Prenatal Plus Vitamin and Mineral Tablet Multi-Vitamin Rx Only

Manufacturer: Amneal Pharmaceuticals LLC | New Generation Wellness
Effective date: 2022-03-29
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 19
Source: full-release
Hydrated at: 2026-05-31 20:40:36

Label at a glance#

ProductPRENATAL PLUS

Active ingredientVITAMIN A ACETATE, BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE

Label structure7 sections

Indications and uses

To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non-lactating mother. It is also useful for improving nutritional status prior to conception.

Dosage and administration

As a dietary adjunct before, during and after pregnancy, take one tablet daily with a meal, or as directed by a physician.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Each Tablet Contains:

VITAMINS: Amount per Tablet

Vitamin A (from Acetate and Beta Carotene) ............................. 4000 IU

Vitamin C (Ascorbic Acid) ........................................................... 120 mg

Vitamin D-3 (Cholecalciferol) ....................................................... 400 IU

Vitamin E (dl- Alpha Tocopheryl Acetate) ...................................... 22 mg

Thiamine (Vitamin B-1) (from Thiamine Mononitrate) ................. 1.84 mg

Riboflavin (Vitamin B-2) .................................................................. 3 mg

Niacin (as Niacinamide) ................................................................ 20 mg

Vitamin B-6 (Pyridoxine HCl) ......................................................... 10 mg

Folic Acid ......................................................................................... 1 mg

Vitamin B-12 (Cyanocobalamin) ................................................... 12 mcg

MINERALS: Amount per Tablet

Calcium (as Calcium Carbonate) ................................................. 200 mg

Iron (from Ferrous Fumarate) ........................................................ 27 mg

Zinc (from Zinc Oxide) ................................................................... 25 mg

Copper (from Cupric Oxide) ........................................................... 2 mg

Other ingredients: croscarmellose sodium, FD&C Blue #2, FD&C Red #40, FD&C Yellow # 5, FD&C Yellow # 6, macrogol, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, silicon, starch, stearic acid, talc, titanium dioxide

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

WARNINGS

WARNINGS SECTION

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under age 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.

PRECAUTIONS

PRECAUTIONS SECTION

Folic acid may partially correct the hematological damage due to Vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progesses.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

As a dietary adjunct before, during and after pregnancy, take one tablet daily with a meal, or as directed by a physician.

HOW SUPPLIED

HOW SUPPLIED SECTION

Bottles of 100: NDC 65162-668-10

Bottles of 500: NDC 65162-668-50

Storage

STORAGE AND HANDLING SECTION

STORE AT CONTROLLED ROOM TEMPERATURE 15º to 30ºC (59º to 86ºF), AVOID EXCESS HEAT.

Dispense in a well closed light-resistant container, with a child resistant cap.
KEEP THIS AND ALL MEDICATION OUR OF THE REACH OF CHILDREN.
DO NOT USE IF INNER SAFETY SEAL IS BROKEN OR MISSING.

