FDA.reportPublic FDA data

Antiseptic

Product NDC
55319-090
11-digit product format
553190090
Labeler code
55319
Product ID
55319-090_d32a10b2-84f7-45f7-9cf5-0259066bb0ab
Type
HUMAN OTC DRUG
Nonproprietary name
Eucalyptol, Menthol, Methyl Salicylate, Thymol
Dosage form
LIQUID
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-01
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
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 Identifiers#

Field, Values table
FieldValues
UniiRV6J6604TK, L7T10EIP3A, LAV5U5022Y, 3J50XA376E
Rxcui1043619

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-090-01Antiseptic1000 mL in 1 BOTTLE, PLASTICLIQUID10008
55319-090-15Antiseptic1500 mL in 1 BOTTLE, PLASTICLIQUID15008
55319-090-25Antiseptic250 mL in 1 BOTTLE, PLASTICLIQUID2508

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN269b9e7f-c5c8-4023-a3ea-e39040ade2718
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD269b9e7f-c5c8-4023-a3ea-e39040ade2718
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY269b9e7f-c5c8-4023-a3ea-e39040ade2718

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-090-01553190090011000 mL in 1 BOTTLE, PLASTIC (55319-090-01) 1000 ml2025-06-01NoNoCurrent
55319-090-15553190090151500 mL in 1 BOTTLE, PLASTIC (55319-090-15) 1500 ml2025-06-01NoNoCurrent
55319-090-2555319009025250 mL in 1 BOTTLE, PLASTIC (55319-090-25) 250 ml2025-06-01NoNoCurrent