FDA.reportPublic FDA data

DICLOFENAC

Substance profile for UNII 144O8QL0L1, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for DICLOFENAC
Structure render from PubChem CID 3033

Substance Identity#

UNII
144O8QL0L1
Preferred term
DICLOFENAC
Registry number
15307-86-5
EC number
239-348-5
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C14H11Cl2NO2
Chemical structure for DICLOFENAC
Structure render from PubChem CID 3033

Chemical And Database Identifiers#

InChIKey
DCOPUUMXTXDBNB-UHFFFAOYSA-N
SMILES
OC(=O)CC1=CC=CC=C1NC2=C(Cl)C=CC=C2Cl
RxCUI
3355
PubChem
3033
NCIt
C28985
INN ID
3270

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem Compound3033pubchem.ncbi.nlm.nih.gov/compound/3033
PubChem InChIKey SearchDCOPUUMXTXDBNB-UHFFFAOYSA-Npubchem.ncbi.nlm.nih.gov/#query=DCOPUUMXTXDBNB-UHFFFAOYSA-N
RxNorm3355mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=3355
NCI ThesaurusC28985ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C28985
FDA Substance Registration System144O8QL0L1precision.fda.gov/uniisearch/srs/unii/144O8QL0L1
European Community number239-348-5commonchemistry.cas.org/results?q=239-348-5

