FDA.reportPublic FDA data

Voltaren

Product NDC
0067-8152
11-digit product format
000678152
Labeler code
0067
Product ID
0067-8152_71ee74f6-1c1d-4ba8-95be-9b9aefc02d3c
Type
HUMAN OTC DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Haleon US Holdings LLC
Application
NDA022122
Marketing category
NDA
Marketing start
2020-05-13
Substance
DICLOFENAC SODIUM
Active strength
10 mg/g
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Voltaren
Brand name suffix
Arthritis Pain
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855633, 855635

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-8152-01VoltarenArthritis Pain1 in 1 CARTONGEL113
0067-8152-01VoltarenArthritis Pain20 g in 1 TUBEGEL1 g10 mg in 1g13
0067-8152-01VoltarenArthritis Pain1 in 1 CARTONGEL10 mg in 1g13
0067-8152-01VoltarenArthritis Pain20 g in 1 TUBEGEL2013
0067-8152-02VoltarenArthritis Pain50 g in 1 TUBEGEL5013
0067-8152-02VoltarenArthritis Pain1 in 1 CARTONGEL113
0067-8152-03VoltarenArthritis Pain100 g in 1 TUBEGEL10013
0067-8152-03VoltarenArthritis Pain1 in 1 CARTONGEL113
0067-8152-03VoltarenArthritis Pain100 g in 1 TUBEGEL1 g10 mg in 1g13
0067-8152-03VoltarenArthritis Pain1 in 1 CARTONGEL10 mg in 1g13
0067-8152-04VoltarenArthritis Pain150 g in 1 TUBEGEL15013
0067-8152-04VoltarenArthritis Pain1 in 1 CARTONGEL113
0067-8152-05VoltarenArthritis Pain150 g in 1 TUBEGEL15013
0067-8152-05VoltarenArthritis Pain3 in 1 CARTONGEL313
0067-8152-08VoltarenArthritis Pain100 g in 1 TUBEGEL10013
0067-8152-08VoltarenArthritis Pain2 in 1 CARTONGEL213
0067-8152-09VoltarenArthritis Pain20 g in 1 TUBEGEL2013
0067-8152-09VoltarenArthritis Pain1 in 1 CARTONGEL113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-8152VOLTAREN ARTHRITIS PAIN (DICLOFENAC SODIUM) GEL VOLTAREN ARTHRITIS PAIN (DICLOFENAC SODIUM) KIT [HALEON US HOLDINGS LLC]13Current NDC, Legacy NDC, 14 package rows20250221_30a94282-0892-442a-aa10-6525cbd4fe88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSN30a94282-0892-442a-aa10-6525cbd4fe8813
855635Voltaren 1 % Topical GelPSN30a94282-0892-442a-aa10-6525cbd4fe8813
855635diclofenac sodium 0.01 MG/MG Topical Gel [Voltaren]SBD30a94282-0892-442a-aa10-6525cbd4fe8813
855633diclofenac sodium 0.01 MG/MG Topical GelSCD30a94282-0892-442a-aa10-6525cbd4fe8813
855633diclofenac sodium 1 % Topical GelSY30a94282-0892-442a-aa10-6525cbd4fe8813
855635Voltaren 0.01 MG/MG Topical GelSY30a94282-0892-442a-aa10-6525cbd4fe8813
855635Voltaren 1 % Topical GelSY30a94282-0892-442a-aa10-6525cbd4fe8813
855633diclofenac sodium 1 % Topical GelPSNde6519b6-1165-4ee3-aad0-97439a3768bb2
855635Voltaren 1 % Topical GelPSNde6519b6-1165-4ee3-aad0-97439a3768bb2
855635diclofenac sodium 0.01 MG/MG Topical Gel [Voltaren]SBDde6519b6-1165-4ee3-aad0-97439a3768bb2
855633diclofenac sodium 0.01 MG/MG Topical GelSCDde6519b6-1165-4ee3-aad0-97439a3768bb2
855633diclofenac sodium 1 % Topical GelSYde6519b6-1165-4ee3-aad0-97439a3768bb2
855635Voltaren 0.01 MG/MG Topical GelSYde6519b6-1165-4ee3-aad0-97439a3768bb2
855635Voltaren 1 % Topical GelSYde6519b6-1165-4ee3-aad0-97439a3768bb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0067-8152-01000678152011 TUBE in 1 CARTON (0067-8152-01) / 20 g in 1 TUBE1 tube2020-05-130000-00-00NoNoCurrent
0067-8152-02000678152021 TUBE in 1 CARTON (0067-8152-02) / 50 g in 1 TUBE1 tube2020-05-130000-00-00NoNoCurrent
0067-8152-03000678152031 TUBE in 1 CARTON (0067-8152-03) / 100 g in 1 TUBE1 tube2020-05-130000-00-00NoNoCurrent
0067-8152-04000678152041 TUBE in 1 CARTON (0067-8152-04) / 150 g in 1 TUBE1 tube2020-05-130000-00-00NoNoCurrent
0067-8152-0500067815205150 g in 1 TUBE150 gHistorical
0067-8152-08000678152082 TUBE in 1 CARTON (0067-8152-08) / 100 g in 1 TUBE2 tube2021-05-310000-00-00NoNoCurrent
0067-8152-09000678152091 TUBE in 1 CARTON (0067-8152-09) / 20 g in 1 TUBE1 tube2021-05-31NoNoCurrent