Waterless Anti-Bacterial Hand Cleanser

Product NDC: 49852-025
11-digit product format: 498520025
Labeler code: 49852
Product ID: 49852-025_34b5a5ce-990e-1525-e054-00144ff8d46c
Type: HUMAN OTC DRUG
Nonproprietary name: Ethyl Alcohol
Dosage form: LIQUID
Route: TOPICAL
Labeler: Tri-Coastal Design Company Inc.
Application: part333E
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2009-12-01
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 62 mL/100mL
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49852-025		I	Inactivated by FDA	2026-10-05
excluded package	package	49852-025	49852-025-08	I	Inactivated by FDA	2026-10-05
excluded package	package	49852-025	49852-025-30	I	Inactivated by FDA	2026-10-05
excluded package	package	49852-025	49852-025-45	I	Inactivated by FDA	2026-10-05
excluded package	package	49852-025	49852-025-60	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 2 · 105 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	49852-025-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49852-025-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49852-025-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49852-025-60	`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	49852-025-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49852-025-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49852-025-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49852-025-60	`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	49852-025-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49852-025-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49852-025-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49852-025-60	`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	49852-025-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49852-025-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49852-025-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49852-025-60	`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	49852-025-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49852-025-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49852-025-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49852-025-60	`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	49852-025-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49852-025-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49852-025-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49852-025-60	`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	49852-025-45	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49852-025-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49852-025-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49852-025-60	`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	49852-025-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49852-025-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49852-025-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49852-025-60	`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	49852-025-45	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49852-025-08	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49852-025-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49852-025-60	`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	49852-025-45	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49852-025-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49852-025-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49852-025-60	`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	49852-025-45	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49852-025-08	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49852-025-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49852-025-60	`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	49852-025-45	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49852-025-08	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49852-025-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49852-025-60	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
49852-025-08	Drug Facts
49852-025-30	Drug Facts
49852-025-45	Drug Facts
49852-025-60	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49852-025-08	Waterless Anti-Bacterial Hand Cleanser	250 mL in 1 BOTTLE, PLASTIC	LIQUID	250	2
49852-025-30	Waterless Anti-Bacterial Hand Cleanser	30 mL in 1 BOTTLE, PLASTIC	LIQUID	30	2
49852-025-45	Waterless Anti-Bacterial Hand Cleanser	45 mL in 1 BOTTLE, PLASTIC	LIQUID	45	2
49852-025-60	Waterless Anti-Bacterial Hand Cleanser	60 mL in 1 BOTTLE, PLASTIC	LIQUID	60	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	WATERLESS ANTI-BACTERIAL HAND CLEANSER (ETHYL ALCOHOL) LIQUID [TRI-COASTAL DESIGN COMPANY INC. ]	1
ALCOHOL	ACTIVE MOIETY	3K9958V90M	WATERLESS ANTI-BACTERIAL HAND CLEANSER (ETHYL ALCOHOL) LIQUID [TRI-COASTAL DESIGN COMPANY INC. ]	1
ALPHA-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	WATERLESS ANTI-BACTERIAL HAND CLEANSER (ETHYL ALCOHOL) LIQUID [TRI-COASTAL DESIGN COMPANY INC. ]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	WATERLESS ANTI-BACTERIAL HAND CLEANSER (ETHYL ALCOHOL) LIQUID [TRI-COASTAL DESIGN COMPANY INC. ]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	WATERLESS ANTI-BACTERIAL HAND CLEANSER (ETHYL ALCOHOL) LIQUID [TRI-COASTAL DESIGN COMPANY INC. ]	1
POLYOXYL 40 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	7YC686GQ8F	WATERLESS ANTI-BACTERIAL HAND CLEANSER (ETHYL ALCOHOL) LIQUID [TRI-COASTAL DESIGN COMPANY INC. ]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	WATERLESS ANTI-BACTERIAL HAND CLEANSER (ETHYL ALCOHOL) LIQUID [TRI-COASTAL DESIGN COMPANY INC. ]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	WATERLESS ANTI-BACTERIAL HAND CLEANSER (ETHYL ALCOHOL) LIQUID [TRI-COASTAL DESIGN COMPANY INC. ]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	WATERLESS ANTI-BACTERIAL HAND CLEANSER (ETHYL ALCOHOL) LIQUID [TRI-COASTAL DESIGN COMPANY INC. ]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49852-025	WATERLESS ANTI-BACTERIAL HAND CLEANSER (ETHYL ALCOHOL) LIQUID [TRI-COASTAL DESIGN COMPANY INC.]	2	Legacy NDC, 4 package rows	20160608_0dbef37a-bb46-447e-9c3b-0cedebf1f997.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
581660	ethanol 62 % Topical Gel	PSN	0dbef37a-bb46-447e-9c3b-0cedebf1f997	2
581660	ethanol 0.62 ML/ML Topical Gel	SCD	0dbef37a-bb46-447e-9c3b-0cedebf1f997	2
581660	ethanol 62 % Topical Gel	SY	0dbef37a-bb46-447e-9c3b-0cedebf1f997	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
49852-025-08	49852002508	250 mL in 1 BOTTLE, PLASTIC	250 ml	Historical
49852-025-30	49852002530	30 mL in 1 BOTTLE, PLASTIC	30 ml	Historical
49852-025-45	49852002545	45 mL in 1 BOTTLE, PLASTIC	45 ml	Historical
49852-025-60	49852002560	60 mL in 1 BOTTLE, PLASTIC	60 ml	Historical