FDA.reportPublic FDA data

Xiclo

Product NDC
83295-5500
Requested package NDC
83295-5500-1
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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XicloDICLOFENACStrand Health Group2d93a01c-40a9-8fb0-e063-6394a90a2cc62025-12-18WarningsExact identifier
ndc (package): 83295-5500-1
ndc (product): 83295-5500
ndc11 (package): 83295550001

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
144O8QL0L1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2705052Internal RxNorm lookup
2705057Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d93a01c-40a9-8fb0-e063-6394a90a2cc6Available on FDA.report

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 pouch2025-02-07NoNoCurrent