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 32 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HQLSEY QUIT SMOKING PATCHES	QUIT SMOKING PATCHES	Hansen Pharmaceutical Investment Co., Limited	4ba317fb-714a-05cb-e063-6394a90a382f	2026-02-25	Warnings	Exact identifier application number: M017
Advanced Pain Relief Cream With 5 % Natural Menthol	MENTHOL	Allure Labs	4bab9c43-86d4-dad2-e063-6394a90ac095	2026-02-25	Warnings	Exact identifier application number: M017
Walgreens Pain Relieving Patch	MENTHOL, CAMPHOR, METHYL SALICYLATE	Walgreen Co.	4223c74a-12fb-51a3-e063-6294a90a0deb	2026-02-25	Warnings	Exact identifier application number: M017
Advanced Pain Relief Roll-On Gel With 5% Natural Menthol	MENTHOL	Allure Labs	4bad597f-acb2-a122-e063-6394a90a9fcf	2026-02-25	Warnings	Exact identifier application number: M017
Maximum Strength 4% Lidocaine Patch Good Neighbor Pharmacy	LIDOCAINE	InterMed Laboratories Private Limited	4bade8a9-43bd-b649-e063-6294a90a81da	2026-02-25	Warnings	Exact identifier application number: M017
dermaFIT Muscle Retention Cream Strength	MENTHOL	EX Healthcare Inc.	4620c41a-2187-00f5-e063-6394a90a613c	2026-02-23	Warnings	Exact identifier application number: M017
dermaFIT Muscle Retention Cream Sculpt	MENTHOL	EX Healthcare Inc.	4620d4ca-42e4-eeae-e063-6394a90a5c84	2026-02-23	Warnings	Exact identifier application number: M017
dermaFIT Muscle Retention Cream Extra Strength	MENTHOL	EX Healthcare Inc.	4620ca7a-afe6-d063-e063-6394a90ab5db	2026-02-23	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Sportpharm LLC	9578b39e-3df7-4d75-abd7-f1d5524545e5	2026-02-23	Warnings	Exact identifier application number: M017
0.5% LIDOCAINE BURN RELIEF	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	cf723c7b-495d-4bae-942c-561cf28af2d3	2026-02-21	Warnings	Exact identifier application number: M017
Swiftalyn Numbing Cream	MENTHOL 1%	GENUINE INNOVATION LTD	4b2ebff2-2f50-e54b-e063-6294a90aaccb	2026-02-19	Warnings	Exact identifier application number: M017
Equate Cold Therapy Pain Relieving	MENTHOL	Walmart Inc	46a3c9e9-5cd3-4bc4-e063-6394a90a7178	2026-02-19	Warnings	Exact identifier application number: M017
Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	Meijer, Inc.	e11390ec-99a3-4ff1-a3c8-ca909f4f67b5	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M017
Aloe Vera Gel	LIDOCAINE HCL, MENTHOL	Meijer, Inc.	d0cc06c1-c0d5-42f0-82cd-8b704cbe1f46	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	CHEMCO CORPORATION	4b1a0e6f-aa68-421c-e063-6294a90a426e	2026-02-18	Warnings	Exact identifier application number: M017
Veiurkiu External Analgesic Cream	LIDOCAINE	BLOOMWELL GARDENS LLC	40ec5e6f-13dc-de04-e063-6294a90af5d5	2026-02-18	Warnings	Exact identifier application number: M017
External Analgesic Cream with Menthol 5%	MENTHOL 5%	BLOOMWELL GARDENS LLC	402faa27-5305-c73d-e063-6394a90a36f2	2026-02-18	Warnings	Exact identifier application number: M017
PAINGEL	MENTHOL, METHYL SALICYLATE	NACOR BUSINESS GROUP LLC	4b1d55e2-cf83-ffbd-e063-6294a90ad52f	2026-02-18	Warnings	Exact identifier application number: M017
Alocane Anti-Itch	HYDROCORTISONE 1%	Quest Products, LLC	45252043-d41a-3cdd-e063-6394a90aa9e5	2026-02-18	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Medrock Pharmacy LLC	43e00e17-1a48-43db-9589-834568917bbf	2026-02-17	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