FDA.reportPublic FDA data

NDC 68071-3665-01 - Diclofenac Sodium

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68071-3665
Requested NDC
68071-3665-01
Package NDCs from labels
68071-3665-1, 68071-3665-01
Manufacturer
NuCare Pharmaceuticals, Inc.
Effective date
2024-08-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diclofenac Sodium - NuCare Pharmaceuticals, Inc.NuCare Pharmaceuticals, Inc.2024-08-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3665-1Diclofenac Sodium1 in 1 CARTONGEL11
68071-3665-1Diclofenac Sodium100 g in 1 TUBEGEL1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3665DICLOFENAC SODIUM GEL [NUCARE PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20240820_200c2800-a703-e138-e063-6394a90acc09.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 53 of 68 · 1,351 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87c92497-8a51-4977-87fe-e0b4c6bafb192024-09-27WarningsExact identifier
unii: 6DC9Q167V3
good sense arthritis painDICLOFENAC SODIUMA-S Medication Solutions5f1ca9c1-c7fe-4a91-af5e-dc22b175f0832024-09-26WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM TOPICAL GEL, 1%,A-S Medication Solutions4500bf3c-394b-4397-8751-8dac2097fc412024-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855633
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.22f4b8aa-902f-a860-e063-6394a90ada262024-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Soothe Night TimeWHITE PETROLATUM MINERAL OILBausch & Lomb Incorporated638d3c3f-9960-43da-956e-0e28c77f533e2024-09-24WarningsExact identifier
unii: T5L8T28FGP
Soothe XP Preservative FreeLIGHT MINERAL OIL AND MINERAL OILBausch & Lomb Incorporatedb254d885-6d49-4c95-b6be-cfdad49c85e62024-09-20WarningsExact identifier
unii: T5L8T28FGP
Soothe XPLIGHT MINERAL OIL AND MINERAL OILBausch & Lomb Incorporatedc0f053da-8d22-433e-a36e-79cf15ad387f2024-09-20WarningsExact identifier
unii: T5L8T28FGP
SootheGLYCERIN AND PROPYLENE GLYCOLBausch & Lomb Incorporatedfef002ea-c4bd-4486-a42e-1bbd9d73d28d2024-09-20WarningsExact identifier
unii: 6DC9Q167V3
WalmartISOPROPYL ALCOHOLWalmart Inc.d2b9f182-c341-c3b0-e053-2a95a90ac5a72024-09-18WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC2216a551-9fbe-3721-e063-6294a90af13d2024-09-14WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLembecta Medical II, LLCe9576c62-6b6e-4c51-a162-0f93f7ffd7dd2024-09-13WarningsExact identifier
unii: ND2M416302
Gencare-Arthritis Pain ReliefDICLOFENAC SODIUMPioneer Life Sciences, LLC4b1438bb-8591-4237-abcb-91491f34ad8f2024-09-10WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
Leader Preservative-Free Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Health2a2aa620-ca63-4698-88fd-fc263b8fa0d12024-09-07WarningsExact identifier
unii: 6DC9Q167V3
ammonia inhalantsINHALANTEpic Medical Supply Corp20e849e5-8517-b9fd-e063-6394a90a0d232024-09-03WarningsExact identifier
unii: 5138Q19F1X
Isopropyl AlcoholISOPROPYL ALCOHOLWildman Business Group1fd15c0f-7119-0712-e063-6294a90a96252024-09-01WarningsExact identifier
unii: ND2M416302
diclofenac sodiumDICLOFENAC SODIUMNuCare Pharmaceuticals, Inc.20ef08a3-35cf-b4d6-e063-6394a90a012e2024-08-30WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMHarris Teeter17ed520d-bfbe-4a33-e063-6394a90aa0f62024-08-30WarningsExact identifier
rxcui: 855633
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals, Inc.200c2800-a703-e138-e063-6394a90acc092024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA209903
ndc (package): 68071-3665-1
ndc (product): 68071-3665
ndc11 (package): 68071366501
rxcui: 855633
spl id: 200c11a5-d944-b7ba-e063-6394a90a590f
spl set id: 200c2800-a703-e138-e063-6394a90acc09
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepack2bebda5e-227e-4a49-80e3-191cfc8052952024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLRite Aid Corporation8e1f223a-a3a0-4837-9847-2a3939fcc5952024-08-15WarningsExact identifier
unii: T5L8T28FGP

Reported adverse events (FAERS/openFDA)#

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