Label at a glance#

Producthealthy mamaBE WELL ROUNDED BE WELL ROUNDED

Active ingredient.BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS BISGLYCINATE, ZINC OXIDE, COPPER, BIOTIN, CALCIUM PANTOTHENATE, MAGNESIUM OXIDE

Label structure8 sections

Boxed warning

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.

Contacts and useful links#

PhoneLabel contact1-855-773-4426

Websitewww.healthymamabrand.com

www.healthymamabrand.com

Label contents#

Full prescribing information#

Supplement Facts

OTC - ACTIVE INGREDIENT SECTION

Serving Size: 1 caplet

Serving per Container: 60

Annual Per Serving % DV*

Vitamin A ( as beta Carotene) 4000IU 50%

Vitamin C ( as Ascorbic Acid) 120mg 200%

Vitamin D3 ( as Cholecalciferol) 400IU 100%

Vitamin E( from dl-Alpha Tocopheryl Acetate) 30IU 100%

Thiamin (B1) 1.8mg 108%

Riboflavin 1.7mg 85%

Niacin (B3) 20mg 100%

Vitamin B6 (from Pyridoxine Hydrocholride) 2.6mg 104%

Folic Acid 800mcg 100%

Vitamin B12(as Methylcobalamin) 8mcg 100%

Biotin 30 mcg 10%

Pantothenic Acid( d-Calcium Patothenate) 10 mg 100%

Calcium( from Calcium Carbonate) 200 mg 15%

iron(Ferrous Bisglycinate Chelate) 28 mg 156%

Magnesium ( from Chelate and oxide) 30 mg 8%

Zinc ( from Zinc Oxide) 25 mg 167%

Copper (from Chelate) 2 mg 100%

% Daily value9DV) for pregnant and lactating women

Other ingredients: Microcrystalline cellulose, croscarmellose sodium, stearic acid, gelatin, corn starch, maltodextrin, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide , sunflower oil, dicalcium phosphate dihydrate, sucrose, Ascorbyl palmitate, dl-alpha tocopherol, sodium ascorbate, FD and C Red #40, red oxide, triglycerides, sodium benzoate, FD and C Yellow # 6, sorbic acid, propylene glycol, triacetin

INDICATIONS & USAGE SECTION

PRENATAL VITAMINS

Suggested Use

DOSAGE & ADMINISTRATION SECTION

Adults-take one caplet daily with water, preferably with a mean, as a dietary supplement, or as directed by doctor. As with any supplement if you are pregnent, nursing, or taking medication.consult your doctor before use.

Warning

BOXED WARNING 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

WARNINGS AND PRECAUTIONS SECTION

Folic Acid may partially correct the hematological damage due to vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progresses.

Other information

SPL UNCLASSIFIED SECTION

Store at a room temperature.

Keep lid tightly closed in a dry place
Do not use if imprinted safety seal under cap is broken or missing
keep out of reach of children

Questions?

OTC - QUESTIONS SECTION

If you have any questions or comments, or to report an adverse event, please contact 1-855-preg-i-am(1-855-773-4426)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

American Pregnancy Association

healthy mama

BE WELL ROUNDED!

easy to swallow

PRENATAL VITAMINS

60 caplets

DISTRIBUTED BY:

