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 83 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Neighbor Roll-on Pain Relief	LIDOCAINE HCL	Amerisource Bergen	a0c3adbf-fa35-47c0-9db3-459ce9a106ac	2025-08-06	Warnings	Exact identifier application number: M017
Good Neighbor Roll-on Menthol Pain Relief Gel	MENTHOL	Amerisource Bergen	bd557323-0003-4ee6-b22d-a72d621c7de4	2025-08-05	Warnings	Exact identifier application number: M017
Earthmed FS Pain relieving balm	MENTHOL	Earthmed LLC	3ba4e769-fec6-52d9-e063-6394a90a65d4	2025-08-05	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE	HF Acquisition Co LLC, DBA HealthFirst	3ba6a5ec-fda2-b2a6-e063-6294a90ac9b6	2025-08-05	Warnings	Exact identifier application number: M017
Kocowo Lidocaine Pain Relief Gel-Patch	LIDOCAINE PAIN RELIEF GEL-PATCH	Henan Enokon Medical Instrument Co., Ltd.	3b82989d-7cc3-23d3-e063-6294a90ae2a3	2025-08-03	Warnings	Exact identifier application number: M017
Menthol pain relief patches	MENTHOL	Menthol pain relief patch	3b5fd718-3f86-f7a7-e063-6294a90a8c52	2025-08-02	Warnings	Exact identifier application number: M017
Graphene Far Infrared Herbal Pain Relief Patches	CORYDALIS RHIZOME	Changsha Maocheng Trading Co., Ltd	3b604a3c-fe91-7096-e063-6394a90afe04	2025-08-02	Warnings	Exact identifier application number: M017
Active Recovery Pain Relief	CAMPHOR, MENTHOL	Charlotte's Web, Inc.	3a9f9ca0-3d8a-796a-e063-6394a90a790c	2025-08-01	Warnings	Exact identifier application number: M017
Active Recovery Pain Relief Stick	CAMPHOR, MENTHOL	Charlottes Web, Inc.	3aa037c6-6109-b52e-e063-6394a90a215b	2025-08-01	Warnings	Exact identifier application number: M017
PM Recovery Pain Relief	CAMPHOR, MENTHOL	Charlotte's Web, Inc.	3aa08859-809d-de8c-e063-6394a90a8e25	2025-08-01	Warnings	Exact identifier application number: M017
Wish ultra winter ice	MENTHOL	LJ Pharma	b4c5487c-1314-4d63-96df-077e72e7ee95	2025-08-01	Warnings	Exact identifier application number: M017
Rugged Fit Pain Relief Roll On	MENTHOL, METHYL SALICYLATE	SYSTEM4BOOK LLC	39d68734-981c-14d7-e063-6294a90a4919	2025-08-01	Warnings	Exact identifier application number: M017
ICY FREEZE	MENTHOL, UNSPECIFIED FORM	Natural Essentials, Inc.	28fdb049-b297-4358-9447-7d69ba879702	2025-08-01	Warnings	Exact identifier application number: M017
Cortizone 10 Cooling	HYDROCORTISONE	Chattem, Inc.	14d9fce2-9f54-4204-83cb-161de8a303f0	2025-08-01	Warnings	Exact identifier application number: M017
Bravado Labs Numbing	LIDOCAINE HCL	Prodigy