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 235 of 271 · 5,408 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ethyl Rubbing Alcohol	ALCOHOL	Humco Holding Group, Inc.	829f3e16-7a9b-4da7-87d2-f58254bda721	2023-12-15	Warnings	Exact identifier unii: 3K9958V90M
Humco Iodides Tincture	ETHYL ALCOHOL	Humco Holding Group, Inc.	d230e3a2-1cde-44a9-82c3-3dc5474b3a72	2023-12-15	Warnings	Exact identifier unii: 3K9958V90M
Rite Aid Decolorized Iodine	ETHYL ALCOHOL	Rite Aid Corporation	5e0d3664-b02a-ba28-e053-2991aa0a8a4c	2023-12-15	Warnings	Exact identifier unii: 3K9958V90M
De La Cruz Tincture of Iodine	IODINE AND SODIUM IODIDE AND ALCOHOL	DLC Laboratories, Inc.	5d8f60a9-6d1c-0b0f-e053-2991aa0a8a9b	2023-12-15	Warnings	Exact identifier unii: 3K9958V90M
ERBORIAN - BB CREME NUDE SPF20	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	337a771e-c965-421a-a8e7-d853ffe51c2c	2023-12-15	Warnings	Exact identifier unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium	TITANIUM DIOXIDE AND ZINC OXIDE	Cosmetique Active Production	b4cef09a-f0e4-4054-a200-667df7d150bf	2023-12-15	Warnings	Exact identifier unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	1f3b56d5-c33a-401f-8c8a-924345a4846e	2023-12-15	Warnings	Exact identifier unii: 15FIX9V2JP
ALCOHOL ANTISEPTIC HAND SANITIZER ANTIBACTERIAL	ALCOHOL	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	0c73f4f5-2b1d-84ae-e063-6394a90a5d7b	2023-12-14	Warnings	Exact identifier unii: 3K9958V90M
Rejuvity moisturizing day cream BROAD SPECTRUM SPF 15 SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	Isagenix International, LLC	6d2d5590-5f53-48d9-94c5-fe9f6a5cf3ce	2023-12-14	Warnings	Exact identifier unii: 15FIX9V2JP
GNP Idoinde Tincture 2% Mild	IODINE AND SODIUM IODIDE AND ALCOHOL	Amerisource Bergen	32ad75b8-abd1-4151-a035-b6c9ae5fc888	2023-12-14	Warnings	Exact identifier unii: 3K9958V90M
bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Fair 01	TITANIUM DIOXIDE	Orveon Global US LLC	29738578-6681-476e-8660-7219f58e8fa0	2023-12-13	Warnings	Exact identifier unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Cosmetique Active Production	4e56f3f2-b856-4bbc-ab39-6fb5887a4846	2023-12-13	Warnings	Exact identifier unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	2ce83dc2-84b6-43fd-8b11-495d41cebc22	2023-12-13	Warnings	Exact identifier unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE	Cosmetique Active Production	4d5d1e79-7b3e-41b5-ae6b-a3b0265702ca	2023-12-13	Warnings	Exact identifier unii: 15FIX9V2JP
Antibacterial Hand Sanitizer	ALCOHOL	Prostock LLC.	a184c473-6fa8-f09b-e053-2a95a90a1b17	2023-12-12	Warnings	Exact identifier unii: 3K9958V90M
AntiochPharma Rapidgel Hand Sanitizer	ALCOHOL	Weeks & Leo	0c57a9ea-de66-3ced-e063-6294a90a4b8d	2023-12-12	Warnings	Exact identifier unii: 3K9958V90M
RODAN FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30	TITANIUM DIOXIDE	Rodan & Fields	1a936053-2be0-4c52-a073-ba846b87f811	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Broad Spectrum SPF 30 Up The Anti	TITANIUM DIOXIDE, ZINC OXIDE	Biopelle, Inc.	37506766-370e-4ae4-8dbe-915a763e7c55	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Youth Activating BB SPF30 Shade 3	ZINC OXIDE, TITANIUM DIOXIDE	Englewood Lab, Inc.	c84207c4-a779-4c00-a486-86eaf8ece169	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
MD Mineral BB Creme Broad Spectrum SPF 50 Water Resistant 80 Min	TITANIUM DIOXIDE, ZINC OXIDE	ENGLEWOOD LAB, INC.	5742da4b-6713-4de9-8ab8-b2bf2983371a	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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