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 127 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Caring Mill Anti-Itch Cream	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Veridian Healthcare	22ca137a-576c-a13c-e063-6394a90ae7fc	2024-09-23	Warnings	Exact identifier application number: M017
Signature Care Anti Itch	HYDROCORTISONE	Safeway	ed0eb068-3ce6-423d-a7f8-c3456b7f6040	2024-09-23	Warnings	Exact identifier application number: M017
members mark hydrocortisone	HYDROCORTISONE	Sam's West Inc	218f0dcd-fa67-4935-8019-ecbbd53ed2f7	2024-09-23	Warnings	Exact identifier application number: M017
anti itch	HYDROCORTISONE	Meijer, Inc.	a07496e0-6fc2-4190-8a01-f513134ffb92	2024-09-23	Warnings	Exact identifier application number: M017
ZYLOTROL PAIN RELIEVING	LIDOCAINE HCL, MENTHOL	Whitestone Products LLC	2301fed7-0fa9-450d-8b1b-006f53235be0	2024-09-21	Warnings	Exact identifier application number: M017
Tibetree Cheezheng Joint Analgesic Patch	CAMPHOR	Tibet Cheezheng Tibetan Medicine Co. Ltd	65a8a63f-1864-473e-be72-7840a6a5dee7	2024-09-20	Warnings	Exact identifier application number: M017
Cold Ice Analgesic Gel	MENTHOL	Dabur India Limited	22915b2f-5f76-3e38-e063-6394a90a07b4	2024-09-20	Warnings	Exact identifier application number: M017
Exchange Select Hydrocortisone	HYDROCORTISONE	Army & Air Force Exchange Service	1b709db3-7dc1-4756-a8a0-dddda875dc57	2024-09-19	Warnings	Exact identifier application number: M017
Lidocaine	LIDOCAINE	Stratus Pharmaceuticals Inc	e1a8d4a7-01f7-4bab-8d09-875c461b3b61	2024-09-19	Warnings	Exact identifier application number: M017
Camphor Spirit	CAMPHOR 10%	Strategic Sourcing Services, LLC	2216d799-7f6f-cab7-e063-6294a90a8d6c	2024-09-14	Warnings	Exact identifier application number: M017
Meijer Analgesic Lidocaine Topical Analgesic	LIDOCAINE HYDROCHLORIDE	Meijer Distribution, Inc	f5d39be6-3b91-4ba1-9015-fd3ffbbdf4aa	2024-09-12	Warnings	Exact identifier application number: M017
leader anti itch	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Cardinal Health 110, LLC. dba Leader	e1aab35b-80d9-4515-afb7-8c662bc5d028	2024-09-11	Warnings	Exact identifier application number: M017
LactiGo	MENTHOL	LactiGo, Inc.	849c3601-2bc8-0991-e053-2a91aa0a5e7f	2024-09-03	Warnings	Exact identifier application number: M017
Hempvana Ultra Strength Pain Relief Gel Platinum - Arthritis	MENTHOL 8%	Telebrands Corp	c22cf1a5-0d5d-5ea5-e053-2995a90a333b	2024-09-02	Warnings	Exact identifier application number: M017
Itch and Rash Cream	HYDROCORTISONE	Wildman Business Group	1f95757d-a434-f02a-e063-6294a90a2d12	2024-09-01	Warnings	Exact identifier application number: M017
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Wildman Business Group	1fd1a4b3-b6fd-0d4c-e063-6394a90a3680	2024-09-01	Warnings	Exact identifier application number: M017
Thera Care Cold Hot Medicated Patch	MENTHOL	Veridian Healthcare	b1ce129d-06a1-7755-e053-2995a90abd7d	2024-08-29	Warnings	Exact identifier application number: M017
BIOSAVIA External Analgesic Pain Relief	CAPSAICIN	BIOSAVIA USA, LLC	814aa66b-7719-4a29-a84e-18290367e9c7	2024-08-28	Warnings	Exact identifier application number: M017
Careland Plantar Fasciitis Hydrogel Pain Patches	LIDOCAINE, MENTHOL	Planet (Anhui) Pharmaceutical Co., Ltd.	0e2f29c2-2e95-4be0-b7e9-f1761a1321a5	2024-08-21	Warnings	Exact identifier application number: M017
Careland Max Strength Lidocaine 4 Pain Relieving	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	265b8dd7-64a4-4bc2-a91c-26c761c2090b	2024-08-21	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