Antiseptic Mouth Rinse

Product NDC: 11344-072
11-digit product format: 113440072
Labeler code: 11344
Product ID: 11344-072_4cd61b41-1725-2025-e063-6294a90aa2de
Type: HUMAN OTC DRUG
Nonproprietary name: Eucalyptol, Menthol, Methyl Salicylate, Thymol
Dosage form: MOUTHWASH
Route: ORAL
Labeler: Nice-Pak Products, LLC
Application: 505G(a)(3)
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2009-08-15
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 Mouth Rinse
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11344-072-69	2024-03-14	C162847	48780-1	9d75b9d0-2a3d-f424-e053-dadaa90a57ce	Swan 072.003/072AL rev 2 - AN Spring Mint Antiseptic Mouthrinse
11344-072-86	2024-03-14	C162847	48780-1	9d75b9d0-2a3d-f424-e053-dadaa90a57ce	Swan 072.003/072AL rev 2 - AN Spring Mint Antiseptic Mouthrinse
11344-072-69	2020-01-31	C162847	48780-1	9d75b9d0-2a3d-f424-e053-dadaa90a57ce	Swan 072.003/072AL rev 2 - AN Spring Mint Antiseptic Mouthrinse
11344-072-86	2020-01-31	C162847	48780-1	9d75b9d0-2a3d-f424-e053-dadaa90a57ce	Swan 072.003/072AL rev 2 - AN Spring Mint Antiseptic Mouthrinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11344-072-69	Antiseptic Mouth Rinse	250 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	250		5
11344-072-77	Antiseptic Mouth Rinse	500 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	500		5
11344-072-86	Antiseptic Mouth Rinse	1000 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	1000		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
EUCALYPTOL	ACTIVE INGREDIENT	RV6J6604TK	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [VI JON]	1
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [VI JON]	1
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [VI JON]	1
THYMOL	ACTIVE INGREDIENT	3J50XA376E	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [VI JON]	1
EUCALYPTOL	ACTIVE MOIETY	RV6J6604TK	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [VI JON]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [VI JON]	1
METHYL SALICYLATE	ACTIVE MOIETY	LAV5U5022Y	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [VI JON]	1
THYMOL	ACTIVE MOIETY	3J50XA376E	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [VI JON]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [VI JON]	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [VI JON]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [VI JON]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [VI JON]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11344-072	ANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [CONSUMER PRODUCT PARTNERS, LLC]	4	Current NDC, Legacy NDC, 3 package rows	20250322_b60be9d4-cf1c-4d4d-b15b-20630b0a4be4.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	b60be9d4-cf1c-4d4d-b15b-20630b0a4be4	5
1043619	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash	SCD	b60be9d4-cf1c-4d4d-b15b-20630b0a4be4	5
1043619	eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash	SY	b60be9d4-cf1c-4d4d-b15b-20630b0a4be4	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
11344-072-69	11344007269	250 mL in 1 BOTTLE, PLASTIC (11344-072-69)	250 ml	2009-08-15	No	No	Historical
11344-072-77	11344007277	500 mL in 1 BOTTLE, PLASTIC (11344-072-77)	500 ml	2009-08-15	No	No	Historical
11344-072-86	11344007286	1000 mL in 1 BOTTLE, PLASTIC (11344-072-86)	1000 ml	2009-08-15	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Swan 072.003/072AL rev 2 - AN Spring Mint Antiseptic Mouthrinse	Nice-Pak Products, LLC	2026-03-12	HUMAN OTC DRUG LABEL	5