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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65697-450-20	2019-11-13	C162847	48780-1	97449f38-bb73-f6ea-e053-dbdaa90aa703	8a023942-01e8-4849-aa3c-1a640ffc7fd3
65697-450-22	2019-11-13	C162847	48780-1	97449f38-bb73-f6ea-e053-dbdaa90aa703	8a023942-01e8-4849-aa3c-1a640ffc7fd3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65697-450-20	ClanzaCR	1 in 1 PACKET	TABLET, FILM COATED	1	7
65697-450-21	ClanzaCR	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	7
65697-450-22	ClanzaCR	10 in 1 CARTON	TABLET, FILM COATED	10	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65697-450	CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]	7	3 package rows	20111103_8a023942-01e8-4849-aa3c-1a640ffc7fd3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Aceclofenac	ACTIVE INGREDIENT	RPK779R03H	CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]	7
Aceclofenac	ACTIVE MOIETY	RPK779R03H	CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]	7
Alcohol	INACTIVE INGREDIENT	3K9958V90M	CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]	7
Carbomer 941	INACTIVE INGREDIENT	F68VH75CJC	CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]	7
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]	7
Colloidal Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]	7
Crospovidone	INACTIVE INGREDIENT	68401960MK	CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]	7
Diethyl Phthalate	INACTIVE INGREDIENT	UF064M00AF	CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]	7
Ethylcelluloses	INACTIVE INGREDIENT	7Z8S9VYZ4B	CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]	7
Hypromellose 2208 (15000 MPA.S)	INACTIVE INGREDIENT	Z78RG6M2N2	CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]	7
Hypromellose 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]	7
Hypromellose 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]	7
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]	7
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]	7
Methylene Chloride	INACTIVE INGREDIENT	588X2YUY0A	CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]	7
Poloxamer 407	INACTIVE INGREDIENT	TUF2IVW3M2	CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]	7
Sodium Carbonate	INACTIVE INGREDIENT	45P3261C7T	CLANZA CR (ACECLOFENAC) TABLET, FILM COATED [UNITED DOUGLAS PHARM., INC.]	7
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CLANZA 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 255 of 269 · 5,363 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bareMinerals Original Foundation Broad Spectrum SPF 15 Fair Ivory	TITANIUM DIOXIDE	Orveon Global US LLC	15c92bce-75f4-40e3-ae28-9bcbc241c8e9	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Complexion Rescue Defense Radiant Protective Veil Broad Spectrum SPF 30 Soft Radiance	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	0c2db44d-8604-4883-ab01-f14bc441e4e4	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Beige 12	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	3c35fd13-1a4b-4acf-ada4-16ee2e52dd94	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Prime Time BB Primer-Cream Broad Spectrum SPF 30 Medium	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	3cc5b952-4619-4395-97c0-5b68efa9af6d	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Skinlongevity Vital Power Moisturizer Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	29c25bc3-902a-41af-996a-8c7e8a4bf574	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Fairly Light 03	TITANIUM DIOXIDE	Orveon Global US LLC	b2909888-5a98-4894-a895-230aa53f64d9	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Tan 19	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	a5888955-f381-4209-9589-bd2e79a84f59	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Light 08	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	ad15bdee-67e6-4281-8144-e84b7c478a34	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Tan 18	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	aa4d7945-6cc9-4f20-b588-a5588e57d30a	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Tan 20	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	2f8b6c57-dcae-408e-898d-d5630deeb090	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Fair 04	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	e486915b-8097-451a-a018-3279213239b3	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Deep 28	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	5b51df09-40c3-4064-96d3-b7366fc83826	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Fairly Medium 05	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	f1714e23-030c-4bd9-b9e7-111c3813ed34	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Dark 23	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	828fe263-f223-45c3-9710-fd8d59ad56b1	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
bareMinerals Multi-Tasking SPF 20 Concealer Bisque	TITANIUM DIOXIDE	Orveon Global US LLC	d4c30bea-8c56-4ed8-8ec4-f1b1e0e456dd	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
BareMinerals Mineral Veil	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	64b163dd-8a86-483f-8dab-80fa8740b12f	2023-10-04	Warnings	Exact identifier unii: 15FIX9V2JP
Hand sanitizer 1.8oz with extra clip original	ETHYL ALCOHOL	Rejoice International Corp.	06da0cc1-95f2-4f88-e063-6394a90a25ea	2023-10-03	Warnings	Exact identifier unii: 3K9958V90M
BHI Migraine	ACETIC ACID, ARANEUS DIADEMATUS, ASAFETIDA, BRYONIA ALBA WHOLE, TRIBASIC CALCIUM PHOSPHATE, ACTIVATED CHARCOAL, CINCHONA OFFICINALIS BARK, MARSDENIA CONDURANGO BARK, TUBOCURARINE CHLORIDE, KALMIA LATIFOLIA LEAF, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, PHOSPHORIC ACID, PULSATILLA VULGARIS, CLAVICEPS PURPUREA SCLEROTIUM, AND SILICON DIOXIDE	MediNatura Inc	11cad8ba-6914-420e-bab0-4ca37d33f2e6	2023-09-28	Warnings	Exact identifier unii: ETJ7Z6XBU4
Zeel	ALPHA LIPOIC ACID, ARNICA MONTANA WHOLE,SUS SCROFA CARTILAGE, COENZYME A,SOLANUM DULCAMARA TOP,SUS SCROFA EMBRYO,SUS SCROFA UMBILICAL CORD, NADIDE, SODIUM DIETHYL OXALACETATE,SUS SCROFA PLACENTA,TOXICODENDRON PUBESCENS LEAF, SANGUINARIA CANADENSIS ROOT, SILICON DIOXIDE,SULFUR,CORIANDER	Biologische Heilmittel Heel	d5d7a2e5-a6ce-4a41-9430-1378023aa7d0	2023-09-28	Warnings	Exact identifier unii: ETJ7Z6XBU4
Hand Sanitizing Wipes	HAND SANITIZING WIPES	Innovative Biodefense	b01d3c2c-056c-314c-e053-2a95a90a42f4	2023-09-16	Warnings	Exact identifier unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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