FDA.reportPublic FDA data

DermasilkRx DicloPak

Product NDC
69329-335
11-digit product format
693290335
Labeler code
69329
Product ID
69329-335_1cc112b0-ac7f-3ecf-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium delayed release tablets, capsaicin cream
Dosage form
KIT
Labeler
Patchwerx Labs, Inc.
Application
ANDA074514
Marketing category
ANDA
Marketing start
2015-08-06
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
E
Listing certified through
2017-12-31
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
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
69329-335-002020-01-31C16284748780-19d75b9d0-a6c3-f424-e053-dadaa90a57ce1cac4fd0-70cb-2bbf-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0228-2551-06DermasilkRx DicloPak60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE6075 mg2
69329-335-00DermasilkRx DicloPak1 in 1 PACKAGEKIT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69329-335-00EA - Each69329-335ee5b18da-6510-4f9c-a2b9-61127a28e42512015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSICUM OLEORESINACTIVE INGREDIENTUW86K581WYDERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]2
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]2
CAPSICUM OLEORESINACTIVE MOIETYUW86K581WYDERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]2
DICLOFENACACTIVE MOIETY144O8QL0L1DERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]2
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQDERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69329-335DERMASILKRX DICLOPAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, CAPSAICIN CREAM) KIT [PATCHWERX LABS, INC.]2Legacy NDC, 2 package rows20150808_1cac4fd0-70cb-2bbf-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN1cac4fd0-70cb-2bbf-e054-00144ff8d46c2
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD1cac4fd0-70cb-2bbf-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0228-2551-060022825510660 in 1 BOTTLE, PLASTICHistorical
69329-335-00693290335001 in 1 PACKAGEHistorical