DailyMed Socrata Ingredients#

Type, DailyMed label, SPL version table
TypeDailyMed labelSPL version
ACTIVE MOIETYInflamation Reduction Pack These highlights do not include all the information needed to use Inflammation Reduction Pack safely and effectively.see full prescribing information for Inflammation Reduction Pack Inflammation Reduction Pack (Inflammation Reduction Pack) KIT for use. Initial U.S. Approval:4
ACTIVE MOIETYDICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP 40-9184 Revised – August 2015 Rx Only Prescribing Information2
ACTIVE MOIETYInflamation Reduction Pack These highlights do not include all the information needed to use Inflammation Reduction Pack safely and effectively.see full prescribing information for Inflammation Reduction Pack Inflammation Reduction Pack (Inflammation Reduction Pack) KIT for use. Initial U.S. Approval:3
ACTIVE MOIETYDiclofenac Sodium Extended-release Tablets8
ACTIVE MOIETYDiclofenac Sodium and Misoprostol Delayed-Release Tablets1
ACTIVE MOIETYDiclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg2
ACTIVE MOIETYDiclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg1
ACTIVE MOIETYInflamation Reduction Pack2
ACTIVE MOIETYVOLTAREN2
ACTIVE MOIETY1cac4fd0-70cb-2bbf-e054-00144ff8d46c2
ACTIVE MOIETY1c948de4-dbbf-309a-e054-00144ff8d46c1
ACTIVE MOIETY1b49b08b-8494-3f71-e054-00144ff88e881
ACTIVE MOIETYDICLOFENAC SODIUM1
ACTIVE MOIETYDiclofenac Sodium Delayed-release Tablets, USP 40-9184 Revised – June 20121
ACTIVE MOIETYDICLOFENAC SODIUM1
ACTIVE MOIETYDiclofenac Sodium Extended-Release Tablets, USP Tablets of 100 mg Rx only Prescribing Information2
ACTIVE MOIETYDiclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg6
ACTIVE MOIETYDiclofenac sodium and misoprostol delayed-release tablets3
ACTIVE MOIETYDiclofenac Sodium Extended-Release Tablets, USP Tablets of 100 mg Rx only Prescribing Information2
ACTIVE MOIETYDiclofenac Sodium Delayed-Release Tablets USP1
ACTIVE MOIETYDICLOFENAC POTASSIUM TABLETS USP, 50 mg 0948 Rx only1
ACTIVE MOIETYDiclofenac Sodium Delayed-release Tablets, USP 40-9184 Revised – June 20122
ACTIVE MOIETYDICLOFENAC POTASSIUM, TABLET USP1
ACTIVE MOIETYDiclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg1
ACTIVE MOIETYDiclofenac Sodium Delayed-Release Tablets USP4
ACTIVE MOIETYDiclofenac Sodium Extended-Release Tablets, USP Tablets of 100 mg Rx only Prescribing Information2
ACTIVE MOIETYDICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP3
ACTIVE MOIETYDiclofenac Sodium Delayed-release Tablets, USP2
ACTIVE MOIETYVOLTAREN OPHTHAMIC ® (diclofenac sodium ophthalmic solution) 0.1% Sterile Ophthalmic Solution Rx only Prescribing Information7
ACTIVE MOIETYDICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USP2
ACTIVE MOIETYDiclofenac Sodium Delayed-release Tablets, USP 40-8780 Revised – March 20111
ACTIVE MOIETYThese highlights do not include all the information needed to use FLECTOR® PATCH 1.3% safely and effectively. See full prescribing information for FLECTOR PATCH. FLECTOR PATCH® (diclofenac epolamine patch) 1.3% Initial U.S. Approval: 19881
ACTIVE MOIETYDiclofenac Sodium Delayed-release Tablets, USP 50 mg1
ACTIVE MOIETYARTHROTEC ® (diclofenac sodium/misoprostol) Tablets1
ACTIVE MOIETYDiclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg3
ACTIVE MOIETYThese highlights do not include all the information needed to use CAMBIA safely and effectively. See full prescribing information for CAMBIA. CAMBIA (Diclofenac Potassium for Oral Solution) Initial U.S. Approval: 19884
ACTIVE MOIETYThese highlights do not include all the information needed to use Voltaren® Gel safely and effectively. See full prescribing information for Voltaren® Gel. Initial U.S. Approval: 19885
ACTIVE MOIETYFlector® Patch (diclofenac epolamine topical patch) 1.3%6
ACTIVE MOIETYDICLOFENAC SOD DR4
ACTIVE MOIETYDiclofenac Sodium Delayed-Release Tablets USP1
ACTIVE MOIETYThese highlights do not include all the information needed to use FLECTOR® PATCH 1.3% safely and effectively. See full prescribing information for FLECTOR PATCH. FLECTOR PATCH® (diclofenac epolamine patch) 1.3% Initial U.S. Approval: 19883
ACTIVE MOIETYARTHROTEC ® (diclofenac sodium/misoprostol) Tablets5
ACTIVE MOIETYThese highlights do not include all the information needed to use Voltaren® Gel safely and effectively. See full prescribing information for Voltaren® Gel. Initial U.S. Approval: 19881
ACTIVE MOIETYDiclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg1
ACTIVE MOIETYDiclofenac Sodium Ophthalmic Solution, 0.1% (Sterile)1
ACTIVE MOIETYDICLOFENAC POTASSIUM TABLETS USP, 50 mg 0948 Rx only1
ACTIVE MOIETYDICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP1
ACTIVE MOIETYThese highlights do not include all the information needed to use Voltaren® Gel safely and effectively. See full prescribing information for Voltaren® Gel. Initial U.S. Approval: 19881
ACTIVE MOIETYDiclofenac Sodium Ophthalmic Solution, 0.1% (Sterile)2
ACTIVE MOIETYbd27460e-46ff-4450-a4f2-a41420c1f93d2
ACTIVE MOIETY42fcf2b5-3466-4493-8a47-c4675538ece31
ACTIVE MOIETYThese highlights do not include all the information needed to use Voltaren® Gel safely and effectively. See full prescribing information for Voltaren® Gel. Initial U.S. Approval: 19881
