TopCare Amber Antibacterial Hand

Product NDC: 20890-0050
11-digit product format: 208900050
Labeler code: 20890
Product ID: 20890-0050_d428c448-6e4a-1e4f-e053-2a95a90a1f2a
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium Chloride
Dosage form: SOAP
Route: TOPICAL
Labeler: Abaco Partners LLC DBA Surefil
Application: part333E
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-12-15
Marketing end: 0000-00-00
Substance: BENZALKONIUM CHLORIDE
Active strength: 13 mg/10mL
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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 · 49 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	20890-0050-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	20890-0050-2	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	20890-0050-1	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	20890-0050-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	20890-0050-2	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	20890-0050-1	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	20890-0050-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	20890-0050-2	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	20890-0050-1	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	20890-0050-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	20890-0050-2	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	20890-0050-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	20890-0050-3	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	20890-0050-2	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	20890-0050-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	20890-0050-3	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	20890-0050-2	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	20890-0050-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	20890-0050-3	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	20890-0050-2	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	20890-0050-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	20890-0050-3	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	20890-0050-2	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	20890-0050-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	20890-0050-3	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	20890-0050-2	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	20890-0050-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	20890-0050-3	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	20890-0050-2	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	20890-0050-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	20890-0050-3	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	20890-0050-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	20890-0050-3	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	20890-0050-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	20890-0050-3	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	20890-0050-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
20890-0050-1	2023-01-30	C162847	48780-1	f386c649-be33-0266-e053-dadaa90a7c1a	TopCare ® Amber Antibacterial Hand Soap
20890-0050-2	2023-01-30	C162847	48780-1	f386c649-be33-0266-e053-dadaa90a7c1a	TopCare ® Amber Antibacterial Hand Soap
20890-0050-3	2023-01-30	C162847	48780-1	f386c649-be33-0266-e053-dadaa90a7c1a	TopCare ® Amber Antibacterial Hand Soap

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Benzalkonium Chloride	ACTIVE INGREDIENT	F5UM2KM3W7	TOPCARE AMBER ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [ABACO PARTNERS LLC DBA SUREFIL]	1
Benzalkonium	ACTIVE MOIETY	7N6JUD5X6Y	TOPCARE AMBER ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [ABACO PARTNERS LLC DBA SUREFIL]	1
Cetrimonium Chloride	INACTIVE INGREDIENT	UC9PE95IBP	TOPCARE AMBER ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [ABACO PARTNERS LLC DBA SUREFIL]	1
Citric Acid Monohydrate	INACTIVE INGREDIENT	2968PHW8QP	TOPCARE AMBER ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [ABACO PARTNERS LLC DBA SUREFIL]	1
Coco Monoethanolamide	INACTIVE INGREDIENT	C80684146D	TOPCARE AMBER ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [ABACO PARTNERS LLC DBA SUREFIL]	1
Edetate Sodium	INACTIVE INGREDIENT	MP1J8420LU	TOPCARE AMBER ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [ABACO PARTNERS LLC DBA SUREFIL]	1
FD&C Red No. 4	INACTIVE INGREDIENT	X3W0AM1JLX	TOPCARE AMBER ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [ABACO PARTNERS LLC DBA SUREFIL]	1
FD&C Yellow No. 5	INACTIVE INGREDIENT	I753WB2F1M	TOPCARE AMBER ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [ABACO PARTNERS LLC DBA SUREFIL]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	TOPCARE AMBER ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [ABACO PARTNERS LLC DBA SUREFIL]	1
Lauramidopropylamine Oxide	INACTIVE INGREDIENT	I6KX160QTV	TOPCARE AMBER ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [ABACO PARTNERS LLC DBA SUREFIL]	1
MethylChloroisothiazolinone	INACTIVE INGREDIENT	DEL7T5QRPN	TOPCARE AMBER ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [ABACO PARTNERS LLC DBA SUREFIL]	1
Methylisothiazolinone	INACTIVE INGREDIENT	229D0E1QFA	TOPCARE AMBER ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [ABACO PARTNERS LLC DBA SUREFIL]	1
PEG-120 Methyl Glucose Dioleate	INACTIVE INGREDIENT	YM0K64F20V	TOPCARE AMBER ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [ABACO PARTNERS LLC DBA SUREFIL]	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	TOPCARE AMBER ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [ABACO PARTNERS LLC DBA SUREFIL]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	TOPCARE AMBER ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [ABACO PARTNERS LLC DBA SUREFIL]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
20890-0050-1	20890005001	221 mL in 1 BOTTLE, PUMP (20890-0050-1)	221 ml	2014-12-15	0000-00-00	No	No	Current
20890-0050-3	20890005003	1650 mL in 1 BOTTLE, PLASTIC (20890-0050-3)	1650 ml	2014-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TopCare ® Amber Antibacterial Hand Soap	Abaco Partners LLC DBA Surefil	2021-12-27	HUMAN OTC DRUG LABEL	3

TopCare Amber Antibacterial Hand

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#