FDA.reportPublic FDA data

NDC 65697-450 - Clanza CR

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
65697-450
Package NDCs from labels
65697-450-20, 65697-450-21, 65697-450-22
Manufacturer
United Douglas Pharm., Inc. | Korea United Pharm Inc.
Effective date
2011-11-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Clanza CR - United Douglas Pharm., Inc. | Korea United Pharm Inc.United Douglas Pharm., Inc. | Korea United Pharm Inc.2011-11-02HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65697-450-202019-11-13C16284748780-197449f38-bb73-f6ea-e053-dbdaa90aa7038a023942-01e8-4849-aa3c-1a640ffc7fd3
65697-450-222019-11-13C16284748780-197449f38-bb73-f6ea-e053-dbdaa90aa7038a023942-01e8-4849-aa3c-1a640ffc7fd3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65697-450-20ClanzaCR1 in 1 PACKETTABLET, FILM COATED17
65697-450-21ClanzaCR10 in 1 BLISTER PACKTABLET, FILM COATED107
65697-450-22ClanzaCR10 in 1 CARTONTABLET, FILM COATED107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65697-450CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]73 package rows20111103_8a023942-01e8-4849-aa3c-1a640ffc7fd3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AceclofenacACTIVE INGREDIENTRPK779R03HCLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
AceclofenacACTIVE MOIETYRPK779R03HCLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
AlcoholINACTIVE INGREDIENT3K9958V90MCLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Carbomer 941INACTIVE INGREDIENTF68VH75CJCCLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UCLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Colloidal Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
CrospovidoneINACTIVE INGREDIENT68401960MKCLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Diethyl PhthalateINACTIVE INGREDIENTUF064M00AFCLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
EthylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BCLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Hypromellose 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Hypromellose 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Hypromellose 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XCLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Magnesium StearateINACTIVE INGREDIENT70097M6I30CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Methylene ChlorideINACTIVE INGREDIENT588X2YUY0ACLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Poloxamer 407INACTIVE INGREDIENTTUF2IVW3M2CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Sodium CarbonateINACTIVE INGREDIENT45P3261C7TCLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPCLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]7

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 239 of 271 · 5,408 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOOTHE Daily Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERodan & Fields9acbf663-15e4-4572-a267-56afa58a347b2023-11-30WarningsExact identifier
unii: 15FIX9V2JP
Coconut Scented Hand SanitizerALCOHOLFOURSTAR GROUP USA, INC.95d41ada-68fc-44bf-bf34-1904d5b0dc452023-11-29WarningsExact identifier
unii: 3K9958V90M
Natural Extensions Fragrance- Free Instant Hand SanitizerALCOHOLBenco Dentalb1f10f16-8269-402a-9646-32dbfdef1ffc2023-11-28WarningsExact identifier
unii: 3K9958V90M
Zogics Instant Hand Sanitizer Hydrating GelALCOHOLZogics, LLC29c5f277-7b8a-4f38-8a09-33139f27c9102023-11-28WarningsExact identifier
unii: 3K9958V90M
Alcohol WipesALCOHOLShaoxing Elite Bio-Tech Co.,Ltd.b42c2735-ead2-4db9-e053-2a95a90a229f2023-11-22WarningsExact identifier
unii: 3K9958V90M
AntiBacterialHandSpray Vampire BloodALCOHOLBath & Body Works, Inc.0aac0b96-e477-173c-e063-6294a90a9a162023-11-21WarningsExact identifier
unii: 3K9958V90M
B-Pure Coconut Scented Hand SanitizingALCOHOLFourstar Group USA, Inc.52b21789-d544-451e-b54a-4e2b4b85f4452023-11-21WarningsExact identifier
unii: 3K9958V90M
B-Pure Lavender Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.c82c37d7-d8fd-4411-a18f-fab4d1eaa2a92023-11-21WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLHit Promotional Productsa410e8a6-5c68-4358-a6ce-77d7a99ace792023-11-21WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLZhejiang Ayan Biotech Co.,Ltd.125fdc7c-fea3-4ced-8df2-0d35877df62d2023-11-21WarningsExact identifier
unii: 3K9958V90M
SPF 60 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDerma Care Research Labs, LLC0aae69f1-66bf-a199-e063-6394a90a3d752023-11-21WarningsExact identifier
unii: 15FIX9V2JP
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDERite Aid0a9c1b3f-656d-0d62-e063-6394a90a47312023-11-20WarningsExact identifier
unii: 15FIX9V2JP
Cetaphil Sheer Mineral Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.581e8289-1406-45b6-9786-753800665fad2023-11-20WarningsExact identifier
unii: 15FIX9V2JP
TerrestristatALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), CEREBRUM SUIS, PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, COFFEA CRUDA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, RADIUM BROMATUM, CARCINOSIN, TARENTULA CUBENSIS, X-RAY, HOLMIUM METALLICUM, URANIUM NITRICUM.Energique, Inc.9bd83312-6872-4e39-b7ff-bbeb69015d802023-11-17WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 45P3261C7T
AntiBacterialHandSpray Chasing FirefliesALCOHOLBath & Body Works, Inc.0a4a013d-b8bb-bd70-e063-6394a90aa9682023-11-16WarningsExact identifier
unii: 3K9958V90M
AntiBacterialHandSpray Twisted PeppermintALCOHOLBath & Body Works, Inc.0a4a94e7-0310-df2c-e063-6394a90aff1a2023-11-16WarningsExact identifier
unii: 3K9958V90M
AntiBacterialHandSpray Warm Vanilla SugarALCOHOLBath & Body Works, Inc.0a4a971d-6fd7-6cfb-e063-6294a90a678b2023-11-16WarningsExact identifier
unii: 3K9958V90M
AntiBacterialHandSpray Winter Candy AppleALCOHOLBath & Body Works, Inc.0a4abed5-8b48-019b-e063-6394a90a42472023-11-16WarningsExact identifier
unii: 3K9958V90M
AntiBacterialHandSpray Sweater WeatherALCOHOLBath & Body Works, Inc.0a4a971d-6fd0-6cfb-e063-6294a90a678b2023-11-16WarningsExact identifier
unii: 3K9958V90M
AntiBacterialHandSpray Purrfect PumpkinALCOHOLBath & Body Works, Inc.0a4acfb6-75cd-0632-e063-6394a90af27b2023-11-16WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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