Bentasil

Product NDC: 63104-003
11-digit product format: 631040003
Labeler code: 63104
Product ID: 63104-003_5069cb14-68e1-4acc-8015-b3f12ad448ef
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol Eucalyptus
Dosage form: LOZENGE
Route: ORAL
Labeler: CLOETTA ITALIA S.r.l.
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-04-01
Marketing end: 0000-00-00
Substance: MENTHOL; EUCALYPTUS OIL
Active strength: 6 mg/1; mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
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	63104-003		I	Inactivated by FDA		2026-10-15
excluded package	package	63104-003	63104-003-20	I	Inactivated by FDA		2026-10-15

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 · 44 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	63104-003-20	`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	63104-003-20	`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	63104-003-20	`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	63104-003-20	`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	63104-003-20	`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	63104-003-20	`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	63104-003-20	`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	63104-003-20	`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	63104-003-20	`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	63104-003-20	`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	63104-003-20	`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	63104-003-20	`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	63104-003-20	`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	63104-003-20	`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	63104-003-20	`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	63104-003-20	`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	63104-003-20	`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	63104-003-20	`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	63104-003-20	`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	63104-003-20	`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	63104-003-20	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63104-003-20	`110d247fa046…`	`a55b01930146…`

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63104-003-20	2019-11-27	C162847	48780-1	9855e2a2-3417-60a7-e053-dbdaa90a05bd	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63104-003-20	BentasilSUGAR FREE EUCALYPTUS SOFT Texture	20 in 1 BAG	LOZENGE	20		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
EUCALYPTUS OIL	ACTIVE INGREDIENT	2R04ONI662	BENTASIL SUGAR FREE EUCALYPTUS SOFT TEXTURE (MENTHOL EUCALYPTUS) LOZENGE [CLOETTA ITALIA S.R.L.]	1
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	BENTASIL SUGAR FREE EUCALYPTUS SOFT TEXTURE (MENTHOL EUCALYPTUS) LOZENGE [CLOETTA ITALIA S.R.L.]	1
EUCALYPTUS OIL	ACTIVE MOIETY	2R04ONI662	BENTASIL SUGAR FREE EUCALYPTUS SOFT TEXTURE (MENTHOL EUCALYPTUS) LOZENGE [CLOETTA ITALIA S.R.L.]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	BENTASIL SUGAR FREE EUCALYPTUS SOFT TEXTURE (MENTHOL EUCALYPTUS) LOZENGE [CLOETTA ITALIA S.R.L.]	1
ACACIA	INACTIVE INGREDIENT	5C5403N26O	BENTASIL SUGAR FREE EUCALYPTUS SOFT TEXTURE (MENTHOL EUCALYPTUS) LOZENGE [CLOETTA ITALIA S.R.L.]	1
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	BENTASIL SUGAR FREE EUCALYPTUS SOFT TEXTURE (MENTHOL EUCALYPTUS) LOZENGE [CLOETTA ITALIA S.R.L.]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	BENTASIL SUGAR FREE EUCALYPTUS SOFT TEXTURE (MENTHOL EUCALYPTUS) LOZENGE [CLOETTA ITALIA S.R.L.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	BENTASIL SUGAR FREE EUCALYPTUS SOFT TEXTURE (MENTHOL EUCALYPTUS) LOZENGE [CLOETTA ITALIA S.R.L.]	1
COCONUT OIL	INACTIVE INGREDIENT	Q9L0O73W7L	BENTASIL SUGAR FREE EUCALYPTUS SOFT TEXTURE (MENTHOL EUCALYPTUS) LOZENGE [CLOETTA ITALIA S.R.L.]	1
MALTITOL	INACTIVE INGREDIENT	D65DG142WK	BENTASIL SUGAR FREE EUCALYPTUS SOFT TEXTURE (MENTHOL EUCALYPTUS) LOZENGE [CLOETTA ITALIA S.R.L.]	1
PALM KERNEL OIL	INACTIVE INGREDIENT	B0S90M0233	BENTASIL SUGAR FREE EUCALYPTUS SOFT TEXTURE (MENTHOL EUCALYPTUS) LOZENGE [CLOETTA ITALIA S.R.L.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	BENTASIL SUGAR FREE EUCALYPTUS SOFT TEXTURE (MENTHOL EUCALYPTUS) LOZENGE [CLOETTA ITALIA S.R.L.]	1
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	BENTASIL SUGAR FREE EUCALYPTUS SOFT TEXTURE (MENTHOL EUCALYPTUS) LOZENGE [CLOETTA ITALIA S.R.L.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63104-003	BENTASIL SUGAR FREE EUCALYPTUS SOFT TEXTURE (MENTHOL EUCALYPTUS) LOZENGE [CLOETTA ITALIA S.R.L.]	1	Legacy NDC, 1 package rows	20140510_008cf979-a632-419e-b4ae-2aa1f9831e7e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2R04ONI662	EUCALYPTUS OIL	8000-48-4	EUCALYPTUS OIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1537079	Bentasil Eucalyptus 5.8 MG / 5.7 MG Oral Lozenge	PSN	008cf979-a632-419e-b4ae-2aa1f9831e7e	1
1537073	eucalyptus oil 5.7 MG / menthol 5.8 MG Oral Lozenge	PSN	008cf979-a632-419e-b4ae-2aa1f9831e7e	1
1537079	Eucalyptus oil 5.7 MG / menthol 5.8 MG Oral Lozenge [Bentasil Eucalyptus]	SBD	008cf979-a632-419e-b4ae-2aa1f9831e7e	1
1537073	Eucalyptus oil 5.7 MG / menthol 5.8 MG Oral Lozenge	SCD	008cf979-a632-419e-b4ae-2aa1f9831e7e	1
1537079	Bentasil Eucalyptus (menthol 5.8 MG / eucalyptus oil 5.7 MG) Oral Lozenge	SY	008cf979-a632-419e-b4ae-2aa1f9831e7e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
63104-003-20	63104000320	20 in 1 BAG	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	CLOETTA ITALIA S.r.l. \| CLOETTA ITALY SAN PIETRO IN CASALE PLANT	2014-04-17	HUMAN OTC DRUG LABEL	1