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 33 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tylenol Precise Cooling Pain Relieving	LIDOCAINE, MENTHOL	Kenvue Brands LLC	fc0a3404-b174-3952-e053-6294a90a1e02	2026-02-16	Warnings	Exact identifier application number: M017
Aloe Vera Gel	LIDOCAINE HCL	Valu Merchandisers Company	87ee2b4f-d640-4cec-9f48-1d8aa54434e9	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M017
Hemp Magic Fast-Acting Pain Relief Cream	MENTHOL	Nexxus Capital LLC	4af69640-1413-868b-e063-6394a90a3989	2026-02-16	Warnings	Exact identifier application number: M017
RelaxInk LIDOCAINE	LIDOCAINE 4%	Hambli Limited	49a1cf66-9bb1-b918-e063-6394a90a2ff6	2026-02-15	Warnings	Exact identifier application number: M017
blue goo Pain Relieving	MENTHOL 2.5%	Garcoa, Inc.	7b9b5ac6-9568-464c-8096-0302a1e650df	2026-02-13	Warnings	Exact identifier application number: M017
Methyl Salicylate 30 Percent Cream	METHYL SALICYLATE	Alexso, Inc	1d50ccb2-1a5d-49c7-8524-2f54eed63e85	2026-02-13	Warnings	Exact identifier application number: M017
Antiseptic Mouth Rinse	EUCALYPTOL, MENTHOL, METHYOL SALICYLATE, THYMOL	Topco Associates LLC	a38e91c1-7ac6-4a7f-a5a2-8d9166b1535a	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M017
Gel Cooling Pain Relief	MENTHOL	Topco Associates LLC	80962394-a46f-48fd-8e0c-685dd1e500d7	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M017
Banophen	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Major Pharmaceuticals	9758d886-bd58-4eb2-a827-fa8e7fee2b7c	2026-02-13	Warnings	Exact identifier application number: M017
Natureplex Hydrocortisone Hydro	HYDROCORTISONE	Natureplex, LLC	2fc6a148-34bb-4289-8588-32c1bb011b98	2026-02-13	Warnings	Exact identifier application number: M017
Capsaicin 0.035 Percent	CAPSAICIN	Alexso, Inc	6d0bc1cc-e812-4753-b20c-c0357dd6deb5	2026-02-13	Warnings	Exact identifier application number: M017
Swiftalyn Numbing Cream	LIDOCAINE 4%	GENUINE INNOVATION LTD	3f74c4a6-26f0-ddf7-e063-6394a90a1225	2026-02-12	Warnings	Exact identifier application number: M017
PHARMBANNER Arnica Bruise Cream	ARNICA BRUISE CREAM	Shenzhen Xinxin Yunhai Technology Co., Ltd.	3c783061-8e2d-8a84-e063-6394a90a5265	2026-02-12	Warnings	Exact identifier application number: M017
ETERNAL SPIRIT BEAUTY PAIN RELIEF WITH HEMP	MENTHOL, CAMPHOR	Worldwide Cosmetics, Inc	459d64a9-0538-57c8-e063-6394a90a6155	2026-02-12	Warnings	Exact identifier application number: M017
Antiseptic Mouth Rinse	EUCALYPTOL	Walgreen Co.	cba60e9d-5f12-4c56-9fa5-6ce1514fc2b0	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M017
Medicated Body Powder	MENTHOL	Walmart Stores Inc	afd337b7-d76e-f17a-e053-2a95a90abac7	2026-02-12	Warnings	Exact identifier application number: M017
Lidocaine Hydrochloride 2%	LIDOCAINE HYDROCHLORIDE	Aldermed Inc.	4977b722-d08d-3d9e-e063-6294a90a9035	2026-02-12	Warnings	Exact identifier application number: M017
Ice Gel ICE COLD ANALGESIC	MENTHOL	Jell Pharmaceuticals Pvt Ltd	4a8b3f84-8c45-eb94-e063-6394a90a3e73	2026-02-11	Warnings	Exact identifier application number: M017
Walgreens Pain Relieving Lidocaine Patch	LIDOCAINE	Walgreen Co.	41c4e9fe-e407-b22a-e063-6394a90a4b27	2026-02-10	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE CREAM 1%	Aldermed Inc.	4a7f2c0e-5cf3-29cb-e063-6394a90a5d8d	2026-02-10	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