FDA.reportPublic FDA data

Antiseptic

Manufacturer
Lil' Drug Store Products, Inc
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:50:13

Label at a glance#

ProductAntiseptic Lil Drug Store Products
Active ingredientEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, THYMOL
Label structure9 sections

Dosage and administration

adults and children 12 years of age and older vigorously swish 20 milliliters of rinse between teeth twice a day for 30 seconds then spit out. Do not swallow the rinse. children 6 to 12 years of age supervise use children under 6 years of age do not use

Storage and handling

not intended to replace brushing or flossing store at room temperature (59°-77°F). cold weather may cloud this product, but will not affect its antiseptic properties.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Eucalyptol 0.092%, Menthol 0.042%Antigingivitis, Antiplaque
Methyl salicylate 0.060%, Thymol 0.064%Antigingivitis, Antiplaque

Use

INDICATIONS & USAGE SECTION

Helps reduce plaque that leads to

  • gingivitis
  • bleeding gums

Warnings

WARNINGS SECTION

Stop use and see your dentist immediately if

OTC - STOP USE SECTION

  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing space between the teeth.

These may be signs or symptoms of periodontitis, a serious form of gum disease.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and oldervigorously swish 20 milliliters of rinse between teeth twice a day for 30 seconds then spit out. Do not swallow the rinse.
children 6 to 12 years of agesupervise use
children under 6 years of agedo not use

Other information

STORAGE AND HANDLING SECTION

  • not intended to replace brushing or flossing
  • store at room temperature (59°-77°F).
  • cold weather may cloud this product, but will not affect its antiseptic properties.

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol (21.6%), benzoic acid, flavor, green 3, polaxamer 407, sodium benzoate, sodium saccharin, sorbitol, water

SPL UNCLASSIFIED SECTION

Distributed by:
Lil' Drug Store Products, Inc.
9300 Earhart Lane SW
Cedar Rapids, IA 52404

PRINCIPAL DISPLAY PANEL - 251 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITY
⋆ GUARANTEED ⋆

