FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
58602-604
11-digit product format
586020604
Labeler code
58602
Product ID
58602-604_aa7e21b9-c07f-48a6-9266-67a490fd2b8b
Type
HUMAN OTC DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Aurohealth LLC
Application
ANDA204306
Marketing category
ANDA
Marketing start
2023-05-10
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
Diclofenac Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855633

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
58602-604-07Diclofenac Sodium1 in 1 CARTONGEL13
58602-604-07Diclofenac Sodium100 g in 1 TUBEGEL1003
58602-604-18Diclofenac Sodium20 g in 1 TUBEGEL203
58602-604-18Diclofenac Sodium1 in 1 CARTONGEL13
58602-604-19Diclofenac Sodium50 g in 1 TUBEGEL503
58602-604-19Diclofenac Sodium1 in 1 CARTONGEL13
58602-604-20Diclofenac Sodium1 in 1 CARTONGEL13
58602-604-20Diclofenac Sodium150 g in 1 TUBEGEL1503
58602-604-22Diclofenac Sodium150 g in 1 TUBEGEL1503
58602-604-22Diclofenac Sodium3 in 1 CARTONGEL33
58602-604-23Diclofenac Sodium2 in 1 CARTONGEL23
58602-604-23Diclofenac Sodium100 g in 1 TUBEGEL1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-604DICLOFENAC SODIUM GEL DICLOFENAC SODIUM KIT [AUROHEALTH LLC]3Current NDC, 12 package rows20240726_81e964ff-6622-4054-bf01-6ed6eef6778f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSN37362eb4-db16-f4ad-e063-6394a90a42aa3
855633diclofenac sodium 1 % Topical GelPSN81e964ff-6622-4054-bf01-6ed6eef6778f3
855633diclofenac sodium 0.01 MG/MG Topical GelSCD37362eb4-db16-f4ad-e063-6394a90a42aa3
855633diclofenac sodium 0.01 MG/MG Topical GelSCD81e964ff-6622-4054-bf01-6ed6eef6778f3
855633diclofenac sodium 1 % Topical GelSY37362eb4-db16-f4ad-e063-6394a90a42aa3
855633diclofenac sodium 1 % Topical GelSY81e964ff-6622-4054-bf01-6ed6eef6778f3
855633diclofenac sodium 1 % Topical GelPSN929f71ab-f0c8-4331-800d-ed4a172e647e1
855633diclofenac sodium 0.01 MG/MG Topical GelSCD929f71ab-f0c8-4331-800d-ed4a172e647e1
855633diclofenac sodium 1 % Topical GelSY929f71ab-f0c8-4331-800d-ed4a172e647e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-604-07586020604071 TUBE in 1 CARTON (58602-604-07) / 100 g in 1 TUBE1 tube2023-05-10NoNoCurrent
58602-604-18586020604181 TUBE in 1 CARTON (58602-604-18) / 20 g in 1 TUBE1 tube2023-05-10NoNoCurrent
58602-604-19586020604191 TUBE in 1 CARTON (58602-604-19) / 50 g in 1 TUBE1 tube2023-05-10NoNoCurrent
58602-604-20586020604201 TUBE in 1 CARTON (58602-604-20) / 150 g in 1 TUBE1 tube2023-05-10NoNoCurrent
58602-604-22586020604223 TUBE in 1 CARTON (58602-604-22) / 150 g in 1 TUBE3 tube2023-05-10NoNoCurrent
58602-604-23586020604232 TUBE in 1 CARTON (58602-604-23) / 100 g in 1 TUBE2 tube2023-05-10NoNoCurrent