FDA.reportPublic FDA data

good sense arthritis pain

Product NDC
0113-1189
11-digit product format
001131189
Labeler code
0113
Product ID
0113-1189_6e5aa684-f3be-4a0f-82d5-9259d6bb0d19
Type
HUMAN OTC DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
L. Perrigo Company
Application
ANDA211253
Marketing category
ANDA
Marketing start
2020-08-22
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
good sense 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

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
07b45089-afbe-518f-59f0-bf5b3c5b5d4eProduct name420210927
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
0113-1189-01Lefluniclo100 g in 1 TUBEGEL100 g10 mg in 1g8
0113-1189-01good sense arthritis pain1 in 1 CARTONGEL13
0113-1189-01good sense arthritis pain100 g in 1 TUBEGEL1003
0113-1189-03good sense arthritis pain150 g in 1 TUBEGEL1503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-1189-03GM - Gram0113-1189e3b67ab3-cd05-482a-9269-52994d20e87412021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-1189LEFLUNICLO (LEFLUNOMIDE AND DICLOFENAC SODIUM GEL) KIT [V2 PHARMA, LLC]8Current NDC, Legacy NDC20230331_91d62919-c4bb-4dd0-af23-c5183bc53d00.zip
0113-1189GOOD SENSE ARTHRITIS PAIN (DICLOFENAC SODIUM) GEL [L. PERRIGO COMPANY]3Current NDC, Legacy NDC, 3 package rows20230628_7b32b9e4-6502-4fa3-808f-3bef9525b6a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSN91d62919-c4bb-4dd0-af23-c5183bc53d008
205285leflunomide 20 MG Oral TabletPSN91d62919-c4bb-4dd0-af23-c5183bc53d008
855633diclofenac sodium 0.01 MG/MG Topical GelSCD91d62919-c4bb-4dd0-af23-c5183bc53d008
205285leflunomide 20 MG Oral TabletSCD91d62919-c4bb-4dd0-af23-c5183bc53d008
855633diclofenac sodium 1 % Topical GelSY91d62919-c4bb-4dd0-af23-c5183bc53d008
855633diclofenac sodium 1 % Topical GelPSN7b32b9e4-6502-4fa3-808f-3bef9525b6a13
855633diclofenac sodium 0.01 MG/MG Topical GelSCD7b32b9e4-6502-4fa3-808f-3bef9525b6a13
855633diclofenac sodium 1 % Topical GelSY7b32b9e4-6502-4fa3-808f-3bef9525b6a13
855633diclofenac sodium 1 % Topical GelPSN67eacd91-8378-47e7-9bad-1e7b685aa9d41
855633diclofenac sodium 1 % Topical GelPSN5f1ca9c1-c7fe-4a91-af5e-dc22b175f0831
855633diclofenac sodium 1 % Topical GelPSN20ef08a3-35cf-b4d6-e063-6394a90a012e1
855633diclofenac sodium 0.01 MG/MG Topical GelSCD20ef08a3-35cf-b4d6-e063-6394a90a012e1
855633diclofenac sodium 0.01 MG/MG Topical GelSCD67eacd91-8378-47e7-9bad-1e7b685aa9d41
855633diclofenac sodium 0.01 MG/MG Topical GelSCD5f1ca9c1-c7fe-4a91-af5e-dc22b175f0831
855633diclofenac sodium 1 % Topical GelSY67eacd91-8378-47e7-9bad-1e7b685aa9d41
855633diclofenac sodium 1 % Topical GelSY5f1ca9c1-c7fe-4a91-af5e-dc22b175f0831
855633diclofenac sodium 1 % Topical GelSY20ef08a3-35cf-b4d6-e063-6394a90a012e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-1189-01001131189011 TUBE in 1 CARTON (0113-1189-01) / 100 g in 1 TUBE1 tube2020-08-220000-00-00NoNoCurrent
0113-1189-0300113118903150 g in 1 TUBE (0113-1189-03) 150 g2020-11-180000-00-00NoNoCurrent