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 131 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ling Nam Hung Far	METHYL SALICYLATE	Ling Nam Medicine Factory (H.K.) Ltd.	b6916b6e-b7eb-1eb7-e053-2995a90ae6fb	2024-07-18	Warnings	Exact identifier application number: M017
itch relief	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Bionpharma Inc.	178ed513-4f22-8f11-e063-6294a90a109b	2024-07-16	Warnings	Exact identifier application number: M017
POWERECT Benzocaine Male Delay Gel	BENZOCAINE	SKINS SEXUAL HEALTH LIMITED	2fafe1f2-a31e-4b2a-bc51-81e16b319c3a	2024-07-16	Warnings	Exact identifier application number: M017
SKINS DELAY Climax Control Benzocaine Gel	BENZOCAINE	SKINS SEXUAL HEALTH LIMITED	53730576-2609-4f28-8bfa-a1ceea698b83	2024-07-16	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF CRYO THERAPY Unscented formula Spray.	PAIN RELIEF CRYO THERAPY UNSCENTED FORMULA SPRAY	Shenzhen Sam Technology Co., Ltd.	1d1a0346-3b00-4803-e063-6294a90aec6d	2024-07-13	Warnings	Exact identifier application number: M017
Tidl Pain Relief Evening Therapy Spray.	PAIN RELIEF EVENING THERAPY SPRAY	Shenzhen Sam Technology Co., Ltd.	1d1a2f4a-7b25-e595-e063-6394a90a00d5	2024-07-13	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF HEAT THERAPY ROLL-ON	PAIN RELIEF HEAT THERAPY ROLL-ON	Shenzhen Sam Technology Co., Ltd.	1d0b7b8f-9e5d-00f7-e063-6394a90af87c	2024-07-12	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF CRYO THERAPY original formula Spray.	PAIN RELIEF CRYO THERAPY ORIGINAL FORMULA SPRAY	Shenzhen Sam Technology Co., Ltd.	1d0b94ec-f956-dff2-e063-6294a90aca4a	2024-07-12	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF CRYO THERAPY MAX Strength Spray.	PAIN RELIEF CRYO THERAPY MAX STRENGTH SPRAY	Shenzhen Sam Technology Co., Ltd.	1d0bf4f9-6b02-6cec-e063-6294a90a36c7	2024-07-12	Warnings	Exact identifier application number: M017
Burn Relief	LIDOCAINE HCI 2.0%	Trifecta Pharmaceuticals USA, LLC.	e5e524cd-bb22-715f-e053-2995a90ab5d3	2024-07-12	Warnings	Exact identifier application number: M017
Ralli Rapid Pain Relief	MENTHOL	Troy Manufacturing, Inc.	1d10e3ca-dc93-8e1a-e063-6394a90a47c0	2024-07-12	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF HEAT THERAPY Spray.	PAIN RELIEF HEAT THERAPY SPRAY	Shenzhen Sam Technology Co., Ltd.	1d199826-1b27-b6e7-e063-6394a90a69ad	2024-07-12	Warnings	Exact identifier application number: M017
Tidl Pain Relief Morning Therapy Spray.	PAIN RELIEF MORNING THERAPY SPRAY	Shenzhen Sam Technology Co., Ltd.	1d19d070-3818-73de-e063-6394a90a8958	2024-07-12	Warnings	Exact identifier application number: M017
Hydrocortisone with aloe	HYDROCORTISONE WITH ALOE ANTI ITCH	NeilMed Pharmaceuticals Inc.	032b9f58-5f64-04dd-e063-6294a90a6bb9	2024-07-10	Warnings	Exact identifier application number: M017
Octagon Pain Relief	MENTHOL, UNSPECIFIED FORM	NATURAL ESSENTIALS, INC.	9926f733-1506-4224-9d70-b1813cd81ec3	2024-07-08	Warnings	Exact identifier application number: M017
LidoReal Patch	LIDOCAINE AND MENTHOL	FORREAL PHARMACEUTICALS LLC	19f1c037-b4b8-47b0-b0f9-036691c1d307	2024-07-05	Warnings	Exact identifier application number: M017
Lip Medex Lip Balm	PETROLATUM, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOL	Blistex Inc.	988f97e8-a59f-4bc0-9d71-60607364a686	2024-07-01	Warnings	Exact identifier application number: M017
Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALM	MENTHOL	L'Oreal USA Products Inc	d580982f-dda6-4b03-bf84-342b9f2c6d93	2024-06-29	Warnings	Exact identifier application number: M017
Lip Medex Cherry	PETROLATUM, CAMPHOR (SYNTHETIC), AND MENTHOL, UNSPECIFIED FORM	Blistex Inc.	fa8b3fb1-08e5-4876-9c4a-6aa8c9f23af8	2024-06-28	Warnings	Exact identifier application number: M017
10% Methyl Salicylate Pain Relief Patch	10% METHYL SALICYLATE	Akron Coating & Adhesives	1be1f1ce-3238-a8ed-e063-6294a90a5aed	2024-06-27		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