FDA.reportPublic FDA data

Xiclofen

Product NDC
83295-5050
11-digit product format
832955050
Labeler code
83295
Product ID
83295-5050_35a73eb0-39ac-30d4-e063-6294a90a97d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium, methyl salicylate
Dosage form
OINTMENT
Route
CUTANEOUS
Labeler
STRAND HEALTH GROUP
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-02-07
Substance
DICLOFENAC SODIUM; METHYL SALICYLATE
Active strength
.01; .05 g/g; 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
Xiclofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM.01 g/g
METHYL SALICYLATE.05 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QTG126297QInternal UNII lookup
LAV5U5022YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2704846Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d92d378-2e9c-f9d5-e063-6294a90ac715Available 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
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
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
83295-5050-1Xiclofen85 g in 1 TUBEOINTMENT852
83295-5050-1Xiclofen1 in 1 BOXOINTMENT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83295-5050-1GM - Gram83295-50507067b793-28cb-4ef7-a531-6d7a5851061712025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83295-5050XICLOFEN (DICLOFENAC SODIUM, METHYL SALICYLATE) OINTMENT [STRAND HEALTH GROUP]2Current NDC, 2 package rows20250523_2d92d378-2e9c-f9d5-e063-6294a90ac715.zip

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
XiclofenDICLOFENAC SODIUM, METHYL SALICYLATESTRAND HEALTH GROUP2d92d378-2e9c-f9d5-e063-6294a90ac7152025-05-21WarningsExact identifier
ndc (product): 83295-5050

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2704846diclofenac sodium 1 % / methyl salicylate 5 % Topical OintmentPSN2d92d378-2e9c-f9d5-e063-6294a90ac7152
2704846diclofenac sodium 0.01 MG/MG / methyl salicylate 0.05 MG/MG Topical OintmentSCD2d92d378-2e9c-f9d5-e063-6294a90ac7152
2704846diclofenac sodium 1 % / methyl salicylate 5 % Topical OintmentSY2d92d378-2e9c-f9d5-e063-6294a90ac7152
2704846diclofenac sodium 1 % / methyl salicylate 5 % Topical OintmentPSN263f64d5-da3e-43cc-a651-2136f3b1f2ea1
2704846diclofenac sodium 0.01 MG/MG / methyl salicylate 0.05 MG/MG Topical OintmentSCD263f64d5-da3e-43cc-a651-2136f3b1f2ea1
2704846diclofenac sodium 1 % / methyl salicylate 5 % Topical OintmentSY263f64d5-da3e-43cc-a651-2136f3b1f2ea1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83295-5050-1832955050011 TUBE in 1 BOX (83295-5050-1) / 85 g in 1 TUBE1 tube2025-02-07NoNoCurrent