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 164 of 272 · 5,426 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterillium MedALCOHOLBODE Chemie GmbH8d80d5fd-7869-c551-e053-2995a90af2a92025-04-30WarningsExact identifier
unii: 3K9958V90M
Sterillium ComfortALCOHOLBODE Chemie GmbH8efc9f4e-3b20-60ba-e053-2995a90af8b12025-04-30WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST BLUE RASPBERRY SCENTETHYL ALCOHOLPearl World Inc.106955cd-4485-4a0b-87a2-d4343e6a89f62025-04-29WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST GUMMY BEAR SCENTETHYL ALCOHOLPearl World Inc.f8e02860-0e21-4e5c-b2fc-1340d145afe02025-04-29WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST BUBBLE TEA SCENTETHYL ALCOHOLPearl World Inc.f0fbe51f-3402-42a1-8364-8e3f2e35ee662025-04-29WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST MANGO SCENTETHYL ALCOHOLPearl World Inc.33123052-f8e6-433d-9734-05e21ecc0e622025-04-29WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PEAR SPLASH SCENTETHYL ALCOHOLPearl World Inc.20f9d364-9386-4d60-9c60-13c5819588602025-04-29WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST CHERRY SCENTETHYL ALCOHOLPearl World Inc.6e2c5527-b18a-46af-91b9-e9aa7d1498362025-04-29WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST OCEAN BREEZE SCENTETHYL ALCOHOLPearl World Inc.00a0af9f-76ce-440d-b25e-2bb40c88fd1d2025-04-29WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST SWEET PEONY SCENTETHYL ALCOHOLPearl World Inc.aeca3043-7f90-43e8-9890-d20a9727b95b2025-04-29WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST VANILLA SUGAR SCENTETHYL ALCOHOLPearl World Inc.740d4fd7-c4c3-448b-ad1e-6227b9f2d5252025-04-29WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST COCONUT LIME SCENTETHYL ALCOHOLPearl World Inc.9ef8a421-633a-4615-ae1d-dbd2568d947b2025-04-29WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST STRAWBERRY SCENTETHYL ALCOHOLPearl World Inc.673ea52e-0033-4831-8656-7392cf7b7c712025-04-29WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PEACH SCENTETHYL ALCOHOLPearl World Inc.7b263fac-38b4-4bdf-9ac3-419ddb2fc37a2025-04-29WarningsExact identifier
unii: 3K9958V90M
SANSPRAYANTIBACTERIAL SANITIZER SPRAYBeacon Promotions Inc0e243179-37f6-45dc-e063-6394a90a5f802025-04-28WarningsExact identifier
unii: 3K9958V90M
Sanell Hand SanitizerALCOHOLOraLabs0a6cc2a8-f568-45ae-8d82-a70103c774c72025-04-28WarningsExact identifier
unii: 3K9958V90M
Sanell Hand SanitizerALCOHOLOraLabs7184b9ad-0125-413d-b054-f46239b8ca922025-04-28WarningsExact identifier
unii: 3K9958V90M
Pink Pineapple SCENTED HAND SANITIZERALCOHOLMELON BIO-TECH (THAILAND) CO., LTD.73543eed-e022-4d51-b606-000dcc0232982025-04-28WarningsExact identifier
unii: 3K9958V90M
Vanilla Sugar SCENTED HAND SANITIZERALCOHOLMELON BIO-TECH (THAILAND) CO., LTD.6c790c49-7b4a-4e07-b5ce-9a31db84e01f2025-04-28WarningsExact identifier
unii: 3K9958V90M
Strawberry Pound Cake SCENTED HAND SANITIZERALCOHOLMELON BIO-TECH (THAILAND) CO., LTD.34750790-4eec-4a2d-9686-2c69c1db79e62025-04-28WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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