]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	VOLTAREN (DICLOFENAC SODIUM) GEL [KELTMAN PHARMACEUTICALS INC.]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	VOLTAREN (DICLOFENAC SODIUM) GEL [REBEL DISTRIBUTORS CORP]	1
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	VOLTAREN (DICLOFENAC SODIUM) GEL [REBEL DISTRIBUTORS CORP]	1
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	VOLTAREN (DICLOFENAC SODIUM) GEL [KELTMAN PHARMACEUTICALS INC.]	1
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	VOLTAREN (DICLOFENAC SODIUM) GEL [STAT RX USA LLC]	1
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	VOLTAREN (DICLOFENAC SODIUM) GEL [PHYSICIANS TOTAL CARE, INC.]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	VOLTAREN (DICLOFENAC SODIUM) GEL [STAT RX USA LLC]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	VOLTAREN (DICLOFENAC SODIUM) GEL [KELTMAN PHARMACEUTICALS INC.]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	VOLTAREN (DICLOFENAC SODIUM) GEL [REBEL DISTRIBUTORS CORP]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	VOLTAREN (DICLOFENAC SODIUM) GEL [PHYSICIANS TOTAL CARE, INC.]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	VOLTAREN (DICLOFENAC SODIUM) GEL [PHYSICIANS TOTAL CARE, INC.]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	VOLTAREN (DICLOFENAC SODIUM) GEL [REBEL DISTRIBUTORS CORP]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	VOLTAREN (DICLOFENAC SODIUM) GEL [KELTMAN PHARMACEUTICALS INC.]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	VOLTAREN (DICLOFENAC SODIUM) GEL [STAT RX USA LLC]	1
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	VOLTAREN (DICLOFENAC SODIUM) GEL [PHYSICIANS TOTAL CARE, INC.]	1
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	VOLTAREN (DICLOFENAC SODIUM) GEL [STAT RX USA LLC]	1
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	VOLTAREN (DICLOFENAC SODIUM) GEL [KELTMAN PHARMACEUTICALS INC.]	1
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	VOLTAREN (DICLOFENAC SODIUM) GEL [REBEL DISTRIBUTORS CORP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	VOLTAREN (DICLOFENAC SODIUM) GEL [KELTMAN PHARMACEUTICALS INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	VOLTAREN (DICLOFENAC SODIUM) GEL [PHYSICIANS TOTAL CARE, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	VOLTAREN (DICLOFENAC SODIUM) GEL [STAT RX USA LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	VOLTAREN (DICLOFENAC SODIUM) GEL [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	VOLTAREN (DICLOFENAC SODIUM) GEL [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	VOLTAREN (DICLOFENAC SODIUM) GEL [KELTMAN PHARMACEUTICALS INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	VOLTAREN (DICLOFENAC SODIUM) GEL [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	VOLTAREN (DICLOFENAC SODIUM) GEL [STAT RX USA LLC]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QTG126297Q	DICLOFENAC SODIUM	15307-79-6	DICLOFENAC SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855633	diclofenac sodium 1 % Topical Gel	PSN	ea23fc47-3b7b-4fad-ae34-b6eb6913d957	5
855633	diclofenac sodium 1 % Topical Gel	PSN	e1685937-3980-40e3-8f04-998174fef3a2	5
855635	Voltaren 1 % Topical Gel	PSN	e1685937-3980-40e3-8f04-998174fef3a2	5
855635	Voltaren 1 % Topical Gel	PSN	ea23fc47-3b7b-4fad-ae34-b6eb6913d957	5
855635	diclofenac sodium 0.01 MG/MG Topical Gel [Voltaren]	SBD	e1685937-3980-40e3-8f04-998174fef3a2	5
855635	diclofenac sodium 0.01 MG/MG Topical Gel [Voltaren]	SBD	ea23fc47-3b7b-4fad-ae34-b6eb6913d957	5
855633	diclofenac sodium 0.01 MG/MG Topical Gel	SCD	ea23fc47-3b7b-4fad-ae34-b6eb6913d957	5
855633	diclofenac sodium 0.01 MG/MG Topical Gel	SCD	e1685937-3980-40e3-8f04-998174fef3a2	5
855633	diclofenac sodium 1 % Topical Gel	SY	ea23fc47-3b7b-4fad-ae34-b6eb6913d957	5
855633	diclofenac sodium 1 % Topical Gel	SY	e1685937-3980-40e3-8f04-998174fef3a2	5