ACTIVE MOIETYThese highlights do not include all the information needed to use PENNSAID ® safely and effectively. See full prescribing information for PENNSAID. PENNSAID (diclofenac sodium topical solution) 1.5% w/w is for topical use only. Initial U.S. Approval: 19881
ACTIVE MOIETYFlector® Patch (diclofenac epolamine topical patch) 1.3%2
ACTIVE MOIETYDICLOFENAC POTASSIUM TABLETS USP, 50 mg 0948 Rx only1
ACTIVE MOIETYDiclofenac Sodium Ophthalmic Solution, 0.1% (Sterile)1
ACTIVE MOIETYDiclofenac Sodium Delayed-release Tablets, USP 75 mg1
ACTIVE MOIETY5e46b7e9-e640-4db5-882f-73a5dd2482d21
ACTIVE MOIETYThese highlights do not include all the information needed to use Voltaren® Gel safely and effectively. See full prescribing information for Voltaren® Gel. Initial U.S. Approval: 19881
ACTIVE MOIETYDICLOFENAC POTASSIUM TABLETS USP, 50 mg 0948 Rx only1
ACTIVE MOIETYARTHROTEC ® (diclofenac sodium/misoprostol) Tablets1
ACTIVE MOIETYDICLOFENAC POTASSIUM tablet, film coated2
ACTIVE MOIETYdiclofenac sodium (Diclofenac Sodium) tablet2
ACTIVE MOIETYDICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USP1
ACTIVE MOIETYDiclofenac Sodium Ophthalmic Solution, 0.1%1
ACTIVE MOIETYDICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3965
ACTIVE MOIETYDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3744
ACTIVE MOIETYARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3585
ACTIVE MOIETYDICLOFENAC POTASSIUM TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3318
ACTIVE MOIETYVOLTAREN (DICLOFENAC SODIUM) GEL [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3191
ACTIVE MOIETYFLECTOR (DICLOFENAC EPOLAMINE ) PATCH [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3142
ACTIVE MOIETYZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS]2043
ACTIVE MOIETYDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1001
ACTIVE MOIETYDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYFLECTOR (DICLOFENAC EPOLAMINE) PATCH [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYVOLTAREN (DICLOFENAC SODIUM) GEL [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]22
ACTIVE MOIETYARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]21
ACTIVE MOIETYDICLOFENAC SODIUM TABLET, DELAYED RELEASE [SANDOZ INC]15
ACTIVE MOIETYDICLOFENAC POTASSIUM TABLET, FILM COATED [SANDOZ INC]14
ACTIVE MOIETYDICLOFENAC POTASSIUM (DICLOFENAC POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]13
ACTIVE MOIETYDICLOFENAC SODIUM TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]12
ACTIVE MOIETYDICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]12
ACTIVE MOIETYPENNSAID (DICLOFENAC SODIUM) SOLUTION [MALLINCKRODT, INC]12
ACTIVE MOIETYARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]10
ACTIVE MOIETYDICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
ACTIVE MOIETYPENNSAID (DICLOFENAC SODIUM) LIQUID [MALLINCKRODT, INC]10
ACTIVE MOIETYDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC.]8
ACTIVE MOIETYDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
ACTIVE MOIETYDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.]7
ACTIVE MOIETYDICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]7
ACTIVE MOIETYDICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]7
ACTIVE MOIETYDICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]7
ACTIVE MOIETYDICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]7
ACTIVE MOIETYZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [DEPOMED, INC.]7
ACTIVE MOIETYCATAFLAM (DICLOFENAC POTASSIUM) TABLET, SUGAR COATED [NOVARTIS PHARMACEUTICALS CORPORATION]6
ACTIVE MOIETYDICLOFENAC POTASSIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]6
ACTIVE MOIETYDICLOFENAC SODIUM SOLUTION [ACTAVIS PHARMA, INC.]6
ACTIVE MOIETYDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]6
ACTIVE MOIETYFLECTOR (DICLOFENAC EPOLAMINE) PATCH [KING PHARMACEUTICALS, INC.]6
ACTIVE MOIETYSOLARAZE (DICLOFENAC SODIUM) GEL [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.]6
ACTIVE MOIETYVOLTAREN (DICLOFENAC SODIUM) GEL [ENDO PHARMACEUTICALS INC.]6
ACTIVE MOIETYZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [PD-RX PHARMACEUTICALS, INC.]6
ACTIVE MOIETYDICLOFENAC POTASSIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]5
ACTIVE MOIETYDICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]5
ACTIVE MOIETYDICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [ST MARYS MEDICAL PARK PHARMACY]5
ACTIVE MOIETYDICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]5
ACTIVE MOIETYDICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
ACTIVE MOIETYDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]5
ACTIVE MOIETYDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
ACTIVE MOIETYARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [BRYANT RANCH PREPACK]4
ACTIVE MOIETYDICLOFENAC SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
ACTIVE MOIETYDICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]4
ACTIVE MOIETYDICLOFENAC SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4
ACTIVE MOIETYDICLOFENAC SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4
ACTIVE MOIETYDICLOFENAC SODIUM TABLET, DELAYED RELEASE [ST MARYS MEDICAL PARK PHARMACY]4
ACTIVE MOIETYDICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]4
ACTIVE MOIETYZORVOLEX (DICLOFENAC) CAPSULE [IROKO PHARMACEUTICALS LLC]4
ACTIVE INGREDIENTZORVOLEX (DICLOFENAC) CAPSULE [IROKO PHARMACEUTICALS LLC]4