FDA.reportPublic FDA data

Antiseptic Rinse Spring Mint

Product NDC
55319-972
11-digit product format
553190972
Labeler code
55319
Product ID
55319-972_4b931e41-3b62-4794-e063-6294a90aced8
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Menthol, Methyl salicylate, Thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Family Dollar Stores, Inc
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-05-12
Substance
EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL
Active strength
.92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Antiseptic Rinse Spring Mint
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EUCALYPTOL.92 mg/mL
MENTHOL.42 mg/mL
METHYL SALICYLATE.6 mg/mL
THYMOL.64 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RV6J6604TKInternal UNII lookup
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup
3J50XA376EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043619Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
974e97c5-a255-4bb4-9ec9-5edc3f7899ebAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-972-69Antiseptic Rinse Spring Mint250 mL in 1 BOTTLE, PLASTICMOUTHWASH25015
55319-972-86Antiseptic Rinse Spring Mint1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-972ANTISEPTIC RINSE SPRING MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [MIDWOOD BRANDS, LLC]14Current NDC, Legacy NDC, 2 package rows20250305_974e97c5-a255-4bb4-9ec9-5edc3f7899eb.zip

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 Rinse Spring MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar Stores, Inc974e97c5-a255-4bb4-9ec9-5edc3f7899eb2026-02-24Warnings, Adverse reactionsExact identifier
ndc (product): 55319-972

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN974e97c5-a255-4bb4-9ec9-5edc3f7899eb15
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD974e97c5-a255-4bb4-9ec9-5edc3f7899eb15
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY974e97c5-a255-4bb4-9ec9-5edc3f7899eb15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-972-6955319097269250 mL in 1 BOTTLE, PLASTIC (55319-972-69) 250 ml2014-05-120000-00-00NoNoCurrent
55319-972-86553190972861000 mL in 1 BOTTLE, PLASTIC (55319-972-86) 1000 ml2014-05-120000-00-00NoNoCurrent