FDA.reportPublic FDA data

Flector

Product NDC
42254-248
11-digit product format
422540248
Labeler code
42254
Product ID
42254-248_2b810942-e143-4e4f-8820-00af4f2e0c1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Epolamine
Dosage form
PATCH
Route
TOPICAL
Labeler
Rebel Distributors Corp
Application
NDA021234
Marketing category
NDA
Marketing start
2008-01-14
Marketing end
0000-00-00
Substance
DICLOFENAC EPOLAMINE
Active strength
180 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-248-302019-09-24C16284748780-19350213a-3db2-c013-e053-90daa90a1393These highlights do not include all the information needed to use FLECTOR® PATCH 1.3% safely and effectively. See full prescribing information for FLECTOR PATCH. FLECTOR PATCH® (diclofenac epolamine patch) 1.3% Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-248-30Flector6 in 1 CARTONPATCH61
42254-248-30Flector5 in 1 POUCHPATCH51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-248-30EA - Each42254-24850cc8cb7-1c07-4634-a654-268abf9f58e312013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diclofenac EpolamineACTIVE INGREDIENTX5F8EKL9ZGFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]1
DiclofenacACTIVE MOIETY144O8QL0L1FLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]1
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RAFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]1
Carboxymethylcellulose SodiumINACTIVE INGREDIENTK679OBS311FLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]1
Dihydroxyaluminum AminoacetateINACTIVE INGREDIENTDO250MG0W6FLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]1
GelatinINACTIVE INGREDIENT2G86QN327LFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]1
KaolinINACTIVE INGREDIENT24H4NWX5COFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3FLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]1
SorbitolINACTIVE INGREDIENT506T60A25RFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]1
Tartaric AcidINACTIVE INGREDIENTW4888I119HFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]1
WaterINACTIVE INGREDIENT059QF0KO0RFLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-248FLECTOR (DICLOFENAC EPOLAMINE) PATCH [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20130221_2b810942-e143-4e4f-8820-00af4f2e0c1e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855626diclofenac epolamine 1.3 % Twice-Daily Medicated PatchPSN2b810942-e143-4e4f-8820-00af4f2e0c1e1
855628Flector 1.3 % Twice-Daily Medicated PatchPSN2b810942-e143-4e4f-8820-00af4f2e0c1e1
855628Twice-Daily diclofenac epolamine 0.013 MG/MG Medicated Patch [Flector]SBD2b810942-e143-4e4f-8820-00af4f2e0c1e1
855626Twice-Daily diclofenac epolamine 0.013 MG/MG Medicated PatchSCD2b810942-e143-4e4f-8820-00af4f2e0c1e1
855626diclofenac epolamine 1.3 % Twice-Daily Medicated PatchSY2b810942-e143-4e4f-8820-00af4f2e0c1e1
855628Flector 1.3 % Twice-Daily Medicated PatchSY2b810942-e143-4e4f-8820-00af4f2e0c1e1
855628Twice-Daily Flector 0.013 MG/MG Medicated PatchSY2b810942-e143-4e4f-8820-00af4f2e0c1e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-248-30422540248306 in 1 CARTONHistorical