Antiseptic

Product NDC: 55319-290
11-digit product format: 553190290
Labeler code: 55319
Product ID: 55319-290_27dff864-d1dc-41f9-a312-d7d1aa66d7cc
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: 2027-12-31
Current FDA listing: Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Family Dollar (FAMILY WELLNESS)	f061ec82-7f0e-4b93-afa6-ae9fe14ab4ea	2026-04-01	Warnings	Exact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Do not use in children under 12 years of age. Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Keep out of reach of children under 6 years of age If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Additional Listing Data#

Finished product: Yes
Brand name base: Antiseptic
Listing expiration: 2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	RV6J6604TK, L7T10EIP3A, LAV5U5022Y, 3J50XA376E
Rxcui	1043619

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55319-290-01	Antiseptic	1000 mL in 1 BOTTLE, PLASTIC	LIQUID	1000		7
55319-290-25	Antiseptic	250 mL in 1 BOTTLE, PLASTIC	LIQUID	250		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55319-290	ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]	2	Current NDC, 2 package rows	20250402_f061ec82-7f0e-4b93-afa6-ae9fe14ab4ea.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RV6J6604TK	EUCALYPTOL	470-82-6	EUCALYPTOL
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE
3J50XA376E	THYMOL	89-83-8	THYMOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1043619	eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash	PSN	f061ec82-7f0e-4b93-afa6-ae9fe14ab4ea	7
1043619	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash	SCD	f061ec82-7f0e-4b93-afa6-ae9fe14ab4ea	7
1043619	eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash	SY	f061ec82-7f0e-4b93-afa6-ae9fe14ab4ea	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55319-290-01	55319029001	1000 mL in 1 BOTTLE, PLASTIC (55319-290-01)	1000 ml	2025-06-02	No	No	Current
55319-290-25	55319029025	250 mL in 1 BOTTLE, PLASTIC (55319-290-25)	250 ml	2025-06-02	No	No	Current