Antispetic

Product NDC: 0869-0664
Requested package NDC: 0869-0664-12
11-digit product format: 008690664
Labeler code: 0869
Product ID: 0869-0664_dbdda171-f790-463e-b867-5d83c84d62b9
Type: HUMAN OTC DRUG
Nonproprietary name: Eucalyptol, menthol, methyl salicylate, thymol
Dosage form: MOUTHWASH
Route: ORAL
Labeler: Vi-Jon, LLC
Application: part356
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 1992-07-15
Marketing end: 0000-00-00
Substance: EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL
Active strength: 1 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0869-0664	0869-0664-12	D	Discontinued by firm		2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	SPL version
0869-0664-12	Antispetic	1500 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	1500	17
0869-0664-13	Antispetic	1250 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	1250	17
0869-0664-19	Antispetic	94 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	94	17
0869-0664-69	Antispetic	250 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	250	17
0869-0664-77	Antispetic	500 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	500	17
0869-0664-86	Antispetic	1000 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	1000	17
0869-0664-88	Antispetic	2000 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	2000	17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
EUCALYPTOL	ACTIVE INGREDIENT	RV6J6604TK	ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]	1
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]	1
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]	1
THYMOL	ACTIVE INGREDIENT	3J50XA376E	ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]	1
EUCALYPTOL	ACTIVE MOIETY	RV6J6604TK	ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]	1
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]	1
THYMOL	ACTIVE MOIETY	3J50XA376E	ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0869-0664	ANTISPETIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [VI-JON, LLC]	16	Legacy NDC, 7 package rows	20250514_8bdbfc38-7c14-4162-8d5f-c0bbb7765ea1.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	8bdbfc38-7c14-4162-8d5f-c0bbb7765ea1	17
1043619	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash	SCD	8bdbfc38-7c14-4162-8d5f-c0bbb7765ea1	17
1043619	eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash	SY	8bdbfc38-7c14-4162-8d5f-c0bbb7765ea1	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0869-0664-12	00869066412	1250 mL in 1 BOTTLE, PLASTIC (0869-0664-12)	1250 ml	1992-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Swan 664.003/664AT rev2-AU Blue Mint Antiseptic Mouthrinse	Vi-Jon, LLC \| Nice-Pak Products, LLC	2026-03-12	HUMAN OTC DRUG LABEL	17