Vitafol

Manufacturer
Everett Laboratories, Inc. | Interge Pharmaceutical, Inc, | Blispak Acquisition Corporation | Nutra-Med Packaging, Inc
Effective date
2012-04-18
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:14:55

Label at a glance#

ProductVitafol Plus
Active ingredientOmega-3 Fatty Acids, Niacin, .Alpha.-Tocopherol, Vitamin D, Lauric Acid, Vitamin A, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc, Copper, Iodine, Magnesium, Folic Acid
Label structure11 sections

Boxed warning

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

Indications and uses

Vitafol ® -Plus is indicated to provide vitamin, mineral and omega-3 fatty acid supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother, including individuals with known allergies to fish. Vitafol ® -Plus does not contain fish, fish oils, fish proteins or fish byproducts.

Dosage and administration

Before, during and after pregnancy, one softgel capsule daily, or as directed by a physician.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx only

DESCRIPTION SECTION

Composition

SPL UNCLASSIFIED SECTION

Each Softgel Capsule Contains:

Vitamins and Minerals:
Vitamin A (as beta carotene)1100 IU
Vitamin C (as ascorbic acid)12 mg
Vitamin D3 (as cholecalciferol)1000 IU
Vitamin E (as dl-alpha tocopheryl acetate)10 IU
Thiamin (Vitamin B1) (as thiamine mononitrate)1.6 mg
Riboflavin (Vitamin B2)1.8 mg
Niacin (as nicotinamide)15 mg
Vitamin B6 (as pyridoxine hydrochloride)2.5 mg
Folic Acid1 mg
Vitamin B12 (as cyanocobalamin)12 mcg
Elemental Iron (as polysaccharide iron complex)27mg
Iodine (as potassium iodide)200 mcg
Magnesium (as magnesium oxide)5 mg
Zinc (as zinc oxide)15 mg
Copper (as copper oxide)2 mg
Lauric Acid60 mg
Omega-3 FATTY ACID
DHA from Algal (crypthecodinium) Oil200 mg

Other Ingredients

SPL UNCLASSIFIED SECTION

Gelatin, Sorbitol, Glycerin, Soybean Oil, USP Purified Water, Yellow Beeswax, Soy Lecithin, FD&C Blue #1, Titanium Dioxide (color), High Oleic Sunflower Oil, Tocopherols, Ascorbyl Palmitate, FD&C Yellow #5, FD&C Red #40.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Vitafol®-Plus is indicated to provide vitamin, mineral and omega-3 fatty acid supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother, including individuals with known allergies to fish. Vitafol®-Plus does not contain fish, fish oils, fish proteins or fish byproducts.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Vitafol®-Plus is contraindicated in patients with hypersensitivity to any of its components or color additives.

Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid.

Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc), pyridoxine responsive anemia, or cirrhosis of the liver.

Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitamin B-12)

WARNING

BOXED WARNING SECTION

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

WARNING/PRECAUTIONS

WARNINGS SECTION

Vitafol-Plus should be used with caution in patients with known sensitivity or allergy to soy.

Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues. Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur.

Iodine should be used with caution in patients with an overactive thyroid.

Prolonged use of iron salts may produce iron storage disease.

Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive.

The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency.

Consumption of more than 3 grams of omega-3 fatty acids per day from all sources may lead to excessive bleeding. Supplemental intake of omega-3 fatty acids such as DHA exceeding 2 grams per day is not recommended.

Avoid Overdosage. Keep out of the reach of children.

Drug Interactions

DRUG INTERACTIONS SECTION

Medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism.

Medications for hypertension used in conjunction with iodine supplementation may increase potassium.

High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs carbamazepine, fosphenytoin, phenytoin, phenobarbitol, and valproic acid. Folic acid may decrease a patient's response to methotrexate.

Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.

Zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions.

Consult appropriate references for additional specific vitamin-drug interactions.

Information for Patients

INFORMATION FOR PATIENTS SECTION

Patients should be counseled to disclose all medical conditions, including pregnancy and breast-feeding, and the use of all medications and dietary supplements.

Pediatric Use

PEDIATRIC USE SECTION

Not for Pediatric Use.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol®-Plus. However, allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Before, during and after pregnancy, one softgel capsule daily, or as directed by a physician.

HOW SUPPLIED

HOW SUPPLIED SECTION

STORAGE AND HANDLING SECTION

Vitafol®-Plus is available as a purple, oval shaped softgel capsule imprinted EV0092. Available in Box of Unit-Dose pack of 30 (5 child resistant blister cards of 6 softgel capsules) (NDC0642-0092-30), and as professional samples (NDC0642-0092-01). Store at room temperature, approximately 15°-30°C (59°-86°F). Avoid excessive heat, moisture and protect from light.