Maternal Science, Inc

50 Tice Blvd, Ste 340, woodcliff Lake ,Nj 07677

www.healthymamabrand.comUntitledd.jpg

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
COPPER Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
MAGNESIUM CATION Pharmacologic Class Indexing	4	Indexing - Pharmacologic Class	20180813
NIACIN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
PYRIDOXINE Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20170310
ZINC CATION Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6e3c022f-0786-43f1-8857-edff89d5153f	Product name	1	20260309
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
c599c4a0-705d-4ebb-ab1f-977af038f96a	Product name	1	20251124
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
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
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
334fe8d2-68fb-4331-a576-420e302ec069	Product name	7	20240320
efd58652-cb8f-4018-91ca-4b0eb2ff729f	Product name	7	20240226
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62	Product name	3	20210309
91c62db0-0295-c81c-d10a-0856c259edd6	Product name	2	20200428
d32bc2b8-0bb7-2216-87aa-24639646e202	Product name	3	20190619
e2dae634-14ed-febf-08ee-93196433b5b7	Product name	9	20190614
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
e92765c1-be81-432a-b909-1b10777ec378	Product name	1	20190208
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
e7e58cd3-cacb-49df-8d34-1ee335614abb	Product name	1	20150609
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
0a5e5249-329b-0cff-e714-77159f193a87	Product name	1	20140508
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
d394f843-7479-dc48-dbd3-232266c5548c	Product name	1	20140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212	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
58154-107-60	2019-11-27	C162847	48780-1	9855d018-ef72-cd31-e053-dbdaa90ab51a	healthy mama PRENATAL VITAMINS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58154-107-60	healthy mamaBE WELL ROUNDED BE WELL ROUNDED	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58154-107	HEALTHY MAMABE WELL ROUNDED BE WELL ROUNDED (.BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS BISGLYCINATE, ZINC OXIDE, COPPER, CALCIUM PANTOTHENATE,MAGNESIUM OXIDE ) TABLET, FILM COATED [MATERNAL SCIENCE, LLC]	2	Legacy NDC, 1 package rows	20130709_b0addefd-148c-423b-bcff-332c255a2d90.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
.ALPHA.-TOCOPHEROL ACETATE, DL-	ACTIVE INGREDIENT	WR1WPI7EW8	2
.BETA.-CAROTENE	ACTIVE INGREDIENT	01YAE03M7J	2
ASCORBIC ACID	ACTIVE INGREDIENT	PQ6CK8PD0R	2
BIOTIN	ACTIVE INGREDIENT	6SO6U10H04	2
CALCIUM CARBONATE	ACTIVE INGREDIENT	H0G9379FGK	2
CALCIUM PANTOTHENATE	ACTIVE INGREDIENT	568ET80C3D	2
CHOLECALCIFEROL	ACTIVE INGREDIENT	1C6V77QF41	2
COPPER	ACTIVE INGREDIENT	789U1901C5	2
FERROUS BISGLYCINATE	ACTIVE INGREDIENT	SFW1D987QV	2
FOLIC ACID	ACTIVE INGREDIENT	935E97BOY8	2
MAGNESIUM OXIDE	ACTIVE INGREDIENT	3A3U0GI71G	2
METHYLCOBALAMIN	ACTIVE INGREDIENT	BR1SN1JS2W	2
NIACIN	ACTIVE INGREDIENT	2679MF687A	2
PYRIDOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	68Y4CF58BV	2
RIBOFLAVIN	ACTIVE INGREDIENT	TLM2976OFR	2
THIAMINE	ACTIVE INGREDIENT	X66NSO3N35	2
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	2
.BETA.-CAROTENE	ACTIVE MOIETY	01YAE03M7J	2
ALPHA-TOCOPHEROL, DL-	ACTIVE MOIETY	7QWA1RIO01	2
ASCORBIC ACID	ACTIVE MOIETY	PQ6CK8PD0R	2
BIOTIN	ACTIVE MOIETY	6SO6U10H04	2
CALCIUM CATION	ACTIVE MOIETY	2M83C4R6ZB	2
CHOLECALCIFEROL	ACTIVE MOIETY	1C6V77QF41	2
COPPER	ACTIVE MOIETY	789U1901C5	2
FERROUS CATION	ACTIVE MOIETY	GW89581OWR	2
FOLIC ACID	ACTIVE MOIETY	935E97BOY8	2
MAGNESIUM CATION	ACTIVE MOIETY	T6V3LHY838	2
METHYLCOBALAMIN	ACTIVE MOIETY	BR1SN1JS2W	2
NIACIN	ACTIVE MOIETY	2679MF687A	2
PANTOTHENIC ACID	ACTIVE MOIETY	19F5HK2737	2
PYRIDOXINE	ACTIVE MOIETY	KV2JZ1BI6Z	2
RIBOFLAVIN	ACTIVE MOIETY	TLM2976OFR	2
THIAMINE ION	ACTIVE MOIETY	4ABT0J945J	2
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	2
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	2
ASCORBYL PALMITATE	INACTIVE INGREDIENT	QN83US2B0N	2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	2
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
SODIUM ASCORBATE	INACTIVE INGREDIENT	S033EH8359	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	2
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	2
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	2

