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 Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q, LAV5U5022Y
Rxcui2704846

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

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 tube2025-02-07NoNoHistorical