Compare to the Active Ingredients
in Listerine ® Cool Mint ®*

Blue Mint

Antiseptic
Mouthwash
Antigingivitis/Antiplaque

Helps remove germs that cause
• Bad Breath • Plaque • Gingivitis

8.5 FL OZ (251 mL)

Lil'
Drug Store ®

PRINCIPAL DISPLAY PANEL - 251 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 251 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN6
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD6
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-6861-4AntisepticLil Drug Store Products250 mL in 1 BOTTLELIQUID2506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6861ANTISEPTIC LIL DRUG STORE PRODUCTS (EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL) LIQUID [LIL' DRUG STORE PRODUCTS, INC]6Current NDC, Legacy NDC, 1 package rows20250101_dca36a30-2c9f-4d0b-be88-b45c7046f509.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
EucalyptolACTIVE INGREDIENTRV6J6604TK1
Menthol, Unspecified FormACTIVE INGREDIENTL7T10EIP3A1
Methyl salicylateACTIVE INGREDIENTLAV5U5022Y1
ThymolACTIVE INGREDIENT3J50XA376E1
EucalyptolACTIVE MOIETYRV6J6604TK1
Menthol, Unspecified FormACTIVE MOIETYL7T10EIP3A1
Salicylic AcidACTIVE MOIETYO414PZ4LPZ1
ThymolACTIVE MOIETY3J50XA376E1
AlcoholINACTIVE INGREDIENT3K9958V90M1
Benzoic acidINACTIVE INGREDIENT8SKN0B0MIM1
FD&C Green no. 3INACTIVE INGREDIENT3P3ONR6O1S1
Poloxamer 407INACTIVE INGREDIENTTUF2IVW3M21
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TY1
Sodium benzoateINACTIVE INGREDIENTOJ245FE5EU1
SorbitolINACTIVE INGREDIENT506T60A25R1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66715-686166715-6861-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
SORBITOL506T60A25RIACT
POLOXAMER 407TUF2IVW3M2IACT
BENZOIC ACID8SKN0B0MIMIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
FD&C GREEN NO. 33P3ONR6O1SIACT
EUCALYPTOLRV6J6604TKACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
THYMOL3J50XA376EACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 82 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Poloxamer 407POLOXAMER 407TUF2IVW3M2POWDER, FOR SUSPENSION / ORAL0.01 mgExact identifier — unii+route
14 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2CAPSULE, EXTENDED RELEASE / ORAL40 mgExact identifier — unii+route
14 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii+route
38 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C Green no. 3FD&C GREEN NO. 33P3ONR6O1STABLET, COATED / ORAL0.01 mgExact identifier — unii+route
22 equally ranked IID candidates
FD&C Green no. 3FD&C GREEN NO. 33P3ONR6O1SSOLUTION / ORAL0.25 mg/5mlExact identifier — unii+route
22 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUTABLET, DELAYED RELEASE / ORAL0.34 mgExact identifier — unii+route
38 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2TABLET / ORAL495 mgExact identifier — unii+route
14 equally ranked IID candidates
FD&C Green no. 3FD&C GREEN NO. 33P3ONR6O1STABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2TABLET / ORAL495 mgExact identifier — unii+route
14 equally ranked IID candidates
FD&C Green no. 3FD&C GREEN NO. 33P3ONR6O1STABLET / ORAL240 mgExact identifier — unii+route
22 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUPOWDER, FOR SOLUTION / ORAL98 mgExact identifier — unii+route
38 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii+route
38 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii+route
38 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C Green no. 3FD&C GREEN NO. 33P3ONR6O1STABLET / ORAL240 mgExact identifier — unii+route
22 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2CAPSULE, DELAYED RELEASE / ORAL5 mgExact identifier — unii+route
14 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii+route
38 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route
38 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C Green no. 3FD&C GREEN NO. 33P3ONR6O1SCAPSULE, EXTENDED RELEASE / ORAL0.16 mgExact identifier — unii+route
22 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii+route
38 equally ranked IID candidates
FD&C Green no. 3FD&C GREEN NO. 33P3ONR6O1SCAPSULE, EXTENDED RELEASE / ORAL0.16 mgExact identifier — unii+route
22 equally ranked IID candidates
Benzoic acidBENZOIC ACID8SKN0B0MIMLIQUID / ORAL2 mg/1mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUPOWDER, FOR SUSPENSION / ORAL160 mgExact identifier — unii+route
38 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii+route
38 equally ranked IID candidates
SorbitolSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route
38 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C Green no. 3FD&C GREEN NO. 33P3ONR6O1SCAPSULE, COATED PELLETS / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2POWDER, FOR SUSPENSION / ORAL0.01 mgExact identifier — unii+route
14 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C Green no. 3FD&C GREEN NO. 33P3ONR6O1SCAPSULE, DELAYED RELEASE / ORAL5 mgExact identifier — unii+route
22 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii+route
38 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii+route
38 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii+route
38 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route
38 equally ranked IID candidates
SorbitolSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii+route
38 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUGRANULE / ORALNAExact identifier — unii+route
38 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C Green no. 3FD&C GREEN NO. 33P3ONR6O1SELIXIR / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii+route
38 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii+route
38 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2CAPSULE, EXTENDED RELEASE / ORAL40 mgExact identifier — unii+route
14 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2CAPSULE / ORAL468 mgExact identifier — unii+route
14 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii+route
38 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii+route
38 equally ranked IID candidates
FD&C Green no. 3FD&C GREEN NO. 33P3ONR6O1SSYRUP / ORAL3.75 mg/5mlExact identifier — unii+route
22 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route
38 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii+route
38 equally ranked IID candidates
Benzoic acidBENZOIC ACID8SKN0B0MIMLIQUID / ORAL2 mg/1mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C Green no. 3FD&C GREEN NO. 33P3ONR6O1SCAPSULE / ORAL40 mgExact identifier — unii+route
22 equally ranked IID candidates
FD&C Green no. 3FD&C GREEN NO. 33P3ONR6O1SCAPSULE, COATED PELLETS / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
FD&C Green no. 3FD&C GREEN NO. 33P3ONR6O1SSYRUP / ORAL3.75 mg/5mlExact identifier — unii+route
22 equally ranked IID candidates
Sodium benzoateSODIUM BENZOATEOJ245FE5EUTABLET, DELAYED RELEASE / ORAL0.34 mgExact identifier — unii+route
38 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2SOLUTION / ORAL50 mg/5mlExact identifier — unii+route
14 equally ranked IID candidates
Poloxamer 407POLOXAMER 407TUF2IVW3M2SOLUTION / ORAL50 mg/5mlExact identifier — unii+route
14 equally ranked IID candidates

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
Antiseptic Lil Drug Store ProductsEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLLil' Drug Store Products, Incdca36a30-2c9f-4d0b-be88-b45c7046f5092024-12-31WarningsExact identifier
ndc (package): 66715-6861-4
ndc (product): 66715-6861
ndc11 (package): 66715686104
spl id: 2a925329-8e0d-7711-e063-6394a90afa34
spl set id: dca36a30-2c9f-4d0b-be88-b45c7046f509

Reported adverse events (FAERS/openFDA)#

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