Antiseptic Mouth Rinse

Product NDC: 36800-072
11-digit product format: 368000072
Labeler code: 36800
Product ID: 36800-072_4ab7ce2e-b288-955d-e063-6294a90a3a44
Type: HUMAN OTC DRUG
Nonproprietary name: Eucalyptol, Menthol, Methyol salicylate, Thymol
Dosage form: MOUTHWASH
Route: ORAL
Labeler: Topco Associates LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1995-07-07
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

Reported adverse events (FAERS/openFDA)#

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

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 UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
RV6J6604TK	Internal UNII lookup
L7T10EIP3A	Internal UNII lookup
LAV5U5022Y	Internal UNII lookup
3J50XA376E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1043619	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a38e91c1-7ac6-4a7f-a5a2-8d9166b1535a	Available on FDA.report

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
36800-072-12	Antiseptic Mouth Rinse	1500 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	1500	15
36800-072-77	Antiseptic Mouth Rinse	500 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	500	15
36800-072-86	Antiseptic Mouth Rinse	1000 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	1000	15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
EUCALYPTOL	ACTIVE INGREDIENT	RV6J6604TK	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
THYMOL	ACTIVE INGREDIENT	3J50XA376E	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
EUCALYPTOL	ACTIVE MOIETY	RV6J6604TK	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
METHYL SALICYLATE	ACTIVE MOIETY	LAV5U5022Y	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
THYMOL	ACTIVE MOIETY	3J50XA376E	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ANTISEPTIC MOUTH RINSE (EUCALYPTOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-072	ANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYOL SALICYLATE, THYMOL) MOUTHWASH [TOPCO ASSOCIATES, LLC]	14	Current NDC, Legacy NDC, 3 package rows	20250529_a38e91c1-7ac6-4a7f-a5a2-8d9166b1535a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 142 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tact Cool Jelly	DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL	Sato Pharmaceutical Co., Ltd.	f34872c9-91b9-49db-8e41-5b54a069284a	2023-12-01	Warnings	Exact identifier application number: M017
Satohap	METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL	Sato Pharmaceutical Co., Ltd.	348fde05-2797-4410-a1b2-99e64187c4fe	2023-12-01	Warnings	Exact identifier application number: M017
Menthozen Hydrogel	MENTHOL, CAPSAICIN	Proficient Rx LP	85a7809e-c43f-4138-a85b-44e1b586def5	2023-12-01	Warnings	Exact identifier application number: M017
Menthozen Cream	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Proficient Rx LP	66681906-c5f5-4c57-bb43-9c83cccc0062	2023-12-01	Warnings	Exact identifier application number: M017
Lidozen Patch	LIDOCAINE, MENTHOL	Proficient Rx LP	c0df4b8b-2679-4652-9144-a8db916a186b	2023-12-01	Warnings	Exact identifier application number: M017
Lidozen Gel	LIDOCAINE HYDROCHLORIDE, MENTHOL	Proficient Rx LP	7c300dec-cefd-4b79-a948-a917b7708a04	2023-12-01	Warnings	Exact identifier application number: M017
Menthozen	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Proficient Rx LP	2adf3c4d-636f-4e02-b501-946b4df5f5d6	2023-12-01	Warnings	Exact identifier application number: M017
Lidozen	LIDOCAINE, MENTHOL	Proficient Rx LP	488d665c-a4fe-4a69-bab3-34b2347f4b05	2023-12-01	Warnings	Exact identifier application number: M017
Thera Plus Max Strength Lidocaine Pain Relief Liquid	LIDOCAINE HYDROCHLORIDE	Fourstar Group USA, Inc.	0a228b06-0e1c-6c75-e063-6294a90a9a0e	2023-11-30	Warnings	Exact identifier application number: M017
Thera Plus Cool and Heat Pain Relieving Gel Menthol	MENTHOL	Fourstar Group USA, Inc.	0a225714-ccb1-4676-e063-6294a90aeeb2	2023-11-30	Warnings	Exact identifier application number: M017
Bloop Itch Soothing Topical	HYDROCORTISONE	Three Nations Corp	0b64677e-d4bf-0929-e063-6294a90af137	2023-11-30	Warnings	Exact identifier application number: M017
Ice Quake	MENTHOL	Southern Sales & Service, Inc.	7a05832f-49ac-4013-b240-4405501e45cd	2023-11-29	Warnings	Exact identifier application number: M017
ICE MUSCLE RUB Leon M.C	MENTHOL	Southern Sales & Service, Inc.	4efaf347-7406-4690-8005-e7cf2e3d4222	2023-11-29	Warnings	Exact identifier application number: M017
IceQuake Analgestic White	METHYL SALICYLATE, MENTHOL	Southern Sales & Service, Inc.	54e5dcd5-9987-488d-a758-d0e76d155182	2023-11-29	Warnings	Exact identifier application number: M017
Icequake Coldn Hot medicated patch	MENTHOL	Southern Sales & Service, Inc.	89202c52-9eb7-4e5a-a709-4a66ab0d3a72	2023-11-29	Warnings	Exact identifier application number: M017
IceQuake Lidocaine Analgesic	LIDOCAINE HYDROCHLORIDE	Southern Sales & Service, Inc.	9089cb78-e9f8-4437-a767-df809a114c4b	2023-11-29	Warnings	Exact identifier application number: M017
Ice Quake Muscle Rub Blue	MENTHOL	Southern Sales & Service, Inc.	5180f6a3-58f1-4c50-a33b-7d85a3c1b99b	2023-11-29	Warnings	Exact identifier application number: M017
Discount Drug Mart Extra Strength Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Discount Drug Mart	8579df23-ac07-9df8-e053-2991aa0a8bbb	2023-11-29	Warnings	Exact identifier application number: M017
Satohap	METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL	Sato Pharmaceutical Co., Ltd.	3a2fc8ae-f1ac-4c64-8e75-d5fdb141aecf	2023-11-28	Warnings	Exact identifier application number: M017
Poli-A	HYDROCORTISONE ACETATE	Sato Pharmaceutical Co., Ltd.	e27a3840-d9de-4bd0-ad75-8a151bd12b83	2023-11-28	Warnings	Exact identifier application number: M017

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	a38e91c1-7ac6-4a7f-a5a2-8d9166b1535a	15
1043619	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash	SCD	a38e91c1-7ac6-4a7f-a5a2-8d9166b1535a	15
1043619	eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash	SY	a38e91c1-7ac6-4a7f-a5a2-8d9166b1535a	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-072-12	36800007212	1500 mL in 1 BOTTLE, PLASTIC (36800-072-12)	1500 ml	1995-07-07	0000-00-00	No	No	Current
36800-072-77	36800007277	500 mL in 1 BOTTLE, PLASTIC (36800-072-77)	500 ml	1995-07-07	0000-00-00	No	No	Current
36800-072-86	36800007286	1000 mL in 1 BOTTLE, PLASTIC (36800-072-86)	1000 ml	1995-07-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Top Care 072.003/072AN Spring Mint Antiseptic Mouthrinse	Topco Associates LLC \| Nice-Pak Products, LLC	2026-02-13	HUMAN OTC DRUG LABEL	15