FDA.reportPublic FDA data

NDC 68788-8952-09 - Diclofenac Sodium Delayed Release

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
68788-8952
Requested NDC
68788-8952-09
Package NDCs from labels
68788-8952-3, 68788-8952-6, 68788-8952-9, 68788-8952-1, 68788-8952-8, 68788-8952-09
Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-04-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diclofenac SodiumPreferred Pharmaceuticals Inc.2026-04-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8952-1Diclofenac SodiumDelayed Release100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE10013
68788-8952-3Diclofenac SodiumDelayed Release30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE3013
68788-8952-6Diclofenac SodiumDelayed Release60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE6013
68788-8952-8Diclofenac SodiumDelayed Release120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE12013
68788-8952-9Diclofenac SodiumDelayed Release90 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE9013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8952DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 5 package rows20250316_e947653c-6789-4c15-82c9-4b1402f6d6ac.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8952-1EA - Each68788-89521a2e62da-2104-4115-a50a-56672d4878a112021-11-09
68788-8952-3EA - Each68788-8952cf00ce8e-bfd3-4206-805e-c7665793fb5612021-11-09
68788-8952-6EA - Each68788-89527e879ae0-9eac-42b9-9180-80bbb273770a12021-11-09
68788-8952-8EA - Each68788-895208a9e51d-852e-4332-870d-80664eafb01112021-11-09
68788-8952-9EA - Each68788-89522fb63b85-5e1e-490f-abc7-3221af78ae7412021-11-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
POLYETHYLENE GLYCOL 2000INACTIVE INGREDIENTHAF0412YITDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
SHELLACINACTIVE INGREDIENT46N107B71ODICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1

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 1 of 124 · 2,465 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutionsd9698809-4887-4514-aa28-0066355ef9082026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMNuCare Pharmaceuticals, Inc.5a852412-69af-6502-e063-6294a90a07482026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855906
unii: QTG126297Q
DiclofenacDICLOFENAC SODIUMYYBA CORP533653e8-93d5-9080-e063-6394a90a165b2026-09-01WarningsExact identifier
unii: QTG126297Q
Diclofenac sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLMylan Pharmaceuticals Inc.a7701e8c-4e16-4165-8b83-de2c08d5ded32026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLActavis Pharma, Inc.df8b8660-0c24-4848-8bea-c1b935090c662026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
DICLOFENAC SODIUMDICLOFENAC SODIUMNorthwind Health Company, LLC5990259d-2f90-20d3-e063-6394a90a3d232026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
unii: QTG126297Q
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
AMAZON BASIC CARE ARTHRITIS PAINDICLOFENAC SODIUMAmazon.com Services LLC113e2f87-c408-3e44-e063-6394a90a0a7f2026-08-20WarningsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENAC SODIUMNorthwind Health Company, LLC4dde6e36-7540-1cc3-e063-6294a90a39412026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855906
unii: QTG126297Q
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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