Royal Mouthwash Fresh and Clean Original Mint

Product NDC: 50438-304
11-digit product format: 504380304
Labeler code: 50438
Product ID: 50438-304_1dd6b65e-11df-4ec2-93af-70888a53b1b1
Type: HUMAN OTC DRUG
Nonproprietary name: EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL
Dosage form: LIQUID
Route: ORAL
Labeler: Filo America
Application: part356
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-09-17
Marketing end: 0000-00-00
Substance: EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL
Active strength: 1 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50438-304		I	Inactivated by FDA		2026-10-05
excluded package	package	50438-304	50438-304-01	I	Inactivated by FDA		2026-10-05

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 · 42 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	50438-304-01	`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	50438-304-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50438-304-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50438-304-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50438-304-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50438-304-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50438-304-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50438-304-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50438-304-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50438-304-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50438-304-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50438-304-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50438-304-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50438-304-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50438-304-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50438-304-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50438-304-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50438-304-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50438-304-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	50438-304-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	50438-304-01	`9bebd1f3094a…`	`5416666fcb17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50438-304-01	2020-01-31	C162847	48780-1	9d75b9d1-0756-f424-e053-dadaa90a57ce	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50438-304-01	Royal Mouthwash Fresh and Clean Original Mint	1000 mL in 1 BOTTLE, PLASTIC	LIQUID	1000		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
EUCALYPTOL	ACTIVE INGREDIENT	RV6J6604TK	ROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]	1
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	ROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]	1
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	ROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]	1
THYMOL	ACTIVE INGREDIENT	3J50XA376E	ROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]	1
EUCALYPTOL	ACTIVE MOIETY	RV6J6604TK	ROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	ROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]	1
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	ROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]	1
THYMOL	ACTIVE MOIETY	3J50XA376E	ROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	ROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	ROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	ROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50438-304	ROYAL MOUTHWASH FRESH AND CLEAN ORIGINAL MINT (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [FILO AMERICA]	1	Legacy NDC, 1 package rows	20130917_3830dc3a-98f7-4b56-b3ae-281bb24e2e1f.zip

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	3830dc3a-98f7-4b56-b3ae-281bb24e2e1f	1
1043619	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash	SCD	3830dc3a-98f7-4b56-b3ae-281bb24e2e1f	1
1043619	eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash	SY	3830dc3a-98f7-4b56-b3ae-281bb24e2e1f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
50438-304-01	50438030401	1000 mL in 1 BOTTLE, PLASTIC	1000 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DRUG FACTS	Filo America \| Ningbo Pulisi Daily Chemical Products Co., Ltd.	2013-09-17	HUMAN OTC DRUG LABEL	1