Products#

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

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

healthy mamaBE WELL ROUNDED BE WELL ROUNDED
.BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS BISGLYCINATE, ZINC OXIDE, COPPER, CALCIUM PANTOTHENATE,MAGNESIUM OXIDE
.BETA.-CAROTENE
ASCORBIC ACID
CHOLECALCIFEROL
.ALPHA.-TOCOPHEROL ACETATE, DL-
ALPHA-TOCOPHEROL, DL-
THIAMINE
THIAMINE ION
RIBOFLAVIN
NIACIN
PYRIDOXINE HYDROCHLORIDE
PYRIDOXINE
FOLIC ACID
METHYLCOBALAMIN
CALCIUM CARBONATE
CALCIUM CATION
FERROUS BISGLYCINATE
FERROUS CATION
ZINC OXIDE
ZINC CATION
COPPER
ASCORBYL PALMITATE
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
HYPROMELLOSES
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
.ALPHA.-TOCOPHEROL
STARCH, CORN
PROPYLENE GLYCOL
SILICON DIOXIDE
SODIUM ASCORBATE
SODIUM BENZOATE
SORBIC ACID
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58154-107	58154-107-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
.BETA.-CAROTENE	01YAE03M7J	ACTIB
ASCORBIC ACID	PQ6CK8PD0R	ACTIB
CHOLECALCIFEROL	1C6V77QF41	ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	ACTIM
THIAMINE	X66NSO3N35	ACTIB
RIBOFLAVIN	TLM2976OFR	ACTIB
NIACIN	2679MF687A	ACTIB
PYRIDOXINE HYDROCHLORIDE	68Y4CF58BV	ACTIB
FOLIC ACID	935E97BOY8	ACTIB
METHYLCOBALAMIN	BR1SN1JS2W	ACTIB
CALCIUM CARBONATE	H0G9379FGK	ACTIM
FERROUS BISGLYCINATE	SFW1D987QV	ACTIM
ZINC OXIDE	SOI2LOH54Z	ACTIM
COPPER	789U1901C5	ACTIB
ASCORBYL PALMITATE	QN83US2B0N	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	L11K75P92J	IACT
FD&C RED NO. 40	WZB9127XOA	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
.ALPHA.-TOCOPHEROL	H4N855PNZ1	IACT
STARCH, CORN	O8232NY3SJ	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM ASCORBATE	S033EH8359	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SORBIC ACID	X045WJ989B	IACT
STEARIC ACID	4ELV7Z65AP	IACT
SUCROSE	C151H8M554	IACT
SUNFLOWER OIL	3W1JG795YI	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIACETIN	XHX3C3X673	IACT
BIOTIN	6SO6U10H04	ACTIB
CALCIUM PANTOTHENATE	568ET80C3D	ACTIM
MAGNESIUM OXIDE	3A3U0GI71G	ACTIB

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 · 609 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	POWDER, FOR SUSPENSION / ORAL		34 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.02 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, EXTENDED RELEASE / ORAL	119.7 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	LOTION / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, DELAYED RELEASE PELLETS / ORAL		127 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET / SUBLINGUAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	POWDER, FOR SUSPENSION / ORAL	1203 mg/5ml		Exact identifier — unii candidate 26 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	14 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, EXTENDED RELEASE / ORAL		117 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	FILM / SUBLINGUAL	0.03 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	CAPSULE, EXTENDED RELEASE / ORAL	301.7 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / ORAL	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	WAFER / ORAL	NA		Exact identifier — unii candidate 44 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	GEL / TOPICAL		4522 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET / ORAL		2240 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		2 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET, COATED / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	DROPS / ORAL	200 mg/1ml		Exact identifier — unii candidate 81 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / TOPICAL		104 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, COATED / ORAL	5.6 mg		Exact identifier — unii candidate 15 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
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CAPSULE / ORAL	8.5 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / RESPIRATORY (INHALATION)	25 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SUSPENSION / ORAL		160 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET / ORAL	30 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	POWDER / SUBLINGUAL		30 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, EXTENDED RELEASE / ORAL		239 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / BUCCAL		18 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	PASTE / DENTAL		252 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	CAPSULE / ORAL	401 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION/ DROPS / ORAL		90 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INHALANT / ORAL	0.08 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	POWDER, FOR SUSPENSION / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		21 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	POWDER / ORAL	20 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, ORALLY DISINTEGRATING / ORAL		12 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	PASTILLE / ORAL	143 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	CAPSULE / ORAL		200 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii candidate 22 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
88b9de99-b1a3-41ae-b06c-65c819fa94bb			b0addefd-148c-423b-bcff-332c255a2d90	2013-07-09	Boxed warning, Warnings	Exact identifier spl id: 88b9de99-b1a3-41ae-b06c-65c819fa94bb spl set id: b0addefd-148c-423b-bcff-332c255a2d90

Reported adverse events (FAERS/openFDA)#

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