Antiseptic

Product NDC: 55319-090
11-digit product format: 553190090
Labeler code: 55319
Product ID: 55319-090_d32a10b2-84f7-45f7-9cf5-0259066bb0ab
Type: HUMAN OTC DRUG
Nonproprietary name: Eucalyptol, Menthol, Methyl Salicylate, Thymol
Dosage form: LIQUID
Route: ORAL
Labeler: Family Dollar (FAMILY WELLNESS)
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-04-01
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55319-090		D	Discontinued by firm	2026-10-20
excluded package	package	55319-090	55319-090-01	D	Discontinued by firm	2026-10-20
excluded package	package	55319-090	55319-090-15	D	Discontinued by firm	2026-10-20
excluded package	package	55319-090	55319-090-25	D	Discontinued by firm	2026-10-20

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55319-090-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55319-090-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55319-090-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55319-090-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55319-090-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55319-090-15	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
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
269b9e7f-c5c8-4023-a3ea-e39040ade271	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
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55319-090-01	Antiseptic	1000 mL in 1 BOTTLE, PLASTIC	LIQUID	1000	8
55319-090-15	Antiseptic	1500 mL in 1 BOTTLE, PLASTIC	LIQUID	1500	8
55319-090-25	Antiseptic	250 mL in 1 BOTTLE, PLASTIC	LIQUID	250	8

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 37 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SENSODYNE Rapid Relief	STANNOUS FLUORIDE	Haleon US Holdings LLC	f9589e7c-c5ca-4465-8d37-47ad6c69249f	2024-03-06	Warnings	Exact identifier application number: M022
SENSODYNE Repair and Protect Extra Fresh	STANNOUS FLUORIDE	Haleon US Holdings LLC	34260c69-d829-46c0-b12a-5136ee073ba1	2024-03-06	Warnings	Exact identifier application number: M022
AQUAFRESH SENSITIVE MAXIMUM STRENGTH	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	76adbccb-0812-4407-a6fc-a57e6f144fbb	2024-03-05	Warnings	Exact identifier application number: M022
SENSODYNE Advanced Whitening	POTASSIUM NITRATE	Haleon US Holdings LLC	a06e2549-3c4e-4818-b53e-1dea6828219f	2024-03-04	Warnings	Exact identifier application number: M022
Sensodyne Extra Whitening Cool Mint	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	c977f2c4-e0f3-44d2-aa7a-845f0583af3e	2024-03-04	Warnings	Exact identifier application number: M022
Sensodyne Natural white	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	911ac7e4-2b92-43d5-af0b-b5f741b088fb	2024-03-04	Warnings	Exact identifier application number: M022
Sensodyne Nourish Healthy White	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	aca38560-2fd7-47be-9e93-2abc3214e856	2024-03-04	Warnings	Exact identifier application number: M022
Sensodyne Nourish Gently Soothing	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	5403ab67-532c-4bdf-9b06-07b1866f37f1	2024-03-04	Warnings	Exact identifier application number: M022
SENSODYNE PRONAMEL Active Shield Fresh Mint	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	e8684615-f544-4871-b935-0a0f93639d7d	2024-03-04	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Gentle Whitening Fresh Mint	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	3dfa6827-3aae-4f19-93f6-2ded2faf2ddd	2024-03-04	Warnings	Exact identifier application number: M022
Made by Dentists Sensitive and Whitening Fresh Mint	POTASSIUM NITRATE, SODIUM FLUORIDE	MADE BY DENTISTS INC	0d379c26-69ff-4666-9ad5-7618f0bd139f	2024-02-27	Warnings	Exact identifier application number: M022
Polident ProPartial	STANNOUS FLUORIDE	Haleon US Holdings LLC	557eeb32-64f4-41e8-ada4-91bd39ae2920	2024-02-07	Warnings	Exact identifier application number: M022
SENSODYNE PRONAMEL Daily Protection	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	edffce4d-108b-4ffd-9adf-e12cb42ffddd	2024-01-24	Warnings	Exact identifier application number: M022
Peppermint Twist	FLUORIDE	Caldwell Health LLC	4b28cdd1-0dba-42f5-a9e8-06d9e75b2396	2024-01-17	Warnings	Exact identifier application number: M022
The Natural Dentist Groovy Grape	FLUORIDE	Caldwell Consumer Health LLC	087abbed-1f58-4b45-a76b-a950fa81c18c	2024-01-16	Warnings	Exact identifier application number: M022
Benzoin Tincture	BENZOIN RESIN	Pharma Nobis, LLC	e42fccc2-1b4f-e7f3-e053-2a95a90aef39	2023-12-26	Warnings	Exact identifier application number: M022
Sunmark Benzoin Compound Tincture	BENZOIN RESIN	Strategic Sourcing Services LLC	0c96d810-83dc-47d3-9a75-63a79feaad0a	2023-12-19	Warnings	Exact identifier application number: M022
Benzoin Tincture	BENZOIN RESIN	Humco Holding Group, Inc.	b33b5896-673b-498c-8a58-76ece8552f7a	2023-12-15	Warnings	Exact identifier application number: M022
Povidone Iodine	POVIDONE IODINE ORAL RINSE 0.5%	Humco Holding Group, Inc.	b83dbdd1-ff63-caf8-e053-2a95a90a5764	2023-12-15	Warnings	Exact identifier application number: M022
Moon Whitening Gel Anticavity	SODIUM FLUORIDE	Moon Oral Care, LLC	0c556a29-a697-3a66-e063-6394a90abfee	2023-12-12	Warnings	Exact identifier application number: M022

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	269b9e7f-c5c8-4023-a3ea-e39040ade271	8
1043619	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash	SCD	269b9e7f-c5c8-4023-a3ea-e39040ade271	8
1043619	eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash	SY	269b9e7f-c5c8-4023-a3ea-e39040ade271	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55319-090-01	55319009001	1000 mL in 1 BOTTLE, PLASTIC (55319-090-01)	1000 ml	2025-06-01	No	No	Current
55319-090-15	55319009015	1500 mL in 1 BOTTLE, PLASTIC (55319-090-15)	1500 ml	2025-06-01	No	No	Current
55319-090-25	55319009025	250 mL in 1 BOTTLE, PLASTIC (55319-090-25)	250 ml	2025-06-01	No	No	Current