Manufactured by:
Nexgen Pharma
Colorado Springs, CO 80905

Distributed by:
Amneal Pharmaceuticals
Glasgow, KY 42141

Rev. 09-2012

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Prenatal Plus Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ASCORBIC ACID Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
CALCIUM CATION Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20230427
CHOLECALCIFEROL Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
CYANOCOBALAMIN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
PYRIDOXINE Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20170310
VITAMIN A Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cf050ccd-1144-f76a-e00d-e5698d8597d4	Product name	6	20250625
bee4fa8d-8d82-423a-a0b5-40a89dd13a99	Product name	1	20250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767	Product name	4	20250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8	Product name	2	20240805
334fe8d2-68fb-4331-a576-420e302ec069	Product name	7	20240320
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
91c62db0-0295-c81c-d10a-0856c259edd6	Product name	2	20200428
d32bc2b8-0bb7-2216-87aa-24639646e202	Product name	3	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
e92765c1-be81-432a-b909-1b10777ec378	Product name	1	20190208
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
d206bb34-ea65-399d-70d9-834f22dc2c18	Product name	3	20170724
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
0441a8f5-3835-497c-aedd-bc78cba56b2a	Product name	1	20150317
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65162-668-10	2023-07-28	C162847	48780-1	9d75b9d1-0b88-f424-e053-dadaa90a57ce	Prenatal Plus Vitamin and Mineral Tablet Multi-Vitamin Rx Only
65162-668-50	2023-07-28	C162847	48780-1	9d75b9d1-0b88-f424-e053-dadaa90a57ce	Prenatal Plus Vitamin and Mineral Tablet Multi-Vitamin Rx Only
65162-668-10	2022-01-19	C162847	48780-1	9d75b9d1-0b88-f424-e053-dadaa90a57ce	Prenatal Plus Vitamin and Mineral Tablet Multi-Vitamin Rx Only
65162-668-50	2022-01-19	C162847	48780-1	9d75b9d1-0b88-f424-e053-dadaa90a57ce	Prenatal Plus Vitamin and Mineral Tablet Multi-Vitamin Rx Only
65162-668-10	2020-01-31	C162847	48780-1	9d75b9d1-0b88-f424-e053-dadaa90a57ce	Prenatal Plus Vitamin and Mineral Tablet Multi-Vitamin Rx Only
65162-668-50	2020-01-31	C162847	48780-1	9d75b9d1-0b88-f424-e053-dadaa90a57ce	Prenatal Plus Vitamin and Mineral Tablet Multi-Vitamin Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65162-668-10	PRENATAL PLUS	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100		19
65162-668-50	PRENATAL PLUS	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500		19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-668	PRENATAL PLUS (VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC]	19	Legacy NDC, 2 package rows	20220330_12151d1c-4306-4e77-86e5-a0ee7f81d3cd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-668-10	EA - Each	65162-668	4a4ff724-e95b-437f-8203-5bda0238752d	1	2012-07-24
65162-668-50	EA - Each	65162-668	3d38ed15-6585-49a5-a931-5f89421854a3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
.ALPHA.-TOCOPHEROL ACETATE, DL-	ACTIVE INGREDIENT	WR1WPI7EW8	11
.BETA.-CAROTENE	ACTIVE INGREDIENT	01YAE03M7J	11
ASCORBIC ACID	ACTIVE INGREDIENT	PQ6CK8PD0R	11
CALCIUM CARBONATE	ACTIVE INGREDIENT	H0G9379FGK	11
CHOLECALCIFEROL	ACTIVE INGREDIENT	1C6V77QF41	11
CUPRIC OXIDE	ACTIVE INGREDIENT	V1XJQ704R4	11
CYANOCOBALAMIN	ACTIVE INGREDIENT	P6YC3EG204	11
FERROUS FUMARATE	ACTIVE INGREDIENT	R5L488RY0Q	11
FOLIC ACID	ACTIVE INGREDIENT	935E97BOY8	11
NIACINAMIDE	ACTIVE INGREDIENT	25X51I8RD4	11
PYRIDOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	68Y4CF58BV	11
RIBOFLAVIN	ACTIVE INGREDIENT	TLM2976OFR	11
THIAMINE MONONITRATE	ACTIVE INGREDIENT	8K0I04919X	11
VITAMIN A ACETATE	ACTIVE INGREDIENT	3LE3D9D6OY	11
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	11
.ALPHA.-TOCOPHEROL, DL-	ACTIVE MOIETY	7QWA1RIO01	11
.BETA.-CAROTENE	ACTIVE MOIETY	01YAE03M7J	11
ASCORBIC ACID	ACTIVE MOIETY	PQ6CK8PD0R	11
CALCIUM CATION	ACTIVE MOIETY	2M83C4R6ZB	11
CHOLECALCIFEROL	ACTIVE MOIETY	1C6V77QF41	11
CUPRIC CATION	ACTIVE MOIETY	8CBV67279L	11
CYANOCOBALAMIN	ACTIVE MOIETY	P6YC3EG204	11
FERROUS CATION	ACTIVE MOIETY	GW89581OWR	11
FOLIC ACID	ACTIVE MOIETY	935E97BOY8	11
NIACINAMIDE	ACTIVE MOIETY	25X51I8RD4	11
PYRIDOXINE	ACTIVE MOIETY	KV2JZ1BI6Z	11
RIBOFLAVIN	ACTIVE MOIETY	TLM2976OFR	11
Thiamine ION	ACTIVE MOIETY	4ABT0J945J	11
VITAMIN A	ACTIVE MOIETY	81G40H8B0T	11
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	11
.ALPHA.-TOCOPHEROL, DL-	INACTIVE INGREDIENT	7QWA1RIO01	11
ASCORBYL PALMITATE	INACTIVE INGREDIENT	QN83US2B0N	11
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	11
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	11
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	11
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	11
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	11
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	11
GELATIN	INACTIVE INGREDIENT	2G86QN327L	11
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	11
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	11
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	11
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	11
SODIUM ASCORBATE	INACTIVE INGREDIENT	S033EH8359	11
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	11
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	11
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	11
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	11
SUCROSE	INACTIVE INGREDIENT	C151H8M554	11
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	11
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 49 matching rows.

