Elyptol Antimicrobial Rub

Product NDC: 69343-221
11-digit product format: 693430221
Labeler code: 69343
Product ID: 69343-221_c47506d3-a699-4f9a-b9bd-6f26219d8fa0
Type: HUMAN OTC DRUG
Nonproprietary name: Ethanol
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Elyptol Inc.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-11-01
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 7 mL/10mL
NDC exclude flag: No
Listing certified through: 2024-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69343-221		I	Inactivated by FDA	2026-10-15
excluded package	package	69343-221	69343-221-02	I	Inactivated by FDA	2026-10-15
excluded package	package	69343-221	69343-221-03	I	Inactivated by FDA	2026-10-15
excluded package	package	69343-221	69343-221-08	I	Inactivated by FDA	2026-10-15
excluded package	package	69343-221	69343-221-16	I	Inactivated by FDA	2026-10-15
excluded package	package	69343-221	69343-221-34	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 2 · 66 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	69343-221-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69343-221-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69343-221-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69343-221-34	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69343-221-03	`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	69343-221-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69343-221-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69343-221-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69343-221-34	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69343-221-03	`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	69343-221-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69343-221-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69343-221-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69343-221-34	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69343-221-03	`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	69343-221-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69343-221-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69343-221-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69343-221-34	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69343-221-03	`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	69343-221-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69343-221-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69343-221-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69343-221-34	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69343-221-03	`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	69343-221-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69343-221-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69343-221-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69343-221-34	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69343-221-03	`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	69343-221-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69343-221-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69343-221-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69343-221-34	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69343-221-03	`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	69343-221-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69343-221-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69343-221-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69343-221-34	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69343-221-03	`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	69343-221-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69343-221-16	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69343-221-08	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69343-221-34	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69343-221-03	`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	69343-221-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69343-221-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69343-221-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69343-221-34	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69343-221-03	`ad56d346431e…`	`cc804d4bbf1e…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
69343-221-02	2024-07-30	Elyptol Antimicrobial Rub
69343-221-03	2024-07-30	Elyptol Antimicrobial Rub
69343-221-08	2024-07-30	Elyptol Antimicrobial Rub
69343-221-16	2024-07-30	Elyptol Antimicrobial Rub
69343-221-34	2024-07-30	Elyptol Antimicrobial Rub
69343-221-02	2024-01-30	Elyptol Antimicrobial Rub
69343-221-03	2024-01-30	Elyptol Antimicrobial Rub
69343-221-08	2024-01-30	Elyptol Antimicrobial Rub
69343-221-16	2024-01-30	Elyptol Antimicrobial Rub
69343-221-34	2024-01-30	Elyptol Antimicrobial Rub

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69343-221-02	Elyptol Antimicrobial Rub	59 mL in 1 BOTTLE	SOLUTION	59	6
69343-221-02	Elyptol Antimicrobial Rub	1 in 1 CARTON	SOLUTION	1	6
69343-221-03	Elyptol Antimicrobial Rub	89 mL in 1 BOTTLE	SOLUTION	89	6
69343-221-03	Elyptol Antimicrobial Rub	1 in 1 CARTON	SOLUTION	1	6
69343-221-08	Elyptol Antimicrobial Rub	1 in 1 CARTON	SOLUTION	1	6
69343-221-08	Elyptol Antimicrobial Rub	236 mL in 1 BOTTLE	SOLUTION	236	6
69343-221-16	Elyptol Antimicrobial Rub	473 mL in 1 BOTTLE	SOLUTION	473	6
69343-221-16	Elyptol Antimicrobial Rub	1 in 1 CARTON	SOLUTION	1	6
69343-221-34	Elyptol Antimicrobial Rub	1005 mL in 1 BOTTLE	SOLUTION	1005	6
69343-221-34	Elyptol Antimicrobial Rub	1 in 1 CARTON	SOLUTION	1	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	ELYPTOL ANTIMICROBIAL RUB (ETHANOL) SOLUTION [ELYPTOL INC.]	1
ALCOHOL	ACTIVE MOIETY	3K9958V90M	ELYPTOL ANTIMICROBIAL RUB (ETHANOL) SOLUTION [ELYPTOL INC.]	1
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	ELYPTOL ANTIMICROBIAL RUB (ETHANOL) SOLUTION [ELYPTOL INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ELYPTOL ANTIMICROBIAL RUB (ETHANOL) SOLUTION [ELYPTOL INC.]	1
PIROCTONE OLAMINE	INACTIVE INGREDIENT	A4V5C6R9FB	ELYPTOL ANTIMICROBIAL RUB (ETHANOL) SOLUTION [ELYPTOL INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ELYPTOL ANTIMICROBIAL RUB (ETHANOL) SOLUTION [ELYPTOL INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69343-221	ELYPTOL ANTIMICROBIAL RUB (ETHANOL) SOLUTION [ELYPTOL INC.]	6	Legacy NDC, 10 package rows	20230105_a6903410-ab88-4634-9937-4b2d00e07915.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
582753	ethanol 70 % Topical Solution	PSN	a6903410-ab88-4634-9937-4b2d00e07915	6
582753	ethanol 0.7 ML/ML Topical Solution	SCD	a6903410-ab88-4634-9937-4b2d00e07915	6
582753	ethanol 70 % Topical Solution	SY	a6903410-ab88-4634-9937-4b2d00e07915	6
582753	ethyl alcohol 70 % Topical Solution	SY	a6903410-ab88-4634-9937-4b2d00e07915	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69343-221-02	69343022102	1 BOTTLE in 1 CARTON (69343-221-02) > 59 mL in 1 BOTTLE	1 bottle	2014-11-01	0000-00-00	No	No	Current
69343-221-03	69343022103	1 BOTTLE in 1 CARTON (69343-221-03) > 89 mL in 1 BOTTLE	1 bottle	2014-11-01	0000-00-00	No	No	Current
69343-221-08	69343022108	1 BOTTLE in 1 CARTON (69343-221-08) > 236 mL in 1 BOTTLE	1 bottle	2014-11-01	0000-00-00	No	No	Current
69343-221-16	69343022116	1 BOTTLE in 1 CARTON (69343-221-16) > 473 mL in 1 BOTTLE	1 bottle	2014-11-01	0000-00-00	No	No	Current
69343-221-34	69343022134	1 BOTTLE in 1 CARTON (69343-221-34) > 1005 mL in 1 BOTTLE	1 bottle	2014-11-01	0000-00-00	No	No	Current