FDA.reportPublic FDA data

Diclona

Product NDC
83881-102
11-digit product format
838810102
Labeler code
83881
Product ID
83881-102_32721b87-aeed-d759-e063-6394a90a40d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine 4.5%, Diclofenac 1%
Dosage form
GEL
Route
CUTANEOUS
Labeler
Clinic Pharma
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-04-15
Substance
DICLOFENAC SODIUM; LIDOCAINE
Active strength
.01; .045 g/g; g/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Antiarrhythmic [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Local Anesthesia [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
Diclona
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM.01 g/g
LIDOCAINE.045 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q, 98PI200987
Rxcui2600049

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
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
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83881-102-35Diclona99 g in 1 TUBEGEL991

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83881-102-35GM - Gram83881-102058be183-7186-4ed9-93c0-30609ea0d39d12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83881-102DICLONA (LIDOCAINE 4.5%, DICLOFENAC 1%) GEL [CLINIC PHARMA]1Current NDC, 1 package rows20250416_3271f9ee-6f8a-1c68-e063-6394a90a8e3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2600049diclofenac sodium 1 % / lidocaine HCl 4.5 % Topical GelPSN3271f9ee-6f8a-1c68-e063-6394a90a8e3b1
2600049diclofenac sodium 1 % / lidocaine HCl 4.5 % Topical GelPSN34685ef2-0015-8941-e063-6294a90ad0f71
2600049diclofenac sodium 1 % / lidocaine HCl 4.5 % Topical GelPSN4cc1d80b-2435-404f-949f-bd207a8636311
2600049diclofenac sodium 0.01 MG/MG / lidocaine hydrochloride 0.045 MG/MG Topical GelSCD3271f9ee-6f8a-1c68-e063-6394a90a8e3b1
2600049diclofenac sodium 0.01 MG/MG / lidocaine hydrochloride 0.045 MG/MG Topical GelSCD34685ef2-0015-8941-e063-6294a90ad0f71
2600049diclofenac sodium 0.01 MG/MG / lidocaine hydrochloride 0.045 MG/MG Topical GelSCD4cc1d80b-2435-404f-949f-bd207a8636311
2600049diclofenac sodium 1 % / lidocaine HCl 4.5 % Topical GelSY3271f9ee-6f8a-1c68-e063-6394a90a8e3b1
2600049diclofenac sodium 1 % / lidocaine HCl 4.5 % Topical GelSY34685ef2-0015-8941-e063-6294a90ad0f71
2600049diclofenac sodium 1 % / lidocaine HCl 4.5 % Topical GelSY4cc1d80b-2435-404f-949f-bd207a8636311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83881-102-358388101023599 g in 1 TUBE (83881-102-35) 99 g2025-04-15NoNoHistorical