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 53 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZIMS MAX FREEZE	LIDOCAINE HYDROCHLORIDE AND MENTHOL,	KOBAYASHI Healthcare International, Inc.	e364ff83-4aaf-4897-a7da-06581bc321f2	2025-12-18	Warnings	Exact identifier application number: M017
Tiger Balm White Regular Strength	CAMPHOR (SYNTHETIC) AND MENTHOL	Haw Par Healthcare Ltd.	f406161e-a9c4-47d1-8b21-93b1b7938063	2025-12-17	Warnings	Exact identifier application number: M017
Resinol	PETROLATUM AND RESORCINOL	ResiCal, Inc.	03f57a4a-f94b-4ba6-b709-41cfb6e16261	2025-12-17	Warnings	Exact identifier application number: M017
HealthWise Maximum Pain Relief	LIDOCAINE	Veridian Healthcare	afc3c16d-0076-44b2-ae7e-5f36d4d8088e	2025-12-17	Warnings	Exact identifier application number: M017
HealthWise Max Lidocaine plus Menthol	LIDOCAINE, MENTHOL	Veridian Healthcare	f39a27da-6799-4fc6-97ca-101eac4a9360	2025-12-17	Warnings	Exact identifier application number: M017
HealthWise Original Menthol	MENTHOL	Veridian Healthcare	e4bfb6b0-545e-4fbc-8538-4f41a6be1025	2025-12-17	Warnings	Exact identifier application number: M017
Welly Polka First Aid Kit	HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Dongguan Shenglian Tins Products Co., Ltd.	d7c4314c-c4c6-4adf-b384-3ac7a7108319	2025-12-17	Warnings	Exact identifier application number: M017
Frankincense and Myrrh Arthritis Pain Therapy	MENTHOL	Wise Consumer Products	2410a199-f4a3-da6c-e063-6394a90aaace	2025-12-17	Warnings	Exact identifier application number: M017
Lidocaine	LIDOCAINE, MENTHOL	Vive Health LLC	462d3b24-643e-91da-e063-6394a90a0e1d	2025-12-17	Warnings	Exact identifier application number: M017
Theragesic	METHYL SALICYLATE	Mission Pharmacal Company	db6c0c77-0a20-d574-a98f-e6c9998b941f	2025-12-17	Warnings	Exact identifier application number: M017
Teevodar Pain Relieving	MENTHOL	Sod-e Biotech Ltd	205b0fef-4f00-db2e-e063-6294a90a93b8	2025-12-17	Warnings	Exact identifier application number: M017
Frankincense and Myrrh Arthritis Pain Relief	MENTHOL	WISE CONSUMER PRODUCTS CO.	116045df-891b-f370-e063-6294a90abe42	2025-12-17	Warnings	Exact identifier application number: M017
Frankincense and Myrrh Intensive Foot Therapy	MENTHOL	Wise Consumer Products	23e56c6b-0f2b-721f-e063-6394a90a1ed0	2025-12-17	Warnings	Exact identifier application number: M017
Tiger Balm Ultra Strength	CAMPHOR (SYNTHETIC) AND MENTHOL	Haw Par Healthcare Ltd.	f0561804-e0f7-495d-9768-9b86a208c51e	2025-12-17	Warnings	Exact identifier application number: M017
Kwan Loong	METHYL SALICYLATE AND MENTHOL	Haw Par Healthcare Ltd.	54bcb26e-786a-403e-9330-11ae9e3c013a	2025-12-17	Warnings	Exact identifier application number: M017
Magsoothium Body Cooling Formula	MENTHOL	Ubu/Elements, Inc.	f7fb6ac9-a920-a440-e053-6394a90aaa35	2025-12-16	Warnings	Exact identifier application number: M017
Magsoothium CBD Body Lavender	MENTHOL	Ubu/Elements, Inc.	f9b87fbe-b889-67a1-e053-6394a90acbcd	2025-12-16	Warnings	Exact identifier application number: M017
Aquaphor Itch Relief	HYDROCORTISONE	Beiersdorf Inc	b1d0333f-ba60-35d8-e053-2995a90af932	2025-12-16	Warnings	Exact identifier application number: M017
Magsoothium CBD Body	MENTHOL	Ubu/Elements, Inc.	00b2ef34-42d7-523c-e063-6294a90a753d	2025-12-16	Warnings	Exact identifier application number: M017
GENTLECARE HAND AND SKIN SANITIZER	BENZALKONIUM CHLORIDE	PARAGON SOLUTIONS US, INC.	16650277-fa62-485e-9a82-7763d2b50168	2025-12-16	Warnings	Exact identifier application number: M017 ndc (product): 78181-020

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