855635	Voltaren 0.01 MG/MG Topical Gel	SY	ea23fc47-3b7b-4fad-ae34-b6eb6913d957	5
855635	Voltaren 0.01 MG/MG Topical Gel	SY	e1685937-3980-40e3-8f04-998174fef3a2	5
855635	Voltaren 1 % Topical Gel	SY	ea23fc47-3b7b-4fad-ae34-b6eb6913d957	5
855635	Voltaren 1 % Topical Gel	SY	e1685937-3980-40e3-8f04-998174fef3a2	5
855633	diclofenac sodium 1 % Topical Gel	PSN	b04009ca-7545-4cd4-af63-f15aebf20f18	2
855633	diclofenac sodium 0.01 MG/MG Topical Gel	SCD	b04009ca-7545-4cd4-af63-f15aebf20f18	2
855633	diclofenac sodium 1 % Topical Gel	SY	b04009ca-7545-4cd4-af63-f15aebf20f18	2
855633	diclofenac sodium 1 % Topical Gel	PSN	1940300f-2b4a-4016-a1bb-21f821797a89	1
855633	diclofenac sodium 1 % Topical Gel	PSN	26b2d99e-d471-4758-8aa0-a26ef464eb35	1
855633	diclofenac sodium 1 % Topical Gel	PSN	137c4e7a-e671-413e-b687-89490ef98974	1
855633	diclofenac sodium 1 % Topical Gel	PSN	4c9f995c-d687-483a-b6bb-11c8b263681b	1
855635	Voltaren 1 % Topical Gel	PSN	1940300f-2b4a-4016-a1bb-21f821797a89	1
855635	Voltaren 1 % Topical Gel	PSN	26b2d99e-d471-4758-8aa0-a26ef464eb35	1
855635	Voltaren 1 % Topical Gel	PSN	137c4e7a-e671-413e-b687-89490ef98974	1
855635	Voltaren 1 % Topical Gel	PSN	4c9f995c-d687-483a-b6bb-11c8b263681b	1
855635	diclofenac sodium 0.01 MG/MG Topical Gel [Voltaren]	SBD	4c9f995c-d687-483a-b6bb-11c8b263681b	1
855635	diclofenac sodium 0.01 MG/MG Topical Gel [Voltaren]	SBD	137c4e7a-e671-413e-b687-89490ef98974	1
855635	diclofenac sodium 0.01 MG/MG Topical Gel [Voltaren]	SBD	1940300f-2b4a-4016-a1bb-21f821797a89	1
855635	diclofenac sodium 0.01 MG/MG Topical Gel [Voltaren]	SBD	26b2d99e-d471-4758-8aa0-a26ef464eb35	1
855633	diclofenac sodium 0.01 MG/MG Topical Gel	SCD	137c4e7a-e671-413e-b687-89490ef98974	1
855633	diclofenac sodium 0.01 MG/MG Topical Gel	SCD	4c9f995c-d687-483a-b6bb-11c8b263681b	1
855633	diclofenac sodium 0.01 MG/MG Topical Gel	SCD	1940300f-2b4a-4016-a1bb-21f821797a89	1
855633	diclofenac sodium 0.01 MG/MG Topical Gel	SCD	26b2d99e-d471-4758-8aa0-a26ef464eb35	1
855633	diclofenac sodium 1 % Topical Gel	SY	26b2d99e-d471-4758-8aa0-a26ef464eb35	1
855633	diclofenac sodium 1 % Topical Gel	SY	1940300f-2b4a-4016-a1bb-21f821797a89	1
855633	diclofenac sodium 1 % Topical Gel	SY	137c4e7a-e671-413e-b687-89490ef98974	1
855633	diclofenac sodium 1 % Topical Gel	SY	4c9f995c-d687-483a-b6bb-11c8b263681b	1
855635	Voltaren 0.01 MG/MG Topical Gel	SY	26b2d99e-d471-4758-8aa0-a26ef464eb35	1
855635	Voltaren 0.01 MG/MG Topical Gel	SY	4c9f995c-d687-483a-b6bb-11c8b263681b	1
855635	Voltaren 0.01 MG/MG Topical Gel	SY	1940300f-2b4a-4016-a1bb-21f821797a89	1
855635	Voltaren 0.01 MG/MG Topical Gel	SY	137c4e7a-e671-413e-b687-89490ef98974	1
855635	Voltaren 1 % Topical Gel	SY	26b2d99e-d471-4758-8aa0-a26ef464eb35	1
855635	Voltaren 1 % Topical Gel	SY	1940300f-2b4a-4016-a1bb-21f821797a89	1
855635	Voltaren 1 % Topical Gel	SY	4c9f995c-d687-483a-b6bb-11c8b263681b	1
855635	Voltaren 1 % Topical Gel	SY	137c4e7a-e671-413e-b687-89490ef98974	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63481-684-47	63481068447	1 TUBE in 1 CARTON (63481-684-47) > 100 g in 1 TUBE	1 tube	2007-10-17	2022-04-30	No	No	Current
63481-684-83	63481068483	1 TUBE in 1 CARTON (63481-684-83) > 20 g in 1 TUBE	1 tube	2007-10-17	2022-04-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Voltaren	Unit Dose Services	2017-08-28	HUMAN PRESCRIPTION DRUG LABEL	5
VOLTAREN	DIRECT RX	2015-08-10	HUMAN PRESCRIPTION DRUG LABEL	2
VOLTAREN	STAT Rx USA LLC \| PSS World Medical Inc.	2012-02-23	HUMAN PRESCRIPTION DRUG LABEL	5
Voltaren	Physicians Total Care, Inc.	2012-01-09	HUMAN PRESCRIPTION DRUG LABEL	1
Voltaren	Keltman Pharmaceuticals Inc.	2011-06-06	HUMAN PRESCRIPTION DRUG LABEL	1
Voltaren	Rebel Distributors Corp	2010-12-01	HUMAN PRESCRIPTION DRUG LABEL	1
VOLTAREN	STAT RX USA LLC	2010-03-18	HUMAN PRESCRIPTION DRUG LABEL	1

Voltaren

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#