GENTLECARE HAND AND SKIN SANITIZER

Product NDC: 78181-020
11-digit product format: 781810020
Labeler code: 78181
Product ID: 78181-020_46181bb4-3d7b-f7cc-e063-6394a90a3033
Type: HUMAN OTC DRUG
Nonproprietary name: BENZALKONIUM CHLORIDE
Dosage form: LIQUID
Route: TOPICAL
Labeler: PARAGON SOLUTIONS US, INC.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-04-01
Substance: BENZALKONIUM CHLORIDE
Active strength: 1.3 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 15 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
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	78181-020-18	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	78181-020-07	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	78181-020-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	78181-020-28	`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	78181-020-18	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	78181-020-07	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	78181-020-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	78181-020-28	`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	78181-020-18	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	78181-020-07	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	78181-020-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	78181-020-28	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: GENTLECARE HAND AND SKIN SANITIZER
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZALKONIUM CHLORIDE	1.3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F5UM2KM3W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1020365	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
16650277-fa62-485e-9a82-7763d2b50168	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78181-020-02	GENTLECARE HAND AND SKIN SANITIZER	50 mL in 1 BOTTLE, PUMP	LIQUID	50	8
78181-020-07	GENTLECARE HAND AND SKIN SANITIZER	221 mL in 1 BOTTLE, PUMP	LIQUID	221	8
78181-020-18	GENTLECARE HAND AND SKIN SANITIZER	550 mL in 1 BOTTLE, PUMP	LIQUID	550	8
78181-020-28	GENTLECARE HAND AND SKIN SANITIZER	3785 mL in 1 JUG	LIQUID	3785	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78181-020	GENTLECARE HAND AND SKIN SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [PARAGON SOLUTIONS US, INC.]	7	Current NDC, Legacy NDC, 4 package rows	20241215_16650277-fa62-485e-9a82-7763d2b50168.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 142 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tact Cool Jelly	DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL	Sato Pharmaceutical Co., Ltd.	f34872c9-91b9-49db-8e41-5b54a069284a	2023-12-01	Warnings	Exact identifier application number: M017
Satohap	METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL	Sato Pharmaceutical Co., Ltd.	348fde05-2797-4410-a1b2-99e64187c4fe	2023-12-01	Warnings	Exact identifier application number: M017
Menthozen Hydrogel	MENTHOL, CAPSAICIN	Proficient Rx LP	85a7809e-c43f-4138-a85b-44e1b586def5	2023-12-01	Warnings	Exact identifier application number: M017
Menthozen Cream	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Proficient Rx LP	66681906-c5f5-4c57-bb43-9c83cccc0062	2023-12-01	Warnings	Exact identifier application number: M017
Lidozen Patch	LIDOCAINE, MENTHOL	Proficient Rx LP	c0df4b8b-2679-4652-9144-a8db916a186b	2023-12-01	Warnings	Exact identifier application number: M017
Lidozen Gel	LIDOCAINE HYDROCHLORIDE, MENTHOL	Proficient Rx LP	7c300dec-cefd-4b79-a948-a917b7708a04	2023-12-01	Warnings	Exact identifier application number: M017
Menthozen	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Proficient Rx LP	2adf3c4d-636f-4e02-b501-946b4df5f5d6	2023-12-01	Warnings	Exact identifier application number: M017
Lidozen	LIDOCAINE, MENTHOL	Proficient Rx LP	488d665c-a4fe-4a69-bab3-34b2347f4b05	2023-12-01	Warnings	Exact identifier application number: M017
Thera Plus Max Strength Lidocaine Pain Relief Liquid	LIDOCAINE HYDROCHLORIDE	Fourstar Group USA, Inc.	0a228b06-0e1c-6c75-e063-6294a90a9a0e	2023-11-30	Warnings	Exact identifier application number: M017
Thera Plus Cool and Heat Pain Relieving Gel Menthol	MENTHOL	Fourstar Group USA, Inc.	0a225714-ccb1-4676-e063-6294a90aeeb2	2023-11-30	Warnings	Exact identifier application number: M017
Bloop Itch Soothing Topical	HYDROCORTISONE	Three Nations Corp	0b64677e-d4bf-0929-e063-6294a90af137	2023-11-30	Warnings	Exact identifier application number: M017
Ice Quake	MENTHOL	Southern Sales & Service, Inc.	7a05832f-49ac-4013-b240-4405501e45cd	2023-11-29	Warnings	Exact identifier application number: M017
ICE MUSCLE RUB Leon M.C	MENTHOL	Southern Sales & Service, Inc.	4efaf347-7406-4690-8005-e7cf2e3d4222	2023-11-29	Warnings	Exact identifier application number: M017
IceQuake Analgestic White	METHYL SALICYLATE, MENTHOL	Southern Sales & Service, Inc.	54e5dcd5-9987-488d-a758-d0e76d155182	2023-11-29	Warnings	Exact identifier application number: M017
Icequake Coldn Hot medicated patch	MENTHOL	Southern Sales & Service, Inc.	89202c52-9eb7-4e5a-a709-4a66ab0d3a72	2023-11-29	Warnings	Exact identifier application number: M017
IceQuake Lidocaine Analgesic	LIDOCAINE HYDROCHLORIDE	Southern Sales & Service, Inc.	9089cb78-e9f8-4437-a767-df809a114c4b	2023-11-29	Warnings	Exact identifier application number: M017
Ice Quake Muscle Rub Blue	MENTHOL	Southern Sales & Service, Inc.	5180f6a3-58f1-4c50-a33b-7d85a3c1b99b	2023-11-29	Warnings	Exact identifier application number: M017
Discount Drug Mart Extra Strength Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Discount Drug Mart	8579df23-ac07-9df8-e053-2991aa0a8bbb	2023-11-29	Warnings	Exact identifier application number: M017
Satohap	METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL	Sato Pharmaceutical Co., Ltd.	3a2fc8ae-f1ac-4c64-8e75-d5fdb141aecf	2023-11-28	Warnings	Exact identifier application number: M017
Poli-A	HYDROCORTISONE ACETATE	Sato Pharmaceutical Co., Ltd.	e27a3840-d9de-4bd0-ad75-8a151bd12b83	2023-11-28	Warnings	Exact identifier application number: M017

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
1020365	benzalkonium chloride 0.13 % Topical Foam	PSN	16650277-fa62-485e-9a82-7763d2b50168	8
1020365	benzalkonium chloride 1.3 MG/ML Topical Foam	SCD	16650277-fa62-485e-9a82-7763d2b50168	8
1020365	benzalkonium chloride 0.13 % Topical Foam	SY	16650277-fa62-485e-9a82-7763d2b50168	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78181-020-02	78181002002	50 mL in 1 BOTTLE, PUMP (78181-020-02)	50 ml	2020-04-01	0000-00-00	No	No	Current
78181-020-07	78181002007	221 mL in 1 BOTTLE, PUMP (78181-020-07)	221 ml	2020-04-01	0000-00-00	No	No	Current
78181-020-18	78181002018	550 mL in 1 BOTTLE, PUMP (78181-020-18)	550 ml	2020-04-01	0000-00-00	No	No	Current
78181-020-28	78181002028	3785 mL in 1 JUG (78181-020-28)	3785 ml	2020-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BENZALKONIUM CHLORIDE - PARAGON SOLUTIONS US, INC. \| Lifequest Creations LLC	PARAGON SOLUTIONS US, INC. \| Lifequest Creations LLC	2025-12-16	HUMAN OTC DRUG LABEL	8