NDC 16729-005-12 - simvastatin

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: 16729-005
Requested NDC: 16729-005-12
Package NDCs from labels: 16729-005-10, 16729-005-12, 16729-005-15, 16729-005-17
Manufacturer: QPharma, Inc. | Accord Healthcare, Inc. | Northwind Health Company, LLC
Effective date: 2025-12-03
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
simvastatin - QPharma, Inc. \| Accord Healthcare, Inc. \| Northwind Health Company, LLC	QPharma, Inc. \| Accord Healthcare, Inc. \| Northwind Health Company, LLC	2025-12-03	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Accord Healthcare, Inc. \| Intas Pharmaceuticals Limited.	Accord Healthcare, Inc. \| Intas Pharmaceuticals Limited.	2025-11-14	HUMAN PRESCRIPTION DRUG LABEL
SIMVASTATIN - St Marys Medical Park Pharmacy	St Marys Medical Park Pharmacy	2024-12-11	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - A-S Medication Solutions	A-S Medication Solutions	2024-11-25	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Preferred Pharmaceuticals, Inc.	Preferred Pharmaceuticals, Inc.	2024-08-09	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-08-08	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - REMEDYREPACK INC.	REMEDYREPACK INC.	2024-07-26	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2024-07-10	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2024-06-18	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - PD-Rx Pharmaceuticals, Inc.	PD-Rx Pharmaceuticals, Inc.	2023-09-19	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - RPK Pharmaceuticals, Inc.	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - A-S Medication Solutions	A-S Medication Solutions	2023-02-04	HUMAN PRESCRIPTION DRUG LABEL
SIMVASTATIN - Direct Rx	Direct Rx	2023-01-12	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Proficient Rx LP	Proficient Rx LP	2022-05-01	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - NuCare Pharmaceuticals, Inc.	NuCare Pharmaceuticals, Inc.	2021-03-31	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Denton Pharma, Inc. DBA Northwind Pharmaceuticals	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-12-30	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Contract Pharmacy Services-PA \| Coupler Enterprises	Contract Pharmacy Services-PA \| Coupler Enterprises	2018-12-29	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - KAISER FOUNDATION HOSPITALS	KAISER FOUNDATION HOSPITALS	2018-11-19	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2018-04-26	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2018-02-27	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Unit Dose Services	Unit Dose Services	2017-07-01	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - Blenheim Pharmacal, Inc.	Blenheim Pharmacal, Inc.	2015-11-25	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - RxChange Co.	RxChange Co.	2014-11-20	HUMAN PRESCRIPTION DRUG LABEL
simvastatin - State of Florida DOH Central Pharmacy	State of Florida DOH Central Pharmacy	2014-09-30	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16729-005-10	simvastatin	30 in 1 BOTTLE	TABLET, FILM COATED	30	22
16729-005-12	simvastatin	60 in 1 BOTTLE	TABLET, FILM COATED	60	22
16729-005-15	simvastatin	90 in 1 BOTTLE	TABLET, FILM COATED	90	22
16729-005-17	simvastatin	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-005	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	21	Current NDC, Legacy NDC, 4 package rows	20240719_871251c0-36a1-4a32-9eab-ff6c1e925ca9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-005-10	EA - Each	16729-005	a62bd48a-6b38-4504-ba24-1d78d2ee6973	1	2012-07-24
16729-005-15	EA - Each	16729-005	96ac1649-092f-4666-ab20-8382a979c3d8	1	2012-07-24
16729-005-17	EA - Each	16729-005	ad81b062-50d8-4875-9e2b-b207afc1962c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]	1001
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	13
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [READYMEDS]	11
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [ST MARYS MEDICAL PARK PHARMACY]	5
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [PROFICIENT RX LP]	3
