FDA.reportPublic FDA data

FolateXcel

Manufacturer
Trifluent Pharma
Effective date
2025-08-07
Label type
DIETARY SUPPLEMENT
Version
2
Source
full-release
Hydrated at
2026-06-01 02:51:55

Label at a glance#

ProductFolateXcel
Active ingredientASCORBIC ACID, BETA CAROTENE, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HCL, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS BISGLYCINATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, ZINC OXIDE
Label structure7 sections

Dosage and administration

Before, during and/or after pregnancy, one tablet daily with food or as directed by a physician.

Label contents#

Full prescribing information#

HEALTH CLAIM SECTION

FolateXcelPrenatal/Postnatal Dietary Supplement - Dispensed by Prescription

STATEMENT OF IDENTITY SECTION

FolateXcel- beta carotene, ascorbic acid, cholecalciferol, dl-alpha-tocopheryl acetate, pyridoxine hydrochloride, folic acid, 5-methyl tetrahydrofolate calcium salt, cyanocobalamin, biotin, calcium carbonate, ferrous bisglycinate chelate, potassium iodine, and magnesium oxide, zinc oxide tablet.

Serving Size: 1 Tablet

Servings Per Container: 30

Each Tablet Contains:

%DV

Vitamin A (as Beta-Carotene)                     

300 mcg RAE 

23%

Vitamin C (as ascorbic acid) 

60 mg

50%

Vitamin D3 (as cholecalciferol)

10 mcg

67%

Vitamin E (as dl-Alpha-Tocopheryl Acetate)

4.5 mg

24%

Vitamin B6 (as pyridoxine HCl)

26 mg

1300%

Folate

(From Folic Acid) (1000 mcg folic acid)                

(From 5-Methyl Tetrahydrofolate, Calcium Salt)

1670 mcg DFE

278%

 Vitamin B12 (as Cyanocobalamine)

13 mcg

464%

Biotin

280 mcg

800%

Calcium (from Calcium Carbonate) 

80 mg

6%

FerrochelTM Iron (as ferrous BisGlycinate Chelate)

20 mg

74%

Iodine (as potassium iodide)

150 mcg

52%

Magnesium (as Magnesium oxide)

25 mg

6%

Zinc (as Zinc Oxide)                                                                                                                     12 mg                                  92%

*Percent Daily Value (DV) for pregnant and/or lactating women

OTHER INGREDIENTS: Modified Cellulose, Croscarmellose Sodium, Stearic Acid, Silicon Dioxide, Magnesium Stearate.  Film Coating: (Hydroxypropyl Methylcellulose, Polyethylene Glycol, Titanium Dioxide, FD&C Blue#1).

DESCRIPTION

HEALTH CLAIM SECTION

Preservative-Free, Gluten-Free, No Sugar, Starch, Artificial Flavors, Wheat, Yeast, or Corn Added.   

Double safety cealed for your portection.  Do not sue if either seal is broken or missing.  

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Before, during and/or after pregnancy, one tablet daily with food or as directed by a physician.

STORAGE

SAFE HANDLING WARNING SECTION

Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] Avoid excessive heat, light
and moisture.

Distributed by:

Trifluent Pharma, LLC.

San Antonio, TX

892039

Rev 01 07/2025

Ferrochel is a registered trademark of Balchem Corporation or its subsidiares.   

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

WARNING

WARNINGS 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 the case of acceidental overdose, call a docotr or poison control center immediately. 

KEEP OUT OF REACH OF CHILDREN 

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
LEVOMEFOLIC ACID Pharmacologic Class Indexing1Indexing - Pharmacologic Class20230428
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
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bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
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030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
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362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
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d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
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11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
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5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
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fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73352-892-30FolateXcel30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73352-892-30EA - Each73352-8925b5d424b-86ef-4738-a36b-e0740bbfe3f012025-09-12

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73352-89273352-892-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASCORBIC ACIDPQ6CK8PD0RACTIB
BETA CAROTENE01YAE03M7JACTIB
CHOLECALCIFEROL1C6V77QF41ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8ACTIM
PYRIDOXINE HCL68Y4CF58BVACTIM
FOLIC ACID935E97BOY8ACTIB
LEVOMEFOLATE CALCIUMA9R10K3F2FACTIM
CYANOCOBALAMINP6YC3EG204ACTIB
BIOTIN6SO6U10H04ACTIB
CALCIUM CARBONATEH0G9379FGKACTIM
FERROUS BISGLYCINATESFW1D987QVACTIM
POTASSIUM IODIDE1C4QK22F9JACTIM
MAGNESIUM OXIDE3A3U0GI71GACTIM
STEARIC ACID4ELV7Z65APIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ZINC OXIDESOI2LOH54ZACTIM
HYDROXYPROPYL METHYLCELLULOSE3NXW29V3WOIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-08-03legacy-cache2026-10-22 23:46:48

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ascorbic AcidASCORBIC ACIDRenova Pharmaceuticals LLCa6481bae-2397-44c7-a51d-4f47ad91bd2c2026-08-19Warnings, Adverse reactionsName fallback
generic name: ASCORBIC ACID
AscorASCORBIC ACIDMcGuff Pharmaceuticals, Inc.388aad52-fc01-4784-9791-1dbc80c693062026-05-29Warnings, Adverse reactionsName fallback
generic name: ASCORBIC ACID
Ascorbic AcidASCORBIC ACIDFresenius Kabi USA, LLC1606e29f-0e80-4069-b688-daab9cbff20a2025-12-17Warnings, Adverse reactionsName fallback
generic name: ASCORBIC ACID
Skin Renewing SerumASCORBIC ACIDGuangzhou Danting Bath&Body Care Industry Co. Ltd396c2a8d-ac95-cbef-e063-6294a90aff392025-08-23WarningsName fallback
generic name: ASCORBIC ACID

Reported adverse events (FAERS/openFDA)#

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