Antiseptic

Product NDC: 70000-0528
11-digit product format: 700000528
Labeler code: 70000
Product ID: 70000-0528_498e86aa-1db9-db53-e063-6294a90a7146
Type: HUMAN OTC DRUG
Nonproprietary name: Eucalyptol, Menthol, Methyl Salicylate, Thymol
Dosage form: MOUTHWASH
Route: ORAL
Labeler: Cardinal Health, 110 dba Leader
Application: 505G(a)(3)
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1997-06-15
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
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
70000-0528-1	Antiseptic	500 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	500		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0528-1	ML - Milliliter	70000-0528	2342268d-d17e-4052-a7eb-63690dcd0a6a	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70000-0528	ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [CARDINAL HEALTH, 110 DBA LEADER]	18	Current NDC, Legacy NDC, 1 package rows	20250507_d176eebb-4870-4206-a52e-f581ecaff400.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	d176eebb-4870-4206-a52e-f581ecaff400	19
1043619	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash	SCD	d176eebb-4870-4206-a52e-f581ecaff400	19
1043619	eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash	SY	d176eebb-4870-4206-a52e-f581ecaff400	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70000-0528-1	70000052801	500 mL in 1 BOTTLE, PLASTIC (70000-0528-1)	500 ml	1997-06-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Leader 664.003/664AU Blue Mint Antiseptic Mouthrinse	Cardinal Health, 110 dba Leader \| Nice-Pak Products, LLC	2026-01-29	HUMAN OTC DRUG LABEL	19