FDA.reportPublic FDA data

Folic Acid

Manufacturer
Marlex Pharmaceuticals Inc
Effective date
2019-03-13
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:49:14

Label at a glance#

ProductFolic Acid
Active ingredientFOLIC ACID
Label structure5 sections

Label contents#

Full prescribing information#

Suggested Use:

DOSAGE & ADMINISTRATION SECTION

As a dietary supplement, take 1 or 2 tablets daily. Daily folic acid intake should not exceed 1000mcg.

Supplement Facts

STATEMENT OF IDENTITY SECTION

Serving Size: 1 Tablet

Serving per container: 100

Amount Per Tablet %Daily Value
Folic Acid………………………………….400mcg………………………………100%

OTHER INGREDIENTS:

SAFE HANDLING WARNING SECTION

Microcrystalline Cellulose, Dicalcium Phosphate, Stearic Acid, Colloidal Silicon Dioxide, Magnesium Stearate, Croscarnellouse Sodium

WARNING:

WARNINGS SECTION

If you are pregnant, nursing, taking any medications or have any medical condition, consult your doctor before use. Discontinue use and consult your doctor if any adverse reactions occurs.

KEEP OUT OF REACH OF CHILDREN. DO NOT USE IF IMPRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

  • Store at room temperature 59° - 86° (15° - 30°)
  • Keep bottle tightly closed.

Nutrition Information: Folic acid, which is also known as vitamin B9, supports cellular energy productions in the body. Everyone needs folic acid, but it’s particularly important for the women of childbearing age because folic acid plays a critical role in the proper develop of the baby’s nervous system. Adequate folic acid in healthful diets may reduce a woman’s risk of having a child with a neural tube defect.

Manufactured for/Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev. 03/19 HP

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10135-0180-01
Folic Acid
400 mcg
100 TABLETS

PRINCIPAL DISPLAY PANEL NDC 10135-0180-01 Folic Acid 400 mcg 100 TABLETSPRINCIPAL DISPLAY PANEL NDC 10135-0180-01 Folic Acid 400 mcg 100 TABLETS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198640folic acid 400 MCG Oral TabletPSN1
198640folic acid 0.4 MG Oral TabletSCD1
198640folate 0.4 MG Oral TabletSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-180-01Folic Acid100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-180FOLIC ACID TABLET [MARLEX PHARMACEUTICALS INC]11 package rows20190315_068e0b77-319c-4cf7-8c71-c7a8d4da98fa.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-180-01EA - Each10135-1802a525974-60a7-4712-8071-49e1d30d647712019-04-11

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10135-18010135-180-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
FOLIC ACID935E97BOY8ACTIB
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
STEARIC ACID4ELV7Z65APIACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML

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 4 · 61 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Folic AcidFOLIC ACIDREMEDYREPACK INC.bda4687e-929a-434d-ab59-909cf2ed73a22026-09-11Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
Folic AcidFOLIC ACIDREMEDYREPACK INC.368b69a8-a021-47e3-a6d7-e3497d7363b12026-09-04Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
Folic AcidFOLIC ACIDRising Pharma Holdings, Inc.0baa10dd-6d1d-4946-8236-566451132da32026-07-24Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
Folic AcidFOLIC ACIDNorthwind Health Company, LLC03b0aee4-804a-de63-e063-6394a90a66352026-07-13Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
FOLIC ACIDFOLIC ACIDUnit Dose Solutions, Inc.54db8b21-87b9-5e0c-e063-6394a90ae8ea2026-06-22Warnings, Adverse reactionsName fallback
brand name: FOLIC ACID
generic name: FOLIC ACID
VitramynFOLIC ACIDPureTek Corporationc8af7616-5178-6df0-e053-2a95a90a334d2026-06-18Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
FOLIC ACIDFOLIC ACIDCoupler LLC544e394d-3555-8ab1-e063-6394a90ade002026-06-15Warnings, Adverse reactionsName fallback
brand name: FOLIC ACID
generic name: FOLIC ACID
Folic AcidFOLIC ACIDMajor Pharmaceuticals7778ac96-7817-455a-a177-22ecb276c67f2026-05-26Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
Folic AcidFOLIC ACIDQUAGEN PHARMACEUTICALS LLC354366ea-3702-4706-9fc0-0244b7278bd82026-05-20Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
Folic AcidFOLIC ACIDCardinal Health 107, LLC624469a1-ded9-453a-973e-c5a2f0602bb02026-05-15Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
Folic AcidFOLIC ACIDCardinal Health 107, LLC6dd867fe-597e-4915-8baf-98a605bf93242026-05-06Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
Folic AcidFOLIC ACIDBryant Ranch Prepacka1b71c5d-c842-43fd-9557-2bb4e934b9142026-04-23Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
Folic AcidFOLIC ACIDPreferred Pharmaceuticals Inc.b4c3a754-64cd-499a-a32f-a6e935c413552026-04-22Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
Folic AcidFOLIC ACIDAmneal Pharmaceuticals of New York LLCfd85395e-6a0b-4072-a80b-36095c0c6dd62026-04-15Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
MultitamFOLIC ACIDPureTek Corporationcee15842-4a9e-c6ba-e053-2a95a90aebc52026-04-13Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDXGen Pharmaceuticals DJB, Inc.c5b2b84d-9f5e-4b81-ba10-9f2854e5dce92026-01-21Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
Folic AcidFOLIC ACIDAphena Pharma Solutions - Tennessee, LLC40ab3c91-5a5b-fa1d-e063-6394a90a74542025-12-10Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
Folic AcidFOLIC ACIDAmerican Health Packagingfc6dc1e1-f63e-4239-a1eb-67525569f68c2025-11-13Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
Folic AcidFOLIC ACIDBryant Ranch Prepack4889d474-bd72-46ba-81d6-5511d8a85abb2025-11-04Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID
Folic AcidFOLIC ACIDBryant Ranch Prepack41914ac8-f4f5-4d70-b9f2-9f88c59d67a62025-10-29Warnings, Adverse reactionsName fallback
brand name: Folic Acid
generic name: FOLIC ACID

Reported adverse events (FAERS/openFDA)#

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