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: METHYL SALICYLATE; THYMOL; EUCALYPTOL; MENTHOL
Active strength: .6; .64; .92; .42 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 36 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	872365ca-0c6b-550a-e053-2a91aa0ab25a	2024-06-14	Warnings	Exact identifier application number: M022
Amosan Oral Wound Cleanser Spearmint	SODIUM PERBORATE MONOHYDRATE	Vintage Brands Limited	7ac6c649-758f-4128-9920-466c0967b86a	2024-05-21	Warnings	Exact identifier application number: M022
Sensodyne	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	9e8e7b9f-3ccd-4935-b886-93f3a5045b67	2024-05-15	Warnings	Exact identifier application number: M022
Sensodyne Extra Whitening	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	1ed4a62b-f1d3-4740-8150-b94e02398740	2024-05-15	Warnings	Exact identifier application number: M022
Attitude Adult Fluoride-free - Sensitive - Spearmint	POTASSIUM NITRATE	9055-7588 Qubec Inc. DBA Attitude	46d5c908-f0e3-444c-9d96-461feef39137	2024-05-14	Warnings	Exact identifier application number: M022
sensodyne	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	16225f06-1d40-416a-aaec-7890e398fe4b	2024-05-13	Warnings	Exact identifier application number: M022
Sore Throat Cherry	PHENOL	QUALITY CHOICE (Chain Drug Marketing Association)	9162ae27-ddbb-4336-9655-487995919de4	2024-05-01	Warnings	Exact identifier application number: M022
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE AND POTASSIUM NITRATE	9055-7588 Quebec Inc. DBA Attitude	42b79ec5-f37f-4dc9-9631-c8b1c153fe88	2024-04-26	Warnings	Exact identifier application number: M022
Quality Choice Oral Pain Relief	BENZOCAINE 20%, BENZALKONIUM CHLORIDE 1%	Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)	162702b4-4bf7-8868-e063-6294a90a5921	2024-04-15	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	9991de96-99a1-42f0-9ddd-e530ca9ceab1	2024-04-11	Warnings	Exact identifier application number: M022
Aquafresh Extreme Clean Pure Breath Action	SODIUM FLUORIDE	Haleon US Holdings LLC	462eb309-deca-4464-b13a-7ae314e53ede	2024-04-08	Warnings	Exact identifier application number: M022
Sore Throat Cherry	PHENOL	Family Dollar (FAMILY WELLNESS)	7806fac7-736e-44b0-baa2-42feb7237417	2024-03-27	Warnings	Exact identifier application number: M022
Sucrets	DYCLONINE HCL, MENTHOL, AND PECTIN	Insight Pharmaceuticals LLC	2a2839ea-11d3-4390-930d-0da912a9c6f5	2024-03-20	Warnings	Exact identifier application number: M022
Sucrets Sore Throat Wild Cherry	DYCLONINE HYDROCHLORIDE	Insight Pharmaceuticals LLC	da4967c7-ee18-42e7-8c97-8919f3bb1b7d	2024-03-20	Warnings	Exact identifier application number: M022
NATEAN Clean plus Sensitivity Relief	POTASSIUM NITRATE, SODIUM FLUORIDE	Haleon US Holdings LLC	cea6f992-8a44-4eb8-baea-97b7b181b227	2024-03-19	Warnings	Exact identifier application number: M022
NATEAN Clean and Whiten	SODIUM FLUORIDE	Haleon US Holdings LLC	71b95962-2693-49f5-94d2-f2a035b5e0c8	2024-03-19	Warnings	Exact identifier application number: M022
SENSODYNE Sensitivity and Gum Mint	STANNOUS FLUORIDE	Haleon US Holdings LLC	ed093acd-255c-40ff-a010-d276f5844453	2024-03-07	Warnings	Exact identifier application number: M022
SENSODYNE Sensitivity Gum and Enamel Mint	STANNOUS FLUORIDE	Haleon US Holdings LLC	d4e9e5cf-d058-4c3f-ab5e-0b5a20a012e2	2024-03-07	Warnings	Exact identifier application number: M022
Sensodyne True white	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	671f8f45-389c-4375-be43-f5500ee21a0e	2024-03-07	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Strong and Bright Enamel Mint	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	be1ae382-0e01-4db8-90d7-fdadec2ff861	2024-03-06	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE
3J50XA376E	THYMOL	89-83-8	THYMOL
RV6J6604TK	EUCALYPTOL	470-82-6	EUCALYPTOL

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