NDC 60505-0065-01 - Omeprazole

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: 60505-0065
Requested NDC: 60505-0065-01
Package NDCs from labels: 60505-0065-0, 60505-0065-2, 60505-0065-5, 60505-0065-1, 60505-0065-8, 60505-0065-3, 60505-0065-7, 60505-0065-01
Manufacturer: Bryant Ranch Prepack
Effective date: 2024-10-31
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Omeprazole - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-10-31	HUMAN PRESCRIPTION DRUG LABEL
Omeprazole - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-10-03	HUMAN PRESCRIPTION DRUG LABEL
Omeprazole - Proficient Rx LP	Proficient Rx LP	2024-10-01	HUMAN PRESCRIPTION DRUG LABEL
Omeprazole - Apotex Corp \| Apotex Inc.	Apotex Corp \| Apotex Inc.	2024-04-22	HUMAN PRESCRIPTION DRUG LABEL
OMEPRAZOLE DR - Direct Rx	Direct Rx	2023-05-31	HUMAN PRESCRIPTION DRUG LABEL
Omeprazole - AvKARE	AvKARE	2022-01-13	HUMAN PRESCRIPTION DRUG LABEL
Omeprazole - PD-Rx Pharmaceuticals, Inc.	PD-Rx Pharmaceuticals, Inc.	2021-07-28	HUMAN PRESCRIPTION DRUG LABEL
Omeprazole - QPharma Inc \| Apotex Inc. \| Denton Pharma, Inc. DBA Northwind Pharmaceuticals	QPharma Inc \| Apotex Inc. \| Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-03-04	HUMAN PRESCRIPTION DRUG LABEL
Omeprazole - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL
Omeprazole - REMEDYREPACK INC.	REMEDYREPACK INC.	2019-11-20	HUMAN PRESCRIPTION DRUG LABEL
Omeprazole - Major Pharmaceuticals	Major Pharmaceuticals	2019-10-22	HUMAN PRESCRIPTION DRUG LABEL
Omeprazole - Preferred Pharmaceuticals, Inc.	Preferred Pharmaceuticals, Inc.	2019-02-06	HUMAN PRESCRIPTION DRUG LABEL
Omeprazole - St. Mary's Medical Park Pharmacy \| Legacy Packaging \| Apotex Inc.	St. Mary's Medical Park Pharmacy \| Legacy Packaging \| Apotex Inc.	2018-11-16	HUMAN PRESCRIPTION DRUG LABEL
Omeprazole - Contract Pharmacy Services-PA \| Coupler Enterprises	Contract Pharmacy Services-PA \| Coupler Enterprises	2017-09-19	HUMAN PRESCRIPTION DRUG LABEL
Omeprazole - Unit Dose Services	Unit Dose Services	2017-07-01	HUMAN PRESCRIPTION DRUG LABEL
Omeprazole - NuCare Pharmaceuticals, Inc.	NuCare Pharmaceuticals, Inc.	2017-05-22	HUMAN PRESCRIPTION DRUG LABEL
Omeprazole Delayed-Release - DOH CENTRAL PHARMACY	DOH CENTRAL PHARMACY	2017-02-03	HUMAN PRESCRIPTION DRUG LABEL
PrevidolRx Analgesic Pak - GenPak Solutions, LLC	GenPak Solutions, LLC	2016-01-26	HUMAN PRESCRIPTION DRUG LABEL
OMEPRAZOLE DR - Northwind Pharmaceuticals, LLC	Northwind Pharmaceuticals, LLC	2015-06-09	HUMAN PRESCRIPTION DRUG LABEL
Omeprazole - Blenheim Pharmacal, Inc.	Blenheim Pharmacal, Inc.	2015-04-10	HUMAN PRESCRIPTION DRUG LABEL
Omeprazole - Blenheim Pharmacal, Inc. \| Blenheim Pharmacal, Inc	Blenheim Pharmacal, Inc. \| Blenheim Pharmacal, Inc	2015-03-19	HUMAN PRESCRIPTION DRUG LABEL
Omeprazole - Carilion Materials Management	Carilion Materials Management	2015-01-16	HUMAN PRESCRIPTION DRUG LABEL
Omeprazole - RxChange Co.	RxChange Co.	2014-11-14	HUMAN PRESCRIPTION DRUG LABEL
Omeprazole - Safecor Health, LLC	Safecor Health, LLC	2014-05-20	HUMAN PRESCRIPTION DRUG LABEL
Omeprazole - H.J. Harkins Company, Inc. \| Apotex Inc.	H.J. Harkins Company, Inc. \| Apotex Inc.	2012-04-23	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60505-0065-0	Omeprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	35
60505-0065-1	Omeprazole	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	35
60505-0065-2	Omeprazole	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	35
60505-0065-3	Omeprazole	10 in 1 BLISTER PACK	CAPSULE, DELAYED RELEASE	10	35
60505-0065-3	Omeprazole	7 in 1 CARTON	CAPSULE, DELAYED RELEASE	7	35
60505-0065-5	Omeprazole	500 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	500	35
60505-0065-7	Omeprazole	10 in 1 BLISTER PACK	CAPSULE, DELAYED RELEASE	10	35
60505-0065-7	Omeprazole	10 in 1 CARTON	CAPSULE, DELAYED RELEASE	10	35
60505-0065-8	Omeprazole	5000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	5000	35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-0065	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	35	Current NDC, Legacy NDC, 9 package rows	20240423_b83329ac-a65e-b3af-a3fb-c5a6c740e5e7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-0065-0	EA - Each	60505-0065	a0b93b90-aa3b-427b-9732-d7adddf30122	1	2012-07-24
60505-0065-1	EA - Each	60505-0065	a3c4a345-ef94-419e-b9d2-759731316d0d	1	2012-07-24
60505-0065-2	EA - Each	60505-0065	1a7475d8-47a9-41ef-86e9-3801139e81e1	1	2012-07-24
60505-0065-7	EA - Each	60505-0065	360584cc-f4ca-4b44-9ffe-370b1974494a	1	2012-07-24
60505-0065-8	EA - Each	60505-0065	edf88be9-edfa-48bb-977f-602d1475398a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Omeprazole	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
Omeprazole	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
Omeprazole	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	9
Omeprazole	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	9
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	9
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	9
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	9
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	9
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	9
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	9
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	9
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	9
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	9
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	9
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	9
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	9
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	9
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	9
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	9
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
Omeprazole	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STAT RX USA LLC]	3
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
Omeprazole	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STAT RX USA LLC]	3
