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

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui857700, 1039731

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

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 kit2024-07-26NoNoHistorical