FDA.reportPublic FDA data

NDC 0054-4223 - 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
0054-4223
Package NDCs from labels
0054-4223-25
Manufacturer
Boehringer Ingelheim Roxane Laboratories
Effective date
2006-08-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diclofenac Sodium - Boehringer Ingelheim Roxane LaboratoriesBoehringer Ingelheim Roxane Laboratories2006-08-30Human prescription drug label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-4223-25Diclofenac Sodium100 in 1 BOTTLE, PLASTICTABLET1001
0054-8223-25Diclofenac Sodium100 in 1 BLISTER PACKTABLET1001
0054-8223-25Diclofenac Sodium10 in 1 PACKAGETABLET101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-4223DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]13 package rows20060921_A4FD2D68-019F-4C89-8923-4E61262F6EEE.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
diclofenac sodiumACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
black iron oxideINACTIVE INGREDIENTDICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
colloidal silicon dioxideINACTIVE INGREDIENTDICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
croscarmellose sodiumINACTIVE INGREDIENTDICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
FD&C Blue No. 2INACTIVE INGREDIENTDICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
FD&C Red No. 40INACTIVE INGREDIENTDICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
FD&C Yellow No. 6INACTIVE INGREDIENTDICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
lactose monhydrateINACTIVE INGREDIENTDICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
lactose monohydrateINACTIVE INGREDIENTDICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
magnesium stearateINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
methacrylic acid copolymerINACTIVE INGREDIENTDICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
methylparabenINACTIVE INGREDIENTDICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
microcrystalline celluloseINACTIVE INGREDIENTDICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
n-butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
polysorbate 80INACTIVE INGREDIENTDICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
potassium sorbateINACTIVE INGREDIENTDICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
pregelatinized starchINACTIVE INGREDIENTDICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHDICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRDICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JDICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APDICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
talcINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
triethyl citrateINACTIVE INGREDIENTDICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]1
xanthan gumINACTIVE INGREDIENTDICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET [BOEHRINGER INGELHEIM ROXANE LABORATORIES]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 2 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMRedpharm Drug4cd2e51b-2019-6eb6-e063-6294a90ad7ef2026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions337c2253-34c1-4611-88c9-d558507255a22026-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
Diclofenac SodiumDICLOFENAC SODIUMBryant Ranch Prepack03c4f06f-6a49-4404-bf3b-0aafa33c81ef2026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions0cefb675-c54e-44eb-b35c-38354b77eddd2026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855906
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions74011b00-7e2e-40a7-ab30-c05a205598142026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855906
Diclofenac SodiumDICLOFENAC SODIUMUmedica Laboratories USA Inc.0e5c6669-390f-4c32-b9b8-13ed3c5174622026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
rxcui: 855906
rxcui: 855664
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMGolden State Medical Supply, Inc.468fab22-2b69-4a2c-e063-6294a90aab9a2026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
rxcui: 855906
rxcui: 855664
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.4ee64a93-9965-47c8-be2c-14232df44b2b2026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855906
DICLOFENAC SODIUMDICLOFENAC SODIUMA-S Medication Solutionsf92576d7-3ad9-43a3-8b10-3a29fbf712a42026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
DICLOFENAC SODIUMDICLOFENAC SODIUMA-S Medication Solutions6c57e330-ebbe-4165-84a8-4844b2f0097e2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions47793dca-5e9e-44ee-8e66-5e42e1831b1e2026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
rxcui: 855906
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutionsb74be49d-74ff-491b-962b-0edd3a57cbc92026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855906
Diclofenac SodiumDICLOFENAC SODIUMAvKARE19b4ff5c-adb7-a0d0-7ef2-4ae05047fd942026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
rxcui: 855906
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMREMEDYREPACK INC.14c1b1a1-bc06-4722-9612-e88ae52272bc2026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855906
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions1e669fc2-69bf-4439-a336-a103e5b9cafe2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
rxcui: 855906
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions8825dc2c-3497-455f-b5e1-2aa6672919572026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855906
Diclofenac SodiumDICLOFENAC SODIUMPHOENIX RX LLC47ce6fab-be1d-0076-e063-6294a90add632026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMNorthwind Health Company, LLCc16e7e43-3869-9fef-e053-2995a90a1fdb2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855926
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMNorthwind Health Company, LLCf2b7ea75-738b-54a8-e053-2995a90a00d52026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855906
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLC47a7a294-55bb-8d19-e063-6394a90a54402025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 855906

Reported adverse events (FAERS/openFDA)#

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