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 150 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Biofreeze Roll-On	MENTHOL	A-S Medication Solutions	814b37ea-5441-4cec-8794-71ca01d849ae	2023-10-30	Warnings	Exact identifier application number: M017
Dr. Sheffield Hydrocortisone Anti itch	HYDROCORTISONE	Sheffield Pharmaceuticals LLC	71c9f2f4-2188-45eb-b55e-3856ac78070b	2023-10-30	Warnings	Exact identifier application number: M017
Family Wellness	BENZOCAINE, RESORCINOL	Zhejiang Jingwei Pharmaceutic Al Co., Ltd.	df540eb8-6773-4647-9cc2-c3fd14d7355e	2023-10-27	Warnings	Exact identifier application number: M017
Family Wellness	HYDROCORTISONE 1%	FRONT PHARMACEUTICAL PLC	ea26265d-f24e-458e-8bf0-287b2d49f4f4	2023-10-27	Warnings	Exact identifier application number: M017
Joint Formula 88 MAX PLUS	CAMPHOR	Sarati International, Inc.	f5d78335-b78d-4909-a88b-9daa3c18ba15	2023-10-27	Warnings	Exact identifier application number: M017
OsmoFlex	MENTHOL	Sarati International, Inc.	479147c0-4cf4-4d7a-8b8e-1a0de49ed73e	2023-10-27	Warnings	Exact identifier application number: M017
Thera plus Anti-itch with aloe Hydrocortisone	HYDROCORTISONE	Fourstar Group USA, Inc.	c69d0670-a65b-1680-e053-2995a90a2ee5	2023-10-26	Warnings	Exact identifier application number: M017
Family Wellness	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	FRONT PHARMACEUTICAL PLC	fde2069b-344e-46da-bb95-c5113e0f35d6	2023-10-26	Warnings	Exact identifier application number: M017
MAXIMUM STRENGTH HEMORRHOIDAL RELIEF	LIDOCAINE	CVS PHARMACY, INC	b61424bf-3b23-420b-a7bc-256ddb96aa22	2023-10-25	Warnings	Exact identifier application number: M017
Assured	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutic Al Co., Ltd.	bc97f364-9443-47b8-9c2d-b5dcc00cc9b7	2023-10-25	Warnings	Exact identifier application number: M017
Stopain Clinical	MENTHOL, UNSPECIFIED FORM	Troy Manufacturing, Inc.	b41091b4-0dc0-4a88-8ff6-11979b3d307a	2023-10-25	Warnings	Exact identifier application number: M017
Thera Plus	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	bcc99e5a-2403-46da-9c9d-8411fa4104e0	2023-10-25	Warnings	Exact identifier application number: M017
Assured	LIDOCAINE HYDROCHLORIDE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c	2023-10-25	Warnings	Exact identifier application number: M017
Red hot	CAPSAICIN	The Hygenic Company, LLC	d100092c-e10b-2063-e053-2995a90aedb2	2023-10-25	Warnings	Exact identifier application number: M017
Stopain Clinical	MENTHOL	Troy Manufacturing, Inc.	c8d4ae28-efc4-6a00-e053-2a95a90a40bf	2023-10-25	Warnings	Exact identifier application number: M017
Cryo10 Topical Analgesic	MENTHOL	Element 26 LLC	ff1d2140-9302-918c-e053-6394a90acb9a	2023-10-25	Warnings	Exact identifier application number: M017
Stopain Clinical	MENTHOL	Troy Manufacturing, Inc.	3336cc35-e773-4705-84b5-61040604beef	2023-10-25	Warnings	Exact identifier application number: M017
CARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin Protectant	BENZOCAINE, WHITE PETROLATUM	Carma Laboratories, Inc.	bbf0abcd-b7d6-b5e4-e053-2995a90a5240	2023-10-25	Warnings	Exact identifier application number: M017
Carmex Classic Lip Balm Medicated	CAMPHOR (SYNTHETIC), WHITE PETROLATUM	Carma Laboratories, Inc.	bbee66b9-39ff-4e7e-e053-2995a90a43be	2023-10-25	Warnings	Exact identifier application number: M017
XtraCare Ice Cold Topical Analgesic Gel	MENTHOL	Rejoice International	d38f3099-d940-44d8-aa7f-404157c5e0e3	2023-10-24	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