FDA.reportPublic FDA data

Xiclo

Product NDC
83295-5500
11-digit product format
832955500
Labeler code
83295
Product ID
83295-5500_463f4bb7-e16f-4966-e063-6294a90a58eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Strand Health Group
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-02-07
Substance
DICLOFENAC
Active strength
.0125 g/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
Xiclo
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC.0125 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii144O8QL0L1
Rxcui2705052, 2705057

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
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
83295-5500-1Xiclo2 in 1 POUCHPATCH24
83295-5500-1Xiclo5 in 1 BOXPATCH54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83295-5500-1EA - Each83295-550019adca9e-9a97-43fe-8730-c73405bb751812025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83295-5500XICLO (DICLOFENAC) PATCH [STRAND HEALTH GROUP]3Current NDC, 2 package rows20250523_2d93a01c-40a9-8fb0-e063-6394a90a2cc6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2705052diclofenac 1.25 % Medicated PatchPSN2d93a01c-40a9-8fb0-e063-6394a90a2cc64
2705057Xiclo 1.25 % Medicated PatchPSN2d93a01c-40a9-8fb0-e063-6394a90a2cc64
2705057diclofenac 0.0125 MG/MG Medicated Patch [Xiclo]SBD2d93a01c-40a9-8fb0-e063-6394a90a2cc64
2705052diclofenac 0.0125 MG/MG Medicated PatchSCD2d93a01c-40a9-8fb0-e063-6394a90a2cc64
2705052diclofenac 1.25 % Medicated PatchSY2d93a01c-40a9-8fb0-e063-6394a90a2cc64
2705057Xiclo 0.0125 MG/MG Medicated PatchSY2d93a01c-40a9-8fb0-e063-6394a90a2cc64
2705052diclofenac 1.25 % Medicated PatchPSN71cd0d4e-671c-4372-9b1f-7b34cf8878241
2705057Xiclo 1.25 % Medicated PatchPSN71cd0d4e-671c-4372-9b1f-7b34cf8878241
2705057diclofenac 0.0125 MG/MG Medicated Patch [Xiclo]SBD71cd0d4e-671c-4372-9b1f-7b34cf8878241
2705052diclofenac 0.0125 MG/MG Medicated PatchSCD71cd0d4e-671c-4372-9b1f-7b34cf8878241
2705052diclofenac 1.25 % Medicated PatchSY71cd0d4e-671c-4372-9b1f-7b34cf8878241
2705057Xiclo 0.0125 MG/MG Medicated PatchSY71cd0d4e-671c-4372-9b1f-7b34cf8878241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83295-5500-1832955500015 POUCH in 1 BOX (83295-5500-1) / 2 PATCH in 1 POUCH / 2.7 g in 1 PATCH5 pouch2025-02-07NoNoHistorical