FDA.reportPublic FDA data

Diclovix M

Product NDC
72275-719
11-digit product format
722750719
Labeler code
72275
Product ID
72275-719_9d001257-2092-2a0c-e053-2a95a90ad767
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium, with camphor, lidocaine, and methyl salicylate patch
Dosage form
KIT
Labeler
Primary Pharmaceuticals, Inc
Application
ANDA202769
Marketing category
ANDA
Marketing start
2018-08-09
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72275-719-772023-01-30C16284748780-1f386c649-f945-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Diclofenac Sodium Topical Solution safely and effectively. See full prescribing information for Diclofenac Sodium Topical Solution.DICLOFENAC Sodium Topical Solution 1.5% w/w is for topical use only. Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-002-05Diclovix M150 mL in 1 BOTTLESOLUTION150 mL16.05 mg in 1mL1
53329-984-16Diclovix M85 g in 1 PACKETGEL85 g80 g in 1000g1
72275-719-77Diclovix M1 in 1 KITKIT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72275-719-77EA - Each72275-71994d2b6f1-f595-4608-ba96-59ecd46e5e1412020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72275-719DICLOVIX M (DICLOFENAC SODIUM, WITH CAMPHOR, LIDOCAINE, AND METHYL SALICYLATE PATCH) KIT [PRIMARY PHARMACEUTICALS, INC]1Legacy NDC, 3 package rows20200126_9d0012ed-a50a-a936-e053-2995a90a6100.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2119857ActivICE 8 % Topical GelPSN9d0012ed-a50a-a936-e053-2995a90a61001
857700diclofenac sodium 1.5 % Topical SolutionPSN9d0012ed-a50a-a936-e053-2995a90a61001
283257menthol 8 % Topical GelPSN9d0012ed-a50a-a936-e053-2995a90a61001
2119857menthol 0.08 MG/MG Topical Gel [ActivICE]SBD9d0012ed-a50a-a936-e053-2995a90a61001
857700diclofenac sodium 15 MG/ML Topical SolutionSCD9d0012ed-a50a-a936-e053-2995a90a61001
283257menthol 0.08 MG/MG Topical GelSCD9d0012ed-a50a-a936-e053-2995a90a61001
2119857ActivICE 0.08 MG/MG Topical GelSY9d0012ed-a50a-a936-e053-2995a90a61001
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY9d0012ed-a50a-a936-e053-2995a90a61001
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY9d0012ed-a50a-a936-e053-2995a90a61001
283257menthol 8 % Topical GelSY9d0012ed-a50a-a936-e053-2995a90a61001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-002-0552565000205150 mL in 1 BOTTLE150 mlHistorical
53329-984-165332909841685 g in 1 PACKET85 gHistorical
72275-719-77722750719771 KIT in 1 KIT (72275-719-77) * 150 mL in 1 BOTTLE (52565-002-05) * 85 g in 1 PACKET (53329-984-16) 1 kit2020-01-200000-00-00NoNoCurrent