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	1
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	1
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [DIRECT RX]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [RXCHANGE CO.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SIMVASTATIN TABLET, FILM COATED [UNIT DOSE SERVICES]	1

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 3 of 125 · 2,487 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cover Creme	TITANIUM DIOXIDE	Baxter of California	31f5e8c4-523f-4596-e063-6294a90a6a12	2026-07-31	Warnings	Exact identifier unii: 15FIX9V2JP
IDkit HP ONE	CITRIC ACID ANHYDROUS AND 13C UREA	Meridian Bioscience Israel Ltd	8baab7a7-5d20-46ad-9c4a-762992ef6b51	2026-07-28	Warnings, Adverse reactions	Exact identifier unii: 2968PHW8QP
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-C	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	BEL STAR S.A.	575fb2c3-e332-8a3b-e063-6394a90a9fd9	2026-07-24	Warnings	Exact identifier unii: 15FIX9V2JP
PRENATE Restore	ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENT	Avion Pharmaceuticals, LLC	1076ba9a-0168-492f-ba9b-99fa02186092	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: PQ6CK8PD0R
PNV-DHA	ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT	Acella Pharmaceuticals, LLC	038fe2e7-dc16-485c-b5fb-746db7231347	2026-07-23	Boxed warning, Adverse reactions	Exact identifier unii: PQ6CK8PD0R
True Coast SPF 50 Mineral Sunscreen	ZINC OXIDE 18%, TITANIUM DIOXIDE 6%	Foshan Sugar Max Cosmetics CO.,Ltd	5379466d-8d14-5fc2-e063-6394a90abd7e	2026-07-22	Warnings	Exact identifier unii: 15FIX9V2JP
PNV-Omega	ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENT	Acella Pharmaceuticals, LLC	735c5531-137f-4cee-8c68-ae121045a8ff	2026-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: PQ6CK8PD0R
Calamine	CALAMINE AND ZINC OXIDE	Marie's Original Formulas LLC	57110309-9a3d-025f-e063-6394a90a015a	2026-07-22	Warnings	Exact identifier unii: 1K09F3G675
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation	OCTINOXATE AND TITANIUM DIOXIDE	SICOS ET CIE	571f23e9-1126-e32d-e063-6294a90a9951	2026-07-21	Warnings	Exact identifier unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREEN	MENS SPF50 ALL IN ONE SUNSCREEN	Lance (Guangzhou) Biological Technology Co., Ltd.	57074480-77fd-cc06-e063-6294a90a28d4	2026-07-20	Warnings	Exact identifier unii: 15FIX9V2JP
Calamine	CALAMINE AND ZINC OXIDE	Marie's Original Formulas LLC	571083ce-cd35-a638-e063-6394a90ae4c7	2026-07-20	Warnings	Exact identifier unii: 1K09F3G675
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	5711364c-f9b4-bfa6-e063-6294a90ace4a	2026-07-20	Warnings	Exact identifier unii: 15FIX9V2JP
Calamine	FERRIC OXIDE RED	Better Living Brands, LLC	c7ef0ef3-6861-4b94-af4b-371fee8c1f3d	2026-07-16	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
Bombee Honey Daily Glow Shield Sunscreen	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE	ABT ASIA Inc.	56112dff-b091-7a56-e063-6294a90a77d3	2026-07-08	Warnings	Exact identifier unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	DERMIO DERMATOLOGY LLC	562f5b0d-6a10-305d-e063-6394a90a5980	2026-07-08	Warnings	Exact identifier unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	Suzanne's Skin2soul LLC	562fbaa6-f93a-5ec4-e063-6294a90a9634	2026-07-08	Warnings	Exact identifier unii: 15FIX9V2JP
SIMVASTATIN	SIMVASTATIN	A-S Medication Solutions	e447cc46-adee-4126-8b85-f00f81a6e93c	2026-07-08	Warnings, Adverse reactions	Exact identifier rxcui: 200345 unii: AGG2FN16EV
Aussie Betta Tallow Sunscreen SPF50 SPF50	TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREEN	AUSSIE BETTA HEALTHY CARE PTY LTD	56007d82-ff5b-6c26-e063-6294a90a09b6	2026-07-07	Warnings	Exact identifier unii: 15FIX9V2JP
Artificial Tears	ARTIFICIAL TEARS	AvPAK	f18bebf2-1936-658f-e053-2a95a90a5012	2026-07-07	Warnings	Exact identifier unii: 3NXW29V3WO
EELHOE Body Coverage Perfector	TITANIUM DIOXIDE	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	5610c3b7-456b-3bc1-e063-6394a90a3fa8	2026-07-07	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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