FDA.reportPublic FDA data

FLECTOR

Product NDC
71858-0405
11-digit product format
718580405
Labeler code
71858
Product ID
71858-0405_41a95307-60af-f937-e063-6394a90aa82a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac epolamine
Dosage form
SYSTEM
Route
TOPICAL
Labeler
IBSA Pharma Inc.
Application
NDA021234
Marketing category
NDA
Marketing start
2020-11-01
Substance
DICLOFENAC EPOLAMINE
Active strength
.013 g/1
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
FLECTOR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC EPOLAMINE.013 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX5F8EKL9ZG
Rxcui855626, 855628

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
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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71858-0405-1FLECTOR2 in 1 POUCHSYSTEM211
71858-0405-2FLECTOR1 in 1 CARTONSYSTEM111
71858-0405-4FLECTOR5 in 1 POUCHSYSTEM511
71858-0405-5FLECTOR6 in 1 CARTONSYSTEM611
71858-0405-6FLECTOR3 in 1 CARTONSYSTEM311

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71858-0405-4EA - Each71858-04054c0a7a9d-686b-4d38-af69-b5092eeec07d12021-01-08
71858-0405-5EA - Each71858-04056638b071-9509-4b2b-9c5a-9591d20e2c1212021-01-08
71858-0405-6EA - Each71858-0405f5d186a1-a103-4002-8b74-4495c5269a3512026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71858-0405FLECTOR (DICLOFENAC EPOLAMINE) SYSTEM [IBSA PHARMA INC.]10Current NDC, Legacy NDC, 5 package rows20241220_1f19a016-c4fc-43c5-9990-e5f2e2776a82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855626diclofenac epolamine 1.3 % Twice-Daily Medicated PatchPSN1f19a016-c4fc-43c5-9990-e5f2e2776a8211
855628Flector 1.3 % Twice-Daily Medicated PatchPSN1f19a016-c4fc-43c5-9990-e5f2e2776a8211
855628Twice-Daily diclofenac epolamine 0.013 MG/MG Medicated Patch [Flector]SBD1f19a016-c4fc-43c5-9990-e5f2e2776a8211
855626Twice-Daily diclofenac epolamine 0.013 MG/MG Medicated PatchSCD1f19a016-c4fc-43c5-9990-e5f2e2776a8211
855626diclofenac epolamine 1.3 % Twice-Daily Medicated PatchSY1f19a016-c4fc-43c5-9990-e5f2e2776a8211
855628Flector 1.3 % Twice-Daily Medicated PatchSY1f19a016-c4fc-43c5-9990-e5f2e2776a8211
855628Twice-Daily Flector 0.013 MG/MG Medicated PatchSY1f19a016-c4fc-43c5-9990-e5f2e2776a8211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71858-0405-1718580405012 in 1 POUCHHistorical
71858-0405-2718580405021 POUCH in 1 CARTON (71858-0405-2) / 2 SYSTEM in 1 POUCH (71858-0405-1) 1 pouch2020-11-010000-00-00YesNoCurrent
71858-0405-4718580405045 in 1 POUCHHistorical
71858-0405-5718580405056 POUCH in 1 CARTON (71858-0405-5) / 5 SYSTEM in 1 POUCH (71858-0405-4) 6 pouch2020-11-010000-00-00NoNoCurrent
71858-0405-6718580405063 POUCH in 1 CARTON (71858-0405-6) / 5 SYSTEM in 1 POUCH (71858-0405-4) 3 pouch2026-02-01NoNoHistorical