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	2026-08-17
excluded package	package	55319-090	55319-090-01	D	Discontinued by firm	2026-08-17
excluded package	package	55319-090	55319-090-15	D	Discontinued by firm	2026-08-17
excluded package	package	55319-090	55319-090-25	D	Discontinued by firm	2026-08-17

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…`

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 1 of 42 · 823 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Harris Teeter, LLC	7e5f175d-f0d6-4665-ac14-1873d6b99c80	2026-08-12	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	WALMART INC. (see also Equate)	584b38ce-d1ef-4ecc-a887-7c96e7f9669f	2026-08-12	Warnings	Exact identifier application number: M022
Gingicaine Gel Variety Pak	GINGICAINE GEL VARIETY PAK	Gingi-Pak a Division of the Belport	62ed4ff3-18f6-5c67-e053-2991aa0a7792	2026-08-11	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent ReadyInCase	HYDROGEN PEROXIDE	P & L Development, LLC	b0866db5-3b0d-4478-9b3b-1f077d2f5393	2026-08-06	Warnings	Exact identifier application number: M022
Ollie Fresh Mint	SODIUM FLUORIDE, POTASSIUM NITRATE	Brio Product Group LLC.	ebeec44f-3c22-43f2-9256-6ece6025c105	2026-08-06	Warnings	Exact identifier application number: M022
Tumeez Organic Apple	CALCIUM CARBONATE	BFY LLC	f561685a-5260-59c6-e053-2a95a90ae206	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	5868c5a1-273f-f023-e063-6394a90ac9d8	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	58690bb5-9604-26a4-e063-6394a90afdbe	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	586918cf-7b13-5999-e063-6294a90a88a9	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	586924a0-322d-5dc3-e063-6294a90a1556	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	58692e90-de74-52d3-e063-6394a90a9702	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	586937ae-46af-7066-e063-6294a90ae53e	2026-08-06	Warnings	Exact identifier application number: M022
Freshness Blueberry Toothpaste100g	FRESHNESS BLUEBERRY TOOTHPASTE 100G	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	586d1dba-87fc-b676-e063-6294a90a1470	2026-08-06	Warnings	Exact identifier application number: M022
Freshness Coffee Toothpaste100g	FRESHNESS COFFEE TOOTHPASTE 100G	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	586d79e9-2f0f-fa72-e063-6394a90a8dea	2026-08-06	Warnings	Exact identifier application number: M022
Freshness Flower Rose Toothpaste100g	FRESHNESS FLOWER ROSE TOOTHPASTE 100G	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	586d7f5e-55e0-4fd2-e063-6294a90a92b6	2026-08-06	Warnings	Exact identifier application number: M022
PRO-SYS	ORAL WOUND CLEANSER	Forward Science Technologies LLC	c357c8f8-6fd6-c2f8-e053-2995a90a4023	2026-07-30	Warnings	Exact identifier application number: M022
Lornamead Natural White	FLUORIDE	Lornamead Products	9d7d08d7-8ca4-4b05-8b74-3bfa372b1608	2026-07-29	Warnings	Exact identifier application number: M022
Made by Dentists Enamel 10 Fluoride Anticavity	POTASSIUM NITRATE, SODIUM FLUORIDE	Made By Dentists Inc	3c62eab1-0cb6-4bdf-bfd4-c5afe734d036	2026-07-24	Warnings	Exact identifier application number: M022
Saline	NASAL	BEST CHOICE (VALU MERCHANDISERS COMPANY)	71485e82-bf54-4b8b-8dd2-2a0761534520	2026-07-17	Warnings	Exact identifier application number: M022
Good Neighbor Sore Throat Cherry Flavor	PHENOL	AMERISOURCE BERGEN	aa8fb8ff-61c7-41ba-9a23-1052e2b6cd7f	2026-07-13	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