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One Natal Rx

OneNatal RX Rx Prenatal Vitamin TabletIron with Prescription Folic AcidPrenatal & Postnatal

Approved
Approval ID

a4f80fca-e532-42a9-a6ae-125925cfb3f1

Product Type

DIETARY SUPPLEMENT

Effective Date

Aug 20, 2025

Manufacturers
FDA

AARNA USA INC

DUNS: 118515992

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Vitamin A, Ascorbic Acid, Cholecalciferol, DL-Alpha Tocopheryl Acetate, Thiamine Mononitrate, Vitamin B2, Niacinamide, Pyridoxine HCl, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, Cupric Oxide, Inositol, Citrus Bioflavonoids Fruit Complex, Boron Citrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82568-0141
Product Classification
G
Generic Name
Vitamin A, Ascorbic Acid, Cholecalciferol, DL-Alpha Tocopheryl Acetate, Thiamine Mononitrate, Vitamin B2, Niacinamide, Pyridoxine HCl, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, Cupric Oxide, Inositol, Citrus Bioflavonoids Fruit Complex, Boron Citrate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 20, 2025
FDA Product Classification

INGREDIENTS (27)

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL METHYLCELLULOSEInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
VITAMIN AActive
Quantity: 1200 ug in 1 1
Code: 81G40H8B0T
Classification: ACTIB
ASCORBIC ACIDActive
Quantity: 120 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
VITAMIN DActive
Quantity: 10 ug in 1 1
Code: 9VU1KI44GP
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-Active
Quantity: 9.2 mg in 1 1
Code: WR1WPI7EW8
Classification: ACTIM
THIAMINEActive
Quantity: 1.84 mg in 1 1
Code: X66NSO3N35
Classification: ACTIB
RIBOFLAVINActive
Quantity: 3 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
NIACINAMIDEActive
Quantity: 20 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIM
FOLIC ACIDActive
Quantity: 1666.67 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 12 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
CALCIUM CARBONATEActive
Quantity: 200 mg in 1 1
Code: H0G9379FGK
Classification: ACTIM
FERROUS FUMARATEActive
Quantity: 27 mg in 1 1
Code: R5L488RY0Q
Classification: ACTIM
ZINC OXIDEActive
Quantity: 25 mg in 1 1
Code: SOI2LOH54Z
Classification: ACTIM
CUPRIC OXIDEActive
Quantity: 2 mg in 1 1
Code: V1XJQ704R4
Classification: ACTIM
INOSITOLActive
Quantity: 5 mg in 1 1
Code: 4L6452S749
Classification: ACTIB
CITRUS BIOFLAVONOIDSActive
Quantity: 2 mg in 1 1
Code: BD70459I50
Classification: ACTIB
BORON CITRATEActive
Quantity: 0.2 mg in 1 1
Code: S043P4DV22
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/20/2025

label

STATEMENT OF IDENTITY SECTION

LOINC: 69718-5Updated: 8/20/2025

HEALTH CLAIM SECTION

LOINC: 69719-3Updated: 8/20/2025

Supplement Facts

Serving Size: 1 Tablet

Servings Per Container: 90

Amount Per Tablet

% Daily Value Pregnant & Lactating Women

Vitamin A (as Beta Carotene and Retinyl Acetate)

1200 mcg

92%

Vitamin C (Ascorbic Acid)

120 mg

100%

Vitamin D (as Cholecalciferol)

10 mcg

67%

Vitamin E (as DL-Alpha Tocopheryl Acetate)

9.2 mg

48%

Thiamin (Vitamin B1) (as Thiamine Mononitrate)

1.84 mg

131%

Riboflavin (Vitamin B2)

3 mg

188%

Niacin (as Niacinamide)

20 mg

111%

Vitamin B6 (as Pyridoxine HCl)

10 mg

500%

Folate

1,666.67 mcg DFE
(1000 mcg Folic Acid)

278%

Vitamin B12 (as Cyanocobalamin)

12 mcg

429%

Calcium (as Calcium Carbonate)

200 mg

15%

Iron (as Ferrous Fumarate)

27 mg

100%

Zinc (as Zinc Oxide)

25 mg

192%

Copper (as Cupric Oxide)

2 mg

154%

Inositol

5 mg

Citrus Bioflavonoids Fruit Complex

2 mg

Boron (as Boron Citrate)

0.2 mg

† Daily Value not established.

Other Ingredients: Microcrystalline Cellulose, Stearic Acid, Magnesium Stearate, Croscarmellose Sodium, Silicon Dioxide, Coating (Hydroxypropyl Methylcellulose, Polyethylene Glycol, FD&C Red #40 (Lake), FD&C Blue #2 (Lake), FD&C Yellow #5(Lake)).

Description:

One Natal RX Tablet is an orally administered prenatal/postnatal prescription folic acid-containing dietary supplement and should be administered under the supervision of a licensed medical practitioner.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/20/2025

DOSAGE AND ADMINISTRATION:

Before, during and/or after pregnancy, one tablet daily, with a meal, or as directed by a licensed healthcare practitioner regardless of lactation status.

WARNINGS SECTION

LOINC: 34071-1Updated: 8/20/2025

WARNING:

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

SAFE HANDLING WARNING SECTION

LOINC: 50741-8Updated: 8/20/2025

CAUTION:

High levels of folic acid may, especially in older adults, hide signs of Vitamin B-12 deficiency (such as pernicious anemia), a condition that can cause nerve damage.

Store at 15°-30° C (59°-86° F). Protect from light and moisture. Dispense in a tight, light-resistant container. Notice: Contact with moisture may produce surface discoloration or erosion.

Call your licensed medical practitioner about side effect. You may report side effects by calling1-877-225-6999.

Manufactured for:

AARNA USA Inc.

Leland, NC 28451

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