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 138 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cool n Heat	COOL N HEAT	NeilMed Pharmaceuticals, Inc.	a24cde17-280b-8358-e053-2a95a90af67d	2024-01-11	Warnings	Exact identifier application number: M017
NeilMed Anti-Itch	ANTI-ITCH SPRAY	NeilMed Pharmaceuticals Inc.	b3d34d9e-85d9-df4e-e053-2a95a90ac8d9	2024-01-11	Warnings	Exact identifier application number: M017
NeilMed Hot and Cold Pain Relief	PAIN RELIEF SPRAY	NeilMed Pharmaceuticals Inc.	b3d02111-7499-c2d4-e053-2a95a90ae1de	2024-01-11	Warnings	Exact identifier application number: M017
Cooling Itch Relief	COOLING ITCH RELIEF	NeilMed Pharmaceuticals, Inc	a24bdea0-18e8-8a5e-e053-2995a90acea2	2024-01-11	Warnings	Exact identifier application number: M017
Lightning X Burn	LIDOCAINE	Nantong Health & Beyond Hygienic Products Inc.	0e69a971-0c6e-6ebe-e063-6394a90a0b33	2024-01-08	Warnings	Exact identifier application number: M017
Theraworx Pain Relief Roll-On with Lidocaine for Diabetics	LIDOCAINE HYDROCHLORIDE	AVADIM HOLDINGS, INC.	e07f5bf7-5a9a-468c-8c3f-2c6f0b17af29	2024-01-08	Warnings	Exact identifier application number: M017
2nd CHANCE MOBILITY Pain Relief	HISTAMINE DIHYDROCHLORIDE	ALPHA NUTRITION, LLC	575097ac-9fc9-4391-99d1-dff9b34817e3	2024-01-08	Warnings	Exact identifier application number: M017
Tiger Balm Arthritis Rub	CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM	Haw Par Healthcare Ltd.	80932288-4797-40d3-aa8a-6af686fb67ad	2024-01-08	Warnings	Exact identifier application number: M017
OPRAVA	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Biological M.D. Solutions LLC	05552560-e283-5eba-e063-6294a90a65f7	2024-01-06	Warnings	Exact identifier application number: M017
MED O-3 BIO-	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Biological M.D. Solutions LLC	02707552-03d9-3ad2-e063-6294a90a3472	2024-01-06	Warnings	Exact identifier application number: M017
Sumifun Knee Relieving Patch	KNEE RELIEVING PATCH	Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd	0e7e73ec-ab33-9235-e063-6394a90ad950	2024-01-06	Warnings	Exact identifier application number: M017
Lidocaine Numbing Cream	LIDOCAINE	YYBA Corp	de6dc194-c6ef-4cb5-be3f-e772ace9abaf	2024-01-03	Warnings	Exact identifier application number: M017
Equate Vagicaine	20% BENZOCAINE AND 3% RESORCINOL CREAM	Walmart Inc.	0cdc9323-f5c3-468c-a7ae-83dfd2d76626	2024-01-03	Warnings	Exact identifier application number: M017
OWELL NATURALS Deep Penetrating Pain Relief	MENTHOL	OWELL NATURALS BRAND, LLC	b36eb017-ed8d-476e-994b-22b275e00543	2024-01-02	Warnings	Exact identifier application number: M017
Dibucaine	DIBUCAINE 1%	Trifecta Pharmaceuticals USA LLC	e8a56651-a292-7609-e053-2a95a90a7c36	2024-01-02	Warnings	Exact identifier application number: M017
Anti-Itch Cream	DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%	Trifecta Pharmaceuticals USA, LLC.	44d17651-a31b-64ca-e054-00144ff8d46c	2024-01-02	Warnings	Exact identifier application number: M017
Muscle Rub Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Trifecta Pharmaceuticals USA, LLC.	e0a13344-5493-eb51-e053-2995a90a8183	2024-01-02	Warnings	Exact identifier application number: M017
Sumifun Knee Relieve Patch	KNEE RELIEVE PATCH	Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd	0e031aa5-edf4-8c9d-e063-6394a90afee3	2024-01-02	Warnings	Exact identifier application number: M017
OKeeffes Healthy Feet	ALLANTOIN, LIDOCAINE	The Gorilla Glue Company/O'Keeffe's Company	d73709db-3932-3c56-e053-2995a90a7d0a	2024-01-01	Warnings	Exact identifier application number: M017
PERSONAL CARE ICE COLD	MENTHOL	NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.	1994356c-e347-5b7d-e063-6394a90a476c	2024-01-01	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