SPL UNCLASSIFIED SECTION

Rx only

Manufactured for
EVERETT LABORATORIES, INC.
West Orange, NJ 07052
1-877-324-9349

Patent Pending
Vitafol® is a trademark of Everett Laboratories, Inc.

life's DHA is a trademark of DSM.
U.S. Patent No. 5,492,938; 7,163,811

(Rev. 03/12)

PRINCIPAL DISPLAY PANEL - 30 Capsule Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0642-0092-30

Vitafol®-Plus
Prenatal Supplement with DHA

Small, All-In-One,
Once Daily Softgel Capsule

EV0092

Actual Size

DOES NOT CONTAIN
FISH OIL

life's DHA
HEALTHY BRAIN, EYES, HEART™

Unit Dose Pack
30 Softgel Capsules

Rx only
Patent Pending

PRINCIPAL DISPLAY PANEL - 30 Capsule Carton
PRINCIPAL DISPLAY PANEL - 30 Capsule Carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0642-0092-012020-01-31C16284748780-19d75b9d1-0a92-f424-e053-dadaa90a57ceVitafol ® -Plus Prenatal Supplement with DHA
0642-0092-302020-01-31C16284748780-19d75b9d1-0a92-f424-e053-dadaa90a57ceVitafol ® -Plus Prenatal Supplement with DHA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0642-0092-01Vitafol Plus4 in 1 BLISTER PACKCAPSULE, LIQUID FILLED42
0642-0092-01Vitafol Plus1 in 1 BOXCAPSULE, LIQUID FILLED12
0642-0092-30Vitafol Plus5 in 1 BOXCAPSULE, LIQUID FILLED52
0642-0092-30Vitafol Plus6 in 1 BLISTER PACKCAPSULE, LIQUID FILLED62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0642-0092VITAFOL PLUS (OMEGA-3 FATTY ACIDS, NIACIN, .ALPHA.-TOCOPHEROL, VITAMIN D, LAURIC ACID, VITAMIN A, ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, IRON, ZINC, COPPER, IODINE, MAGNESIUM, AND FOLIC ACID) CAPSULE, LIQUID FILLED [EVERETT LABORATORIES, INC.]2Legacy NDC, 4 package rows20120423_3af5077a-54ee-41de-8750-dce3eea327e6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0642-0092-30EA - Each0642-0092be066f9b-812a-49a3-af50-26f1a79854ce12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
.Alpha.-TocopherolACTIVE INGREDIENTH4N855PNZ12
Ascorbic AcidACTIVE INGREDIENTPQ6CK8PD0R2
CopperACTIVE INGREDIENT789U1901C52
CyanocobalaminACTIVE INGREDIENTP6YC3EG2042
Folic AcidACTIVE INGREDIENT935E97BOY82
IodineACTIVE INGREDIENT9679TC07X42
IronACTIVE INGREDIENTE1UOL152H72
Lauric AcidACTIVE INGREDIENT1160N9NU9U2
MagnesiumACTIVE INGREDIENTI38ZP9992A2
NiacinACTIVE INGREDIENT2679MF687A2
Omega-3 Fatty AcidsACTIVE INGREDIENT71M78END5S2
Pyridoxine HydrochlorideACTIVE INGREDIENT68Y4CF58BV2
RiboflavinACTIVE INGREDIENTTLM2976OFR2
Thiamine MononitrateACTIVE INGREDIENT8K0I04919X2
Vitamin AACTIVE INGREDIENT81G40H8B0T2
Vitamin DACTIVE INGREDIENT9VU1KI44GP2
ZincACTIVE INGREDIENTJ41CSQ7QDS2
.Alpha.-TocopherolACTIVE MOIETYH4N855PNZ12
.Beta.-CaroteneACTIVE MOIETY01YAE03M7J2
Ascorbic AcidACTIVE MOIETYPQ6CK8PD0R2
CholecalciferolACTIVE MOIETY1C6V77QF412
Cupric OxideACTIVE MOIETYV1XJQ704R42
CyanocobalaminACTIVE MOIETYP6YC3EG2042
DoconexentACTIVE MOIETYZAD9OKH9JC2
Folic AcidACTIVE MOIETY935E97BOY82
IodineACTIVE MOIETY9679TC07X42
IronACTIVE MOIETYE1UOL152H72
Lauric AcidACTIVE MOIETY1160N9NU9U2
Magnesium OxideACTIVE MOIETY3A3U0GI71G2
NiacinamideACTIVE MOIETY25X51I8RD42
PyridoxineACTIVE MOIETYKV2JZ1BI6Z2
RiboflavinACTIVE MOIETYTLM2976OFR2
ThiamineACTIVE MOIETYX66NSO3N352
Zinc OxideACTIVE MOIETYSOI2LOH54Z2
Ascorbyl PalmitateINACTIVE INGREDIENTQN83US2B0N2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBD2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOA2
FD&C Yellow No. 5INACTIVE INGREDIENTI753WB2F1M2
GelatinINACTIVE INGREDIENT2G86QN327L2
GlycerinINACTIVE INGREDIENTPDC6A3C0OX2
Lecithin, SoybeanINACTIVE INGREDIENT1DI56QDM622
SorbitolINACTIVE INGREDIENT506T60A25R2
Soybean OilINACTIVE INGREDIENT241ATL177A2
Sunflower OilINACTIVE INGREDIENT3W1JG795YI2
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JP2
TocopherolINACTIVE INGREDIENTR0ZB2556P82
WaterINACTIVE INGREDIENT059QF0KO0R2
Yellow WaxINACTIVE INGREDIENT2ZA36H0S2V2

