Antiseptic

Product NDC
55319-091
11-digit product format
553190091
Labeler code
55319
Product ID
55319-091_e1f080de-85ed-4945-8936-edcefce49fcb
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
2025-06-02
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
RV6J6604TKEUCALYPTOL470-82-6EUCALYPTOL
LAV5U5022YMETHYL SALICYLATE119-36-8METHYL SALICYLATE
3J50XA376ETHYMOL89-83-8THYMOL

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-091-01553190091011000 mL in 1 BOTTLE, PLASTIC (55319-091-01) 1000 ml2025-06-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Kalaya Breath Refresh Antiseptic Oral Rinse-updated label for NDCFamily Dollar (FAMILY WELLNESS)2025-11-03HUMAN OTC DRUG LABEL5
Kalaya Breath Refresh Antiseptic Oral Rinse-updated label for NDCFamily Dollar (FAMILY WELLNESS)2025-07-11HUMAN OTC DRUG LABEL4