FDA.reportPublic FDA data

Short Term Oral Care System

Manufacturer
Sage Products LLC
Effective date
2019-01-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:58:15

Label at a glance#

ProductShort Term Oral Care System
Active ingredientHYDROGEN PEROXIDE
Label structure9 sections

Dosage and administration

Use up to 4 times daily or as directed by a dentist or doctor. Adults and children 3 years and over: rinse mouth for approx. one minute with 1/2 Tbsp. Instruct to expectorate. Children under 12 yeras of age: supervise use. Children under 3 years of age: consult a dentist or doctor.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients for 6065Active Ingredients for 6065

Use

OTC - WHEN USING SECTION

Aids in the removal of secretions associated with sore mouth

Warnings

WARNINGS SECTION

Do not use:

  • For more than 7 days unless told to do so by a doctor.
  • Avoid Swallowing.

Stop use and ask a doctor if:

  • Sore mouth symptoms do not improve in 7 days.
  • Swelling, rash or fever develops.
  • Irritation, pain or redness persists or worsens.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If more than used for debriding is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

OTC - PURPOSE SECTION

  • Use up to 4 times daily or as directed by a dentist or doctor.
  • Adults and children 3 years and over: rinse mouth for approx. one minute with 1/2 Tbsp. Instruct to expectorate.
  • Children under 12 yeras of age: supervise use.
  • Children under 3 years of age: consult a dentist or doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, menthol flavor, polysorbate 80, phosphoric acid, sodium saccharin, Blue 1 (CI42090), Yellow 6 (CI15985)

Questions

OTC - QUESTIONS SECTION

Call toll free 800-323-2220

SPL UNCLASSIFIED SECTION

MADE IN U.S.A.

NOT MADE WITH NATURAL RUBBER LATEX

Short Term Oral Care System with Perox-A-Mint Solution

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Short term kit 6002DShort term kit 6002Dperoxamint 6065peroxamint 6065

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
358975hydrogen peroxide 1.5 % MouthwashPSN3
1866540Perox-A-Mint 1.5 % MouthwashPSN3
1866540hydrogen peroxide 15 MG/ML Mouthwash [Perox-A-Mint]SBD3
358975hydrogen peroxide 15 MG/ML MouthwashSCD3
358975hydrogen peroxide 1.5 % MouthwashSY3
1866540Perox-A-Mint 1.5 % MouthwashSY3
1866540Perox-A-Mint 15 MG/ML MouthwashSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53462-024-302021-01-29C16284748780-1ba0f9c33-5718-a910-e053-dadaa90a0b85Short Term Oral Care System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53462-024-30Short Term Oral Care System1 in 1 KITKIT13
53462-075-30Short Term Oral Care System44 mL in 1 BOTTLE, PLASTICMOUTHWASH44 mL15 mg in 1mL3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53462-024SHORT TERM ORAL CARE SYSTEM (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]3Legacy NDC, 2 package rows20190118_b6e3e97d-3f9a-4787-82d7-e992ade05974.zip
53462-075SHORT TERM ORAL CARE SYSTEM (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]3Current NDC, Legacy NDC20190118_b6e3e97d-3f9a-4787-82d7-e992ade05974.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53462-075-30ML - Milliliter53462-075beb020b4-a3b3-402a-afb9-4fd8e44bcf6f12013-11-04
53462-075-40ML - Milliliter53462-075dfa841fb-924e-4efb-bc49-688eeb1c471c12013-11-04

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53462-02453462-024-30
53462-07553462-075-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BICARBONATE8MDF5V39QOINGR
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311INGR
SODIUM LAURYL SULFATE368GB5141JINGR
SODIUM BENZOATEOJ245FE5EUINGR
WATER059QF0KO0RINGR
SACCHARIN SODIUMSB8ZUX40TYINGR
WATER059QF0KO0RIACT
PHOSPHORIC ACIDE4GA8884NNIACT
POLYSORBATE 806OZP39ZG8HIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYDROGEN PEROXIDEBBX060AN9VACTIB
COCONUT OILQ9L0O73W7LINGR
XYLITOLVCQ006KQ1EINGR
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311INGR
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0INGR
WATER059QF0KO0RINGR
POLYSORBATE 207T1F30V5YHINGR
POLYSORBATE 806OZP39ZG8HINGR
POTASSIUM SORBATE1VPU26JZZ4INGR
CETYLPYRIDINIUM CHLORIDED9OM4SK49PINGR
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31INGR
SPEARMINT OILC3M81465G5INGR

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Perox-A-Mint SolutionHYDROGEN PEROXIDESage Products, LLC50823ff5-ad08-4449-bc4a-9a8ae25ec0d52026-06-24WarningsExact identifier
ndc (package): 53462-075-30
ndc (product): 53462-075
ndc11 (package): 53462007530
7facde7d-b12d-798f-e053-2a91aa0a4751b6e3e97d-3f9a-4787-82d7-e992ade059742019-01-17WarningsExact identifier
spl id: 7facde7d-b12d-798f-e053-2a91aa0a4751
spl set id: b6e3e97d-3f9a-4787-82d7-e992ade05974

Reported adverse events (FAERS/openFDA)#

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