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STAT RX USA LLC]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STAT RX USA LLC]	3
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STAT RX USA LLC]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
DIBUTYL SEBACATE	INACTIVE INGREDIENT	4W5IH7FLNY	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STAT RX USA LLC]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STAT RX USA LLC]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STAT RX USA LLC]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STAT RX USA LLC]	3
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STAT RX USA LLC]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STAT RX USA LLC]	3
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
OLEIC ACID	INACTIVE INGREDIENT	2UMI9U37CP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STAT RX USA LLC]	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STAT RX USA LLC]	3
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STAT RX USA LLC]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STAT RX USA LLC]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STAT RX USA LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [STAT RX USA LLC]	3
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	3
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]	2
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	2
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SAFECOR HEALTH, LLC]	2
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]	2
Omeprazole	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SAFECOR HEALTH, LLC]	2
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SAFECOR HEALTH, LLC]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SAFECOR HEALTH, LLC]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SAFECOR HEALTH, LLC]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SAFECOR HEALTH, LLC]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [SAFECOR HEALTH, LLC]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2

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 2 of 397 · 7,927 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin E	LIP BALM SPF25	Jack Black, LLC	88e8752d-1fbf-4e28-b79d-7c05ecdce842	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Jack Black Intense Lip Therapy SPF25, Natural Mint and Shea Butter	LIP BALM SUNSCREEN	Jack Black, LLC	e8730127-2d8d-4b80-ab90-d2f136d9e516	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Jack Black Intense Therapy Lip Balm SPF25, Grapefruit and Ginger	LIP BALM SUNSCREEN	Jack Black, LLC	d961d22a-2125-41e9-94a3-5b53d12b320f	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Jack Black Intense Lip Therapy SPF25, Black Tea and Blackberry	LIP BALM SUNSCREEN	Jack Black, LLC	172a70bc-8a09-4258-b9bf-cf3c67ff7613	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Intense Therapy Lip Balm Asian Pear	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	acace707-6671-4818-86f2-d9813792157a	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Intense Therapy Lip Balm Basil Lemon	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	277cb44d-608a-4ffc-a2a5-ac57d33d214c	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Intense Therapy Lip Balm Black Cherry	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	8f413bd6-258c-4c3c-89d1-369938c85720	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Intense Therapy Lip Balm Cucumber Lime	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	5f15bee9-9bf4-4f27-a6b5-4205deb625f6	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Intense Therapy Lip Balm Winter Melon	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	e7792b4e-a6d2-487e-ba28-27b68e6d7e27	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Jack Black Intense Therapy Lip Balm Vanilla Bourbon	AVOBENZONE, OCTINOXATE LIP BALM SUNSCREEN	Jack Black, LLC	517040d1-e6ed-40ca-a46f-2f75403dbc3c	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Intense Therapy Lip Balm Mango and Mandarin	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	8c55d1cd-cdd6-468b-8a17-b940c6210116	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Jack Black Intensive Therapy Lip Balm Mango Chili Lime	AVOBENZONE, OCTINOXATE LIP BALM SUNSCREEN	Jack Black, LLC	51349d57-b14d-4798-8d68-03fbe3713d1e	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Jack Black Intense Thearpy Lip Balm SPF25, Lemon and Shea Butter	LIP BALM SUNSCREEN	Jack Black, LLC	518cb17a-fdaa-4a60-93fc-708305366eb8	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Jack Black Lavender Lip Balm 0.25oz	LIP BALM SUNSCREEN	Jack Black, L.L.C.	e8c6a6d9-1093-41f1-87d5-faf8583d4319	2026-09-08	Warnings	Exact identifier unii: 4T6H12BN9U
Sting Relief Pad	BENZOCAINE, ISOPROPYL ALCOHOL CLOTH	JINHUA JINGDI MEDICAL SUPPLIES CO., LTD	57ccc28b-5f5f-30ec-e063-6294a90a081c	2026-09-07	Warnings	Exact identifier unii: ND2M416302
hand sanitizer - cherry sundae	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	270d2ce0-6310-4a84-be8a-72db6062bae7	2026-09-07	Warnings	Exact identifier unii: 3K9958V90M
hand sanitizer - vanilla frosting	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	f6cabda2-6e1c-4238-9a2e-df10e263517d	2026-09-07	Warnings	Exact identifier unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggets	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	ba3612b3-9696-417a-ba66-eb9dc5ea27c6	2026-09-07	Warnings	Exact identifier unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - signature scent	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	5b0ac694-66e0-437f-86cd-09f259344b89	2026-09-07	Warnings	Exact identifier unii: 3K9958V90M
ALCOHOL PREP PADS MEDIUM STERILE	ISOPROPYL ALCOHOL CLOTH	JINHUA JINGDI MEDICAL SUPPLIES CO., LTD	57cbbe72-24ec-2e4a-e063-6394a90abbd2	2026-09-07	Warnings	Exact identifier unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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