FDA.reportPublic FDA data

Diclogen

Product NDC
59088-802
11-digit product format
590880802
Labeler code
59088
Product ID
59088-802_463c7ec1-4f7d-598c-e063-6394a90a6d8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium, Camphor and Menthol
Dosage form
KIT
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-07-26
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Diclogen
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
857700Internal RxNorm lookup
1039731Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1e2bb4e5-bb65-48a0-e063-6294a90a54d1Available 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
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-283-07Diclogen85 g in 1 BOTTLE, WITH APPLICATORGEL85 g4 g in 100g3
59088-435-10Diclogen150 mL in 1 BOTTLE, DROPPERSOLUTION150 mL16.05 mg in 1mL3
59088-435-10Diclogen1 in 1 CARTONSOLUTION16.05 mg in 1mL3
59088-802-00Diclogen1 in 1 KITKIT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-802-00EA - Each59088-802d5ff9703-18fb-48a4-826c-7aee02ecb75f12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-802DICLOGEN (DICLOFENAC SODIUM, CAMPHOR AND MENTHOL) KIT [PURETEK CORPORATION]2Current NDC, 4 package rows20241208_1e2bb4e5-bb65-48a0-e063-6294a90a54d1.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
DiclogenDICLOFENAC SODIUM, CAMPHOR AND MENTHOLPureTek Corporation1e2bb4e5-bb65-48a0-e063-6294a90a54d12025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 59088-802

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039731camphor 4 % / menthol 10 % Topical GelPSN1e2bb4e5-bb65-48a0-e063-6294a90a54d13
857700diclofenac sodium 1.5 % Topical SolutionPSN1e2bb4e5-bb65-48a0-e063-6294a90a54d13
1039731camphor 0.04 MG/MG / menthol 0.1 MG/MG Topical GelSCD1e2bb4e5-bb65-48a0-e063-6294a90a54d13
857700diclofenac sodium 15 MG/ML Topical SolutionSCD1e2bb4e5-bb65-48a0-e063-6294a90a54d13
1039731camphor 4 % / menthol 10 % Topical GelSY1e2bb4e5-bb65-48a0-e063-6294a90a54d13
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY1e2bb4e5-bb65-48a0-e063-6294a90a54d13
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY1e2bb4e5-bb65-48a0-e063-6294a90a54d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59088-283-075908802830785 g in 1 BOTTLE, WITH APPLICATOR85 gHistorical
59088-435-1059088043510150 mL in 1 BOTTLE, DROPPER150 mlHistorical
59088-802-00590880802001 KIT in 1 KIT (59088-802-00) * 1 BOTTLE, DROPPER in 1 CARTON (59088-435-10) / 150 mL in 1 BOTTLE, DROPPER * 85 g in 1 BOTTLE, WITH APPLICATOR (59088-283-07) 1 kit2024-07-26NoNoCurrent