TopCare

Product NDC: 36800-114
11-digit product format: 368000114
Labeler code: 36800
Product ID: 36800-114_a97a97b4-c365-41d9-b322-0d29ca822b05
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium Chloride
Dosage form: LIQUID
Route: TOPICAL
Labeler: TopCo Associates LLC
Application: part333E
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2017-06-13
Marketing end: 0000-00-00
Substance: BENZALKONIUM CHLORIDE
Active strength: 1 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	36800-114		I	Inactivated by FDA	2026-10-05
excluded product	product	36800-114		I	Inactivated by FDA	2026-10-05
excluded package	package	36800-114	36800-114-08	I	Inactivated by FDA	2026-10-05
excluded package	package	36800-114	36800-114-07	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 · 84 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36800-114-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36800-114-08	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36800-114-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36800-114-08	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	36800-114-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	36800-114-08	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	36800-114-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	36800-114-08	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	36800-114-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	36800-114-08	`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 product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36800-114-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36800-114-08	`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 product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36800-114-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36800-114-08	`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 product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36800-114-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36800-114-08	`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 product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36800-114-07	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36800-114-08	`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 product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36800-114-07	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36800-114-08	`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 product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36800-114-07	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36800-114-08	`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 product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36800-114-07	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36800-114-08	`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 product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	36800-114-07	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	36800-114-08	`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 product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	36800-114-07	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	36800-114-08	`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 product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	36800-114-07	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	36800-114-08	`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
36800-114-07	2020-01-31	C162847	48780-1	9d75b9d0-8c9b-f424-e053-dadaa90a57ce	Drug Facts
36800-114-08	2020-01-31	C162847	48780-1	9d75b9d0-1b82-f424-e053-dadaa90a57ce	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-114-07	TopCareAntibacterial Foaming Hand Fresh Water	222 mL in 1 BOTTLE, PLASTIC	LIQUID	222		1
36800-114-08	TOPCAREANTIBACTERIAL FOAMING HAND FRESH WATER	222 mL in 1 BOTTLE, PLASTIC	LIQUID	222		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZALKONIUM CHLORIDE	ACTIVE INGREDIENT	F5UM2KM3W7	TOPCARE ANTIBACTERIAL FOAMING HAND FRESH WATER (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
BENZALKONIUM	ACTIVE MOIETY	7N6JUD5X6Y	TOPCARE ANTIBACTERIAL FOAMING HAND FRESH WATER (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	TOPCARE ANTIBACTERIAL FOAMING HAND FRESH WATER (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	TOPCARE ANTIBACTERIAL FOAMING HAND FRESH WATER (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	TOPCARE ANTIBACTERIAL FOAMING HAND FRESH WATER (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
DECYL GLUCOSIDE	INACTIVE INGREDIENT	Z17H97EA6Y	TOPCARE ANTIBACTERIAL FOAMING HAND FRESH WATER (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	TOPCARE ANTIBACTERIAL FOAMING HAND FRESH WATER (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
EXT. D&C VIOLET NO. 2	INACTIVE INGREDIENT	G5UX3K0728	TOPCARE ANTIBACTERIAL FOAMING HAND FRESH WATER (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TOPCARE ANTIBACTERIAL FOAMING HAND FRESH WATER (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TOPCARE ANTIBACTERIAL FOAMING HAND FRESH WATER (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	TOPCARE ANTIBACTERIAL FOAMING HAND FRESH WATER (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	TOPCARE ANTIBACTERIAL FOAMING HAND FRESH WATER (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	TOPCARE ANTIBACTERIAL FOAMING HAND FRESH WATER (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)	INACTIVE INGREDIENT	0L414VCS5Y	TOPCARE ANTIBACTERIAL FOAMING HAND FRESH WATER (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	TOPCARE ANTIBACTERIAL FOAMING HAND FRESH WATER (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	TOPCARE ANTIBACTERIAL FOAMING HAND FRESH WATER (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOPCARE ANTIBACTERIAL FOAMING HAND FRESH WATER (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	TOPCARE ANTIBACTERIAL FOAMING HAND FRESH WATER (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-114	TOPCARE ANTIBACTERIAL FOAMING HAND FRESH WATER (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1	Legacy NDC, 1 package rows	20140730_e2f6381a-e4cc-44ef-8a9b-c221ba780500.zip
36800-114	TOPCARE ANTIBACTERIAL FOAMING HAND FRESH WATER (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]	1	Legacy NDC, 1 package rows	20170614_f07fad0d-3a73-4005-9ddc-5198a0d303e8.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1046593	benzalkonium chloride 0.13 % Medicated Liquid Soap	PSN	e2f6381a-e4cc-44ef-8a9b-c221ba780500	1
1046593	benzalkonium chloride 0.13 % Medicated Liquid Soap	PSN	f07fad0d-3a73-4005-9ddc-5198a0d303e8	1
1046593	benzalkonium chloride 1.3 MG/ML Medicated Liquid Soap	SCD	e2f6381a-e4cc-44ef-8a9b-c221ba780500	1
1046593	benzalkonium chloride 1.3 MG/ML Medicated Liquid Soap	SCD	f07fad0d-3a73-4005-9ddc-5198a0d303e8	1
1046593	benzalkonium chloride 0.13 % Medicated Liquid Soap	SY	e2f6381a-e4cc-44ef-8a9b-c221ba780500	1
1046593	benzalkonium chloride 0.13 % Medicated Liquid Soap	SY	f07fad0d-3a73-4005-9ddc-5198a0d303e8	1
1046593	benzalkonium chloride 1.33 MG/ML Medicated Liquid Soap	SY	e2f6381a-e4cc-44ef-8a9b-c221ba780500	1
1046593	benzalkonium chloride 1.33 MG/ML Medicated Liquid Soap	SY	f07fad0d-3a73-4005-9ddc-5198a0d303e8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
36800-114-07	36800011407	222 mL in 1 BOTTLE, PLASTIC	222 ml	Historical
36800-114-08	36800011408	222 mL in 1 BOTTLE, PLASTIC	222 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	TopCo Associates LLC \| Apollo Health and Beauty Care Inc.	2017-04-18	HUMAN OTC DRUG LABEL	1
DRUG FACTS	TOPCO ASSOCIATES LLC \| APOLLO HEALTH AND BEAUTY CARE	2014-07-25	HUMAN OTC DRUG LABEL	1