Antispetic

Product NDC
42507-963
11-digit product format
425070963
Labeler code
42507
Product ID
42507-963_4a04f150-daac-f153-e063-6394a90abebc
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, menthol, methyl salicylate, thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Hy-Vee, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-05
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
Antispetic
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3J50XA376EInternal UNII lookup
LAV5U5022YInternal UNII lookup
L7T10EIP3AInternal UNII lookup
RV6J6604TKInternal 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
4538029b-1ff9-080a-e063-6394a90ac9b7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42507-963-77Antispetic500 mL in 1 BOTTLE, PLASTICMOUTHWASH5002
42507-963-86Antispetic1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10002

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
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLHy-Vee, Inc.4538029b-1ff9-080a-e063-6394a90ac9b72026-02-04Warnings, Adverse reactionsExact identifier
ndc (product): 42507-963

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN4538029b-1ff9-080a-e063-6394a90ac9b72
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD4538029b-1ff9-080a-e063-6394a90ac9b72
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY4538029b-1ff9-080a-e063-6394a90ac9b72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42507-963-7742507096377500 mL in 1 BOTTLE, PLASTIC (42507-963-77) 500 ml2025-12-05NoNoCurrent
42507-963-86425070963861000 mL in 1 BOTTLE, PLASTIC (42507-963-86) 1000 ml2025-12-05NoNoCurrent