Mouthwash

Product NDC: 71927-006
11-digit product format: 719270006
Labeler code: 71927
Product ID: 71927-006_323a2253-01b0-de24-e063-6394a90ae0d7
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol, Methyl salicylate, Thymol
Dosage form: LIQUID
Route: ORAL
Labeler: Orazen Inc
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-04-22
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: 2026-12-31
Current FDA listing: Yes

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71927-006-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71927-006-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71927-006-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71927-006-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71927-006-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71927-006-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71927-006-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: Mouthwash
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYL SALICYLATE	.6 mg/mL
THYMOL	.64 mg/mL
EUCALYPTOL	.92 mg/mL
MENTHOL	.42 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
LAV5U5022Y	Internal UNII lookup
3J50XA376E	Internal UNII lookup
RV6J6604TK	Internal UNII lookup
L7T10EIP3A	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
873c43df-1d46-359b-e053-2a91aa0a4319	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71927-006-01	2025-04-07	C162847	48780-1	2cef2736-7d13-d83d-e063-dadaa90ab31f	71927-006
71927-006-01	2025-01-30	C162847	48780-1	2cef2736-7d13-d83d-e063-dadaa90ab31f	71927-006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71927-006-01	Mouthwash	251 mL in 1 BOTTLE	LIQUID	251		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71927-006	MOUTHWASH (MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [ORAZEN INC]	2	Current NDC, Legacy NDC, 1 package rows	20250409_873c43df-1d46-359b-e053-2a91aa0a4319.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 1 of 41 · 819 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CrystLCare Regeneration Plus	POTASSIUM NITRATE, SODIUM FLUORIDE	GreenMark Biomedical Inc.	4f86d0a0-d73e-5605-e063-6394a90adb38	2026-09-14	Warnings	Exact identifier application number: M022
Opalescence Whitening Sensitivity Relief	POTASSIUM NITRATE AND SODIUM FLUORIDE	Ultradent Products, Inc.	44e94663-895b-67da-e063-6394a90a5fe6	2026-09-09	Warnings	Exact identifier application number: M022
Opalescence Sensitivity Relief Whitening	POTASSIUM NITRATE AND SODIUM FLUORIDE	Ultradent Products, Inc.	b5176a84-76a3-4ad0-a2e2-4997a12da9a5	2026-09-09	Warnings	Exact identifier application number: M022
Opal by Opalescence Sensitivity	POTASSIUM NITRATE AND SODIUM FLUORIDE	Ultradent Products, Inc.	5ffc0d14-0290-47bb-90e5-90a25a5acc28	2026-09-09	Warnings	Exact identifier application number: M022
Saline	NASAL	Raritan Pharmaceuiticals Inc	4b178e4e-a10f-4b75-8140-1f7548e203ad	2026-09-09	Warnings	Exact identifier application number: M022
SORE THROAT	PHENOL	Raritan Pharmaceuticals Inc	43ce374a-824c-4034-bf04-c351b4d8015b	2026-09-08	Warnings	Exact identifier application number: M022
Colgate Optic White Stain Fighter Sens Relief	SODIUM FLUORIDE	Colgate-Palmolive Company	6ec2fff7-df44-4302-be2d-97946c6cd66a	2026-09-08	Warnings	Exact identifier application number: M022
DRx Choice Sore Throat Menthol Flavor	PHENOL	RARITAN PHARMACEUTICALS INC	e3269b12-5c05-45a6-81f2-65d9f016c3aa	2026-09-08	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	AmerisourceBergen (Good Neighbor Pharmacy) 46122	0733015b-e81a-4a62-82ad-dacaf3f163cb	2026-09-02	Warnings	Exact identifier application number: M022
KROGER Saline	NASAL	KROGER COMPANY	c84b242b-f46e-4ea8-a3c1-109a47644646	2026-09-02	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	WALMART INC. (see also Equate)	ceb125d9-8c1b-498c-b0f0-f18756ede442	2026-09-01	Warnings	Exact identifier application number: M022
Orajel 4X Medicated Toothache and Gum Cream	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1c82b4-02b3-d456-e063-6294a90a16bb	2026-08-31	Warnings	Exact identifier application number: M022
Orajel 4X Medicated Toothache and Gum PM Cream	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1cdaf4-3388-280c-e063-6294a90ac70f	2026-08-31	Warnings	Exact identifier application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORT	HEXYLRESORCINOL	Reckitt Benckiser LLC	91cd2964-5d83-4e40-bc18-e3e5462f454a	2026-08-31	Warnings	Exact identifier application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF	HEXYLRESORCINOL	Reckitt Benckiser LLC	4c150222-06ea-4fcf-967f-84e19846bd66	2026-08-31	Warnings	Exact identifier application number: M022
Orajel 4X Medicated Toothache and Gum	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1b4133-0eac-2f8f-e063-6394a90af8f6	2026-08-28	Warnings	Exact identifier application number: M022
LUDENS SUGAR FREE WILD CHERRY THROAT	PECTIN	Prestige Brands Holdings, Inc.	274fc80c-e5b2-41c7-a119-287d6e8a2258	2026-08-28	Warnings	Exact identifier application number: M022
Medline Peroxi Fresh Mouthwash	HYDROGEN PEROXIDE	Medline Industries, LP	ec7a9240-6c66-4471-b8b6-776e08a14fbc	2026-08-27	Warnings	Exact identifier application number: M022
Saline	SALINE NASAL SPRAY	Dynarex Corporation	3247ae7d-554f-baab-e063-6294a90aa3ec	2026-08-25	Warnings	Exact identifier application number: M022
Tumeez Organic Apple	CALCIUM CARBONATE	BFY LLC	f561685a-5260-59c6-e053-2a95a90ae206	2026-08-25	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	873c43df-1d46-359b-e053-2a91aa0a4319	2
1043619	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash	SCD	873c43df-1d46-359b-e053-2a91aa0a4319	2
1043619	eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash	SY	873c43df-1d46-359b-e053-2a91aa0a4319	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71927-006-01	71927000601	251 mL in 1 BOTTLE (71927-006-01)	251 ml	2019-04-22	0000-00-00	No	No	Current