PRENATAL PLUS
VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE
VITAMIN A ACETATE
VITAMIN A
BETA CAROTENE
ASCORBIC ACID
CHOLECALCIFEROL
.ALPHA.-TOCOPHEROL ACETATE, DL-
.ALPHA.-TOCOPHEROL, DL-
THIAMINE MONONITRATE
Thiamine ION
THIAMINE
RIBOFLAVIN
NIACINAMIDE
PYRIDOXINE HYDROCHLORIDE
PYRIDOXINE
FOLIC ACID
CYANOCOBALAMIN
CALCIUM CARBONATE
CALCIUM CATION
FERROUS FUMARATE
FERROUS CATION
ZINC OXIDE
CUPRIC OXIDE
CUPRIC CATION
ASCORBYL PALMITATE
BUTYLATED HYDROXYTOLUENE
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
FD&C RED NO. 40
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6
GELATIN
HYPROMELLOSES
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
SILICON DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65162-668	65162-668-10, 65162-668-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
VITAMIN A ACETATE	3LE3D9D6OY	ACTIM
BETA CAROTENE	01YAE03M7J	ACTIB
ASCORBIC ACID	PQ6CK8PD0R	ACTIB
CHOLECALCIFEROL	1C6V77QF41	ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	ACTIM
THIAMINE MONONITRATE	8K0I04919X	ACTIR
RIBOFLAVIN	TLM2976OFR	ACTIB
NIACINAMIDE	25X51I8RD4	ACTIB
PYRIDOXINE HYDROCHLORIDE	68Y4CF58BV	ACTIB
FOLIC ACID	935E97BOY8	ACTIB
CYANOCOBALAMIN	P6YC3EG204	ACTIB
CALCIUM CARBONATE	H0G9379FGK	ACTIM
FERROUS FUMARATE	R5L488RY0Q	ACTIM
ZINC OXIDE	SOI2LOH54Z	ACTIB
CUPRIC OXIDE	V1XJQ704R4	ACTIM
ASCORBYL PALMITATE	QN83US2B0N	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	O7TSZ97GEP	IACT
.ALPHA.-TOCOPHEROL, DL-	7QWA1RIO01	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
GELATIN	2G86QN327L	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM ASCORBATE	S033EH8359	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SORBIC ACID	X045WJ989B	IACT
STARCH, CORN	O8232NY3SJ	IACT
STEARIC ACID	4ELV7Z65AP	IACT
SUCROSE	C151H8M554	IACT
SUNFLOWER OIL	3W1JG795YI	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIACETIN	XHX3C3X673	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 11 · 659 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SPONGE / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / SUBLINGUAL		409 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	GEL / TOPICAL		2 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SYRUP / ORAL		3 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / AURICULAR (OTIC)	10 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	DROPS / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SHAMPOO / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / OPHTHALMIC	0.44 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED / ORAL	25 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	14 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	INJECTION / INTRAMUSCULAR	1 %w/v		Exact identifier — unii candidate 22 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET / SUBLINGUAL	0.13 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAMUSCULAR		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	SOLUTION/ DROPS / OPHTHALMIC	0.2 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / OPHTHALMIC	1.5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 81 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, CHEWABLE / ORAL	0.41 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TROCHE / ORAL		315 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SYSTEM / INTRAVITREAL	0.02 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SWAB / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, FILM COATED / ORAL		57 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / RECTAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FOR SUSPENSION / ORAL		131 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE	1 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SUSPENSION / ORAL		4441 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, EXTENDED RELEASE / ORAL		184 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM ASCORBATE	SODIUM ASCORBATE	S033EH8359	SUSPENSION, EXTENDED RELEASE / ORAL		33 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	LOTION / TOPICAL		1000 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TAMPON / VAGINAL	62.1 mg		Exact identifier — unii candidate 81 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
0d4bdd65-75d3-49a5-b8ce-485696664dc3			12151d1c-4306-4e77-86e5-a0ee7f81d3cd	2022-03-29	Warnings	Exact identifier spl id: 0d4bdd65-75d3-49a5-b8ce-485696664dc3 spl set id: 12151d1c-4306-4e77-86e5-a0ee7f81d3cd

Reported adverse events (FAERS/openFDA)#

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