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 214 of 271 · 5,408 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6.5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	05f7119a-0c92-4393-a62d-8e84ec451d20	2024-08-07	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b90ee1ba-17b5-4367-9df3-e9e27217960c	2024-08-07	Warnings	Exact identifier unii: 15FIX9V2JP
DermaCen Lotionized Hand Sanitizer	ALCOHOL	Central Solutions Inc	1f1e6c95-533f-d3e4-e063-6394a90a0560	2024-08-07	Warnings	Exact identifier unii: 3K9958V90M
Smart Care LEMON LIME HAND SANITIZER	ETHYL ALCOHOL	Ashtel Studios Inc.	f021873f-b25c-433a-9d82-2bf9b10e6f8a	2024-08-07	Warnings	Exact identifier unii: 3K9958V90M
Smart Care WATERMELON HAND SANITIZER	ETHYL ALCOHOL	Ashtel Studios Inc.	dc2c772b-4bd4-4a5f-b89d-ad2ca36574e0	2024-08-07	Warnings	Exact identifier unii: 3K9958V90M
Sugar Cookie Sanitizer 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	1efc0e9e-b4eb-d2b0-e063-6394a90a7779	2024-08-06	Warnings	Exact identifier unii: 3K9958V90M
Lemon Lime Hand Sanitizer Spray. 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	1efe7236-d7bd-2a1c-e063-6294a90a736e	2024-08-06	Warnings	Exact identifier unii: 3K9958V90M
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	ad5c5121-d75d-449d-a4db-a7b074787f68	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 00	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	0018573d-922b-4642-9513-63481e9131d5	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	83b20b0d-c2db-4720-8434-57b73847ebca	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	105651f2-3c99-4ff3-b67b-350a40dc8888	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	7b1b551b-e78d-47ff-bb91-0d5f676c73fc	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	2411e8e6-a958-4fd9-b5e9-b9a32020ce54	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	062f61d2-a9a7-46e1-92e4-a6bdf257c188	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	9c3d513f-8331-4155-a77b-c358093a607c	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b7f8d1d0-1734-46a5-82fe-b0ac14017522	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3C	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c3849d5c-4f91-4147-aeb2-7461a3a94309	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4C	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	e8f29488-10f8-4df6-b1f5-d9a670f60fca	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	86e0d1e4-3207-49e6-b5fa-e63f4ca300db	2024-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
SANTO REMEDIOS RADIANCE SILKY MINERAL PRIMER SUNSCREEN SPF 42 IVORY	TITANIUM DIOXIDE, ZINC OXIDE	SANTO REMEDIO LLC	0708ec87-16c4-412b-971b-d4572931c780	2024-08-05	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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