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0642-00920642-0092-30, 0642-0092-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

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 6 · 324 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPPASTE / DENTAL0.5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
Lecithin, SoybeanSOYBEAN LECITHIN1DI56QDM62TABLET, FILM COATED / ORAL0.33 mgExact identifier — unii candidate
7 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOASUSPENSION / ORAL100 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
GelatinGELATIN2G86QN327LTABLET, DELAYED RELEASE / ORAL19 mgExact identifier — unii candidate
44 equally ranked IID candidates
SorbitolSORBITOL506T60A25RCREAM, AUGMENTED / TOPICAL15 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
GelatinGELATIN2G86QN327LTABLET, ORALLY DISINTEGRATING / SUBLINGUAL13 mgExact identifier — unii candidate
44 equally ranked IID candidates
Lecithin, SoybeanSOYBEAN LECITHIN1DI56QDM62AEROSOL, METERED / RESPIRATORY (INHALATION)0.1 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
GelatinGELATIN2G86QN327LPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
SorbitolSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii candidate
44 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
37 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
Ascorbyl PalmitateASCORBYL PALMITATEQN83US2B0NSOLUTION / TOPICALNAExact identifier — unii candidate
6 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
28 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPSYSTEM / TOPICAL420 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSUSPENSION / ORAL1 mgExact identifier — unii candidate
37 equally ranked IID candidates
SorbitolSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
44 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING / ORAL6 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOACONCENTRATE / ORAL0.04 mg/1mlExact identifier — unii candidate
28 equally ranked IID candidates
SorbitolSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii candidate
44 equally ranked IID candidates
GelatinGELATIN2G86QN327LDROPS / NASAL50 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
GelatinGELATIN2G86QN327LSYRUP / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOACAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
SorbitolSORBITOL506T60A25RGUM, CHEWING / BUCCAL5110 mgExact identifier — unii candidate
44 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MPOWDER / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
SorbitolSORBITOL506T60A25RINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1.04 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDCREAM / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPGRANULE, FOR SUSPENSION / ORAL143 mgExact identifier — unii candidate
40 equally ranked IID candidates
SorbitolSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii candidate
44 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii candidate
37 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
TocopherolTOCOPHEROLR0ZB2556P8TABLET / ORAL0.08 mgExact identifier — unii candidate
5 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOATABLET / ORAL7 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / SUBLINGUAL0.03 mgExact identifier — unii candidate
37 equally ranked IID candidates
GelatinGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS14 mgExact identifier — unii candidate
44 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPGUM, CHEWING / BUCCAL182 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MCAPSULE / ORAL652 mgExact identifier — unii candidate
22 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii candidate
40 equally ranked IID candidates
SorbitolSORBITOL506T60A25RTABLET, EXTENDED RELEASE / ORAL428 mgExact identifier — unii candidate
44 equally ranked IID candidates
GelatinGELATIN2G86QN327LELIXIR / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL42 mgExact identifier — unii candidate
40 equally ranked IID candidates
Yellow WaxYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 mgExact identifier — unii candidate
9 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSYSTEM / TOPICAL6300 mgExact identifier — unii candidate
44 equally ranked IID candidates
GelatinGELATIN2G86QN327LGUM, CHEWING / BUCCAL102 mgExact identifier — unii candidate
44 equally ranked IID candidates
GelatinGELATIN2G86QN327LPASTE / DENTAL252 mgExact identifier — unii candidate
44 equally ranked IID candidates
GelatinGELATIN2G86QN327LCAPSULE, EXTENDED RELEASE / ORAL1229 mgExact identifier — unii candidate
44 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MSOLUTION / TOPICAL0.06 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
GelatinGELATIN2G86QN327LCAPSULE, LIQUID FILLED / ORAL1042 mgExact identifier — unii candidate
44 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SUSPENSION / ORAL1 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPLOTION / TOPICALNAExact identifier — unii candidate
40 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCREAM / TOPICAL80 mgExact identifier — unii candidate
40 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bb1edb09-09b6-48dc-9acb-1592639035e63af5077a-54ee-41de-8750-dce3eea327e62012-04-18Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: bb1edb09-09b6-48dc-9acb-1592639035e6
spl set id: 3af5077a-54ee-41de-8750-dce3eea327e6

Reported adverse events (FAERS/openFDA)#

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