FDA.reportPublic FDA data

Borax

Manufacturer
SEVENE USA
Effective date
2025-02-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:31:57

Label at a glance#

ProductBorax 200ck
Active ingredientSODIUM BORATE
Label structure13 sections

Dosage and administration

(adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a physician.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

HOMEOPATHIC DILUTION OF HPUS Borax 200ck **C, K, CK, AND X ARE HOMEOPATHIC DILUTIONS

TRADITIONALLY USED FOR:

OTC - PURPOSE SECTION

Canker sores (mouth ulcers)*

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

(adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a physician.

USE:

INDICATIONS & USAGE SECTION

Condition listed above or as directed by a physician.

WARNINGS:

WARNINGS SECTION

Stop use and ask a physician if symptoms persist for more than 3 days or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTHER INFORMATION:

OTHER SAFETY INFORMATION

Store at room temperature.

OTC - DO NOT USE SECTION

Do not use if pellet-dispenser seal is broken.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Sucrose.

QUESTIONS?

OTC - QUESTIONS SECTION

INFO@OLLOIS.COM * WWW.OLLOIS.COM * MADE IN FRANCE. NOT REVIEWED BY THE FDA AND NOT GUARANTEED TO BE EFFECTIVE. THIS HOMEOPATHIC DILUTION MAY NOT BE SUSEPTIBLE TO SCIENTIFIC MEASUREMENT.

USE:

RECENT MAJOR CHANGES SECTION

Condition listed above or as directed by a physician.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BORAX 200CKBORAX 200CKBORAX 200CKBORAX 200CKBORAX 200CKBORAX 200CK

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76472-3006-12025-02-10C16284748780-12cef2736-6d08-d83d-e063-dadaa90ab31fSevene USA (as PLD) - BORAX 200ck (76472-3006)
76472-3006-12025-01-30C16284748780-12cef2736-6d08-d83d-e063-dadaa90ab31fSevene USA (as PLD) - BORAX 200ck (76472-3006)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76472-3006-1Borax200ck80 in 1 CYLINDERPELLET804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76472-3006BORAX 200CK (SODIUM BORATE) PELLET [SEVENE USA]4Current NDC, Legacy NDC, 1 package rows20250212_c8d359b2-3ba0-3117-e053-2a95a90aac2f.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76472-300676472-3006-1

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
SUCROSEC151H8M554IACT
SODIUM BORATE91MBZ8H3QOACTIB

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
Borax 200ckSODIUM BORATESEVENE USAc8d359b2-3ba0-3117-e053-2a95a90aac2f2025-02-10WarningsExact identifier
ndc (package): 76472-3006-1
ndc (product): 76472-3006
ndc11 (package): 76472300601
spl id: 2dcc6b58-7a86-e2ac-e063-6294a90a9262
spl set id: c8d359b2-3ba0-3117-e053-2a95a90aac2f

Reported adverse events (FAERS/openFDA)#

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