FDA.reportPublic FDA data

Hendel Periodontal and Tooth Pain Relief

Manufacturer
MediNatura Inc
Effective date
2022-08-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:18:04

Label at a glance#

ProductHendel Periodontal and Tooth Pain Relief
Active ingredientSODIUM BORATE, TRIBASIC CALCIUM PHOSPHATE, MERCURIUS SOLUBILIS, SILICON DIOXIDE
Label structure7 sections

Indications and uses

For the temporary relief of: • Sore gums • Toothache • Bad breath

Dosage and administration

Dosage: Adults 18 and over: 1 tablet sublingually or dissolved completely in mouth 2 to 3 times per day or as directed by a physician.

Label contents#

Full prescribing information#

WARNINGS

WARNINGS SECTION

WARNINGS: If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Stop use and ask doctor if symptoms do not improve in 7 days or if swelling or fever develops or if irritation, pain or redness persist or worsens.

Do not use if sensitivity to Periodontal & Tooth Pain Relief or any of its ingredients exists. In case of accidental overdose, contact a Poison Control Center immediately.

PURPOSE

OTC - PURPOSE SECTION

Periodontal & Tooth Pain Relief

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

USES

INDICATIONS & USAGE SECTION

For the temporary relief of:

• Sore gums
• Toothache
• Bad breath

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Each tablet contains equal parts of Borax 8X; Calcarea phosphorica 12X; Mercurius solubilis 12X; Silicea 12X

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Lactose, Magnesium stearate

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Dosage: Adults 18 and over: 1 tablet sublingually or dissolved completely in mouth 2 to 3 times per day or as directed by a physician.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionHendel Periodontal and Tooth Pain Reliefimage descriptionHendel Periodontal and Tooth Pain Relief

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DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62795-1133-2Hendel Periodontal and Tooth Pain Relief100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62795-1133HENDEL PERIODONTAL AND TOOTH PAIN RELIEF (SODIUM BORATE, TRIBASIC CALCIUM PHOSPHATE, MERCURIUS SOLUBILIS, AND SILICON DIOXIDE) TABLET [MEDINATURA INC]2Current NDC, Legacy NDC, 1 package rows20220823_f34e9f77-69fd-4c7f-9eea-2d721a4d27fb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62795-1133-2EA - Each62795-1133a5e9ec1a-cbd3-4f83-8cbc-8074114f4e5312022-07-06

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62795-113362795-1133-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BORATE91MBZ8H3QOACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
MERCURIUS SOLUBILIS324Y4038G2ACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT

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
Hendel Periodontal and Tooth Pain ReliefSODIUM BORATE, TRIBASIC CALCIUM PHOSPHATE, MERCURIUS SOLUBILIS, AND SILICON DIOXIDEMediNatura Incf34e9f77-69fd-4c7f-9eea-2d721a4d27fb2022-08-22WarningsExact identifier
ndc (package): 62795-1133-2
ndc (product): 62795-1133
ndc11 (package): 62795113302
spl id: 236170c9-286a-4ec1-901f-b9eb77d24e59
spl set id: f34e9f77-69fd-4c7f-9eea-2d721a4d27fb

Reported adverse events (FAERS/openFDA)#

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