FDA.reportPublic FDA data

Dioscorea batata 16X

Manufacturer
Uriel Pharmacy Inc.
Effective date
2024-03-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:26:18

Label at a glance#

ProductDioscorea batata 16X
Active ingredientCHINESE YAM
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

Dissolve pellets under the tongue 3-4 times daily. Ages 12 and older: 10 pellets. Ages 2-11: 5 pellets. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Dioscorea batata (Chinese yam) 16X

INACTIVE INGREDIENT SECTION

Inactive Ingredient: Organic sucrose

"prepared using rhythmical processes"

OTC - PURPOSE SECTION

Use: Temporary relief of headache.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Contains sugar. Diabetics and persons intolerant of sucrose (sugar): Consult a doctor before use. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858 Uriel, East Troy, WI 53120 shopuriel.com Lot:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dioscorea batata 16X PelletsDioscorea batata 16X Pellets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-4185-2Dioscorea batata 16X1350 in 1 BOTTLE, GLASSPELLET13501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-4185DIOSCOREA BATATA 16X PELLET [URIEL PHARMACY INC.]11 package rows20240312_130222de-272f-7694-e063-6294a90a4d70.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-418548951-4185-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHINESE YAM29CIF30B1ZACTIB
SUCROSEC151H8M554IACT

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
130222de-2730-7694-e063-6294a90a4d70130222de-272f-7694-e063-6294a90a4d702024-03-06WarningsExact identifier
spl id: 130222de-2730-7694-e063-6294a90a4d70
spl set id: 130222de-272f-7694-e063-6294a90a4d70

Reported adverse events (FAERS/openFDA)#

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