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 200 of 271 · 5,408 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aquabain Instant Hand Sanitizer	ETHYL ALCOHOL 70%	Industria La Popular, S.A.	b2e4d58d-adff-3cb2-e053-2995a90a392e	2024-12-02	Warnings	Exact identifier unii: 3K9958V90M
Anti Bacterial Hand Gel Vanilla Noir	ALCOHOL	Bath & Body Works, Inc.	284ee56f-36e1-c5f9-e063-6294a90a6251	2024-12-02	Warnings	Exact identifier unii: 3K9958V90M
Geovita	CEREBRUM, CUPRUM MET, FERRUM MET, FORMICUM ACIDUM, SILICEA	RUBIMED AG	0fcb5c06-d414-456c-a0ef-28e14018a781	2024-11-29	Warnings	Exact identifier unii: ETJ7Z6XBU4
Para-Si	JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER	Newton Laboratories, Inc.	27d41602-9dcb-eaa8-e063-6394a90a7cfa	2024-11-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
Para-Si	JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHEIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER	Newton Laboratories, Inc.	27d4ddaf-9c07-a7fc-e063-6394a90adc0b	2024-11-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
Para-Si	JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER	Newton Laboratories, Inc.	27d5997b-1cae-41c2-e063-6394a90ac74a	2024-11-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
Servo Stat-Foam	ALCOHOL	Enzyme Solutions, Inc.	a4535b70-04cb-4227-81d3-4dd55086ba7a	2024-11-26	Warnings	Exact identifier unii: 3K9958V90M
Servo-Stat	ALCOHOL	Enzyme Solutions, Inc.	70562cae-b316-4033-b457-40ba71f6881c	2024-11-26	Warnings	Exact identifier unii: 3K9958V90M
First Aid Only Instant Hand Sanitizer	ALCOHOL	Acme United Corporation	c94e8db3-2db7-fce4-e053-2a95a90a62d9	2024-11-26	Warnings	Exact identifier unii: 3K9958V90M
Fresh Nap Plus Hand Sanitizer	ETHYL ALCOHOL	Acme United Corporation	fdc8aca2-aec5-0832-e053-6394a90a6140	2024-11-26	Warnings	Exact identifier unii: 3K9958V90M
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 9N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	95d657e5-cf89-48dd-a12e-f9664b131eb9	2024-11-25	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	33f42840-92f8-4fa1-86e9-ec0a06d637de	2024-11-25	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	20785934-e534-4ea5-8c15-f9669b042153	2024-11-25	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	e4464601-a9ec-413b-a883-9efe61f2f5b2	2024-11-25	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 8N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5e7c879c-1e5c-4614-bec1-d363978c3b0d	2024-11-25	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5c1f1f09-19fb-4ceb-bb6d-22d51b5733a8	2024-11-25	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c8a48759-efac-47ac-972a-c994b6774e20	2024-11-25	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	793c18e5-4363-45b0-a184-0b6c69a91b2c	2024-11-25	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	8a542b3c-c3c0-465a-9b24-6a62016656f3	2024-11-25	Warnings	Exact identifier unii: 15FIX9V2JP
Instant Antiseptic Hand Sanitizer	ALCOHOL	United Laboratories Inc.	f91a5ac5-0f78-4cf5-be57-6562714791cd	2024-11-25	Warnings	Exact identifier unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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