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 268 of 269 · 5,363 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alcohol Wipes	ALCOHOL	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	14dbe9dc-2504-4181-9565-5fa7c1a9c377	2017-10-09	Warnings	Exact identifier unii: 3K9958V90M
Freeman Packaging Hand Sanitizer	ALCOHOL	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	9827418a-3ab6-447b-8f8a-9eacb56d3a89	2017-10-09	Warnings	Exact identifier unii: 3K9958V90M
ONID Wipe	ETHANOL	ONID Technology Corp	83d8b8b6-6257-4553-9441-901bb02c3d60	2017-06-28		Exact identifier unii: 3K9958V90M
Teething-HP	BORAX, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, PASSIFLORA INCARNATA, PODOPHYLLINUM, SILICEA	BioActive Nutritional, Inc.	1758624d-7ed8-49a6-ab24-2aab57703c91	2017-06-16	Warnings	Exact identifier unii: ETJ7Z6XBU4
Parathyroplex	PARATHYROID GLAND (BOVINE), BARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CUPRUM METALLICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, RHUS TOX, SILICEA	BioActive Nutritional, Inc.	37649bb9-cbd7-4971-b410-18ea307c46f6	2017-04-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
Age Renewal Firming and Hydrating Moisturizer SPF 30	OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE	CVS Health	5f6f677d-2404-4e56-a48f-4263314afd9b	2017-03-14	Warnings	Exact identifier unii: 15FIX9V2JP
Your Name Cosmetics Brightening CC Cream Broad Spectrum SPF 20	YOUR NAME COSMETICS BRIGHTENING CC CREAM BROAD SPECTRUM SPF 20	Mana Products	ae6a86d2-a95b-4fa8-9676-233ef9fdc3b0	2017-02-22	Warnings	Exact identifier unii: 15FIX9V2JP
ReHydration	ADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, NATRUM MURIATICUM, SARSAPARILLA, SILICEA, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)	Energetix Corp	9883c502-9782-451e-9eec-c54d7b054f31	2017-01-31	Warnings	Exact identifier unii: ETJ7Z6XBU4
Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 Sunscreen	NUANCE SALMA HAYEK RENEWED RADIANCE BRIGHTENING BB CREAM BROAD SPECTRUM SPF 30 SUNSCREEN	CVS Pharmacy, Inc	7795e651-838e-41f8-b48d-bd2e0dd1beec	2017-01-18	Warnings	Exact identifier unii: 15FIX9V2JP
DERMAdoctor DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30	DERMADOCTOR DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30	Mana Products	cec89a7e-1670-4d3c-b48c-28ed1ea7f957	2016-12-07	Warnings	Exact identifier unii: 15FIX9V2JP
Tox-Chord	ALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUM	Energetix Corp	6b0d1628-b20d-426e-9c84-5cceadca3f45	2016-11-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
Age Renewal Firming	OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE	AMCOL Health & Beauty Solutions, Inc. DBA	6cb27f87-40a3-4049-aded-eb788509c575	2016-10-07	Warnings	Exact identifier unii: 15FIX9V2JP
Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 Sunscreen	NUANCE SALMA HAYEK RENEWED RADIANCE BRIGHTENING BB CREAM BROAD SPECTRUM SPF 30 SUNSCREEN	Mana Products	d0e00d97-dbf4-46af-aeda-bdfd6f49b5ab	2016-09-08	Warnings	Exact identifier unii: 15FIX9V2JP
Thyrotox	CHONDRUS CRISPUS, FUCUS VESICULOSUS, THYROIDINUM, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, IODIUM, KALI CARBONICUM, PHOSPHORUS, PULSATILLA (VULGARIS), SILICEA	BioActive Nutritional, Inc.	e229a260-13f3-4136-b325-9a8954f8a327	2016-08-10	Warnings	Exact identifier unii: ETJ7Z6XBU4
Teething	ARNICA MONTANA, TRIFOLIUM PRATENSE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CHAMOMILLA, KREOSOTUM, SILICEA	BioActive Nutritional, Inc.	f39c9feb-f567-43a2-a026-2a581aeeed9d	2016-07-27	Warnings	Exact identifier unii: ETJ7Z6XBU4
Meijer Kids Tear Free SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Meijer Distribution, Inc.	7415511e-1ecf-4646-b64b-267fbf7d116b	2016-06-02	Warnings	Exact identifier unii: 15FIX9V2JP
Meijer Baby Tear Free SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Meijer Distributing Inc.	2434de23-bcc9-4a83-9945-16fc3f2b8c61	2016-06-01	Warnings	Exact identifier unii: 15FIX9V2JP
TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted)	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE AND ZINC OXIDE	Allergan, Inc.	6a996e03-907f-4e6a-b232-0892b86956b0	2015-08-21	Warnings	Exact identifier unii: 15FIX9V2JP
CVS Hand Sanitizer	ALCOHOL	CVS	d0081c50-c0d2-436a-ba83-5d1982ae64b7	2015-08-17	Warnings	Exact identifier unii: 3K9958V90M
Renewal Firming Day Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	BURT'S BEES, INC.	18ceb5d8-4b76-6a54-e054-00144ff88e88	2015-06-18	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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