OroMin

Manufacturer
Germiphene Corporation
Effective date
2017-06-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:51:39

Label at a glance#

ProductOroMin
Active ingredientSODIUM PHOSPHATE, MONOBASIC, CALCIUM CHLORIDE, SODIUM FLUORIDE
Label structure8 sections

Dosage and administration

After brushing and flossing, rinse 10-15 mL of ORO Min (fill cap 3/4 full) between teeth for 60 seconds, then spit out. Do not swallow. Do not eat or drink for 30 minutes after rinsing. Use twice a day or as directed by your dentist or hygienist.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

ORO Min is a remineralizing and anti-cavity fluoride rinse. It provides essential minerals necessary to harden teeth and promote remineralizing of tooth surfaces.

Medicinal ingredient:

OTC - ACTIVE INGREDIENT SECTION

Calcium chloride 0.054%, sodium fluoride 0.02%, sodium phosphate 0.056%

Non-Medicinal Ingredients:

INACTIVE INGREDIENT SECTION

Water, ethyl alcohol, sorbitol solution, sodium chloride, edetate disodium, sodium benzoate, polysorbate 20, polysorbate 80, methyl paraben, sodium saccharin, propyl paraben, and flavouring agent.

Directions:

DOSAGE & ADMINISTRATION SECTION

After brushing and flossing, rinse 10-15 mL of ORO Min (fill cap 3/4 full) between teeth for 60 seconds, then spit out. Do not swallow. Do not eat or drink for 30 minutes after rinsing. Use twice a day or as directed by your dentist or hygienist.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

WARNINGS SECTION

Do not use if tamper-evident foil seal is broken. Do not store in direct sunlight.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 mL500 mL50 mL50 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1926055calcium chloride 0.054 % / sodium fluoride 0.02 % / sodium phosphate, monobasic 0.056 % MouthwashPSN1
1926055calcium chloride 0.54 MG/ML / sodium fluoride 0.2 MG/ML / sodium phosphate, monobasic 0.56 MG/ML MouthwashSCD1
1926055calcium chloride 0.054 % / sodium fluoride 0.02 % / sodium phosphate, monobasic 0.056 % MouthwashSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61508-0200-12020-01-31C16284748780-19d75b9d0-0862-f424-e053-dadaa90a57ceORO Min
61508-0200-22020-01-31C16284748780-19d75b9d0-0862-f424-e053-dadaa90a57ceORO Min

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61508-0200-1OroMin500 g in 1 BOTTLE, PLASTICRINSE5001
61508-0200-2OroMin50 g in 1 BOTTLE, PLASTICRINSE501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61508-0200OROMIN (CALCIUM CHLORIDE, SODIUM FLUORIDE, SODIUM PHOSPHATE) RINSE [GERMIPHENE CORPORATION]1Legacy NDC, 2 package rows20170616_51d8d5bd-baba-44c3-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61508-020061508-0200-1, 61508-0200-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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
51d8d5bd-babb-44c3-e054-00144ff88e8851d8d5bd-baba-44c3-e054-00144ff88e882017-06-13WarningsExact identifier
spl id: 51d8d5bd-babb-44c3-e054-00144ff88e88
spl set id: 51d8d5bd-baba-44c3-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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