FDA.reportPublic FDA data

Antispetic

Product NDC
37808-664
Requested package NDC
37808-664-69
11-digit product format
378080664
Labeler code
37808
Product ID
37808-664_5112432e-d1e4-f565-e063-6294a90a1916
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, menthol, methyl salicylate, thymol
Dosage form
MOUTHWASH
Route
ORAL
Labeler
H E B
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-05-19
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
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
d5fde535-1f74-4e82-af24-c88b324c1c52Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-664-12Antispetic1500 mL in 1 BOTTLE, PLASTICMOUTHWASH150018
37808-664-69Antispetic250 mL in 1 BOTTLE, PLASTICMOUTHWASH25018
37808-664-77Antispetic500 mL in 1 BOTTLE, PLASTICMOUTHWASH50018
37808-664-86Antispetic1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-664ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [H-E-B]16Current NDC, Legacy NDC, 4 package rows20250503_d5fde535-1f74-4e82-af24-c88b324c1c52.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
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLH E Bd5fde535-1f74-4e82-af24-c88b324c1c522026-05-05Warnings, Adverse reactionsExact identifier
ndc (package): 37808-664-69
ndc (product): 37808-664
ndc11 (package): 37808066469

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSNd5fde535-1f74-4e82-af24-c88b324c1c5218
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCDd5fde535-1f74-4e82-af24-c88b324c1c5218
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSYd5fde535-1f74-4e82-af24-c88b324c1c5218

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-664-6937808066469250 mL in 1 BOTTLE, PLASTIC (37808-664-69) 250 ml2009-05-190000-00-00NoNoCurrent