FDA.reportPublic FDA data

Arthritis Pain Reliever

Product NDC
46122-752
11-digit product format
461220752
Labeler code
46122
Product ID
46122-752_64583277-4362-4eeb-90a9-e22d75377ff4
Type
HUMAN OTC DRUG
Nonproprietary name
Diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
AmerisourceBergen (Good Neighbor Pharmacy) 46122
Application
ANDA208077
Marketing category
ANDA
Marketing start
2023-04-01
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
Arthritis Pain Reliever
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
46122-752-37Arthritis Pain Reliever1 in 1 CARTONGEL15
46122-752-37Arthritis Pain Reliever50 g in 1 TUBEGEL505
46122-752-52Arthritis Pain Reliever1 in 1 CARTONGEL15
46122-752-52Arthritis Pain Reliever100 g in 1 TUBEGEL1005
46122-752-53Arthritis Pain Reliever1 in 1 CARTONGEL15
46122-752-53Arthritis Pain Reliever150 g in 1 TUBEGEL1505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-752-37GM - Gram46122-7527dd8a11c-955a-40ed-9468-246ab088199d12023-09-05
46122-752-52GM - Gram46122-752e446f456-5f1b-4eb6-b15f-2c445a82dd3e12023-10-16
46122-752-53GM - Gram46122-752c2efa5ff-41b8-46af-a27c-96dfe429526512023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-752ARTHRITIS PAIN RELIEVER (DICLOFENAC SODIUM) GEL [AMERISOURCEBERGEN (GOOD NEIGHBOR PHARMACY) 46122]5Current NDC, 6 package rows20230810_30e1f589-b322-48b7-9a97-502afe2a1baa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSN30e1f589-b322-48b7-9a97-502afe2a1baa5
855633diclofenac sodium 0.01 MG/MG Topical GelSCD30e1f589-b322-48b7-9a97-502afe2a1baa5
855633diclofenac sodium 1 % Topical GelSY30e1f589-b322-48b7-9a97-502afe2a1baa5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46122-752-37461220752371 TUBE in 1 CARTON (46122-752-37) / 50 g in 1 TUBE1 tube2023-04-01NoNoCurrent
46122-752-52461220752521 TUBE in 1 CARTON (46122-752-52) / 100 g in 1 TUBE1 tube2023-04-01NoNoCurrent
46122-752-53461220752531 TUBE in 1 CARTON (46122-752-53) / 150 g in 1 TUBE1 tube2023-04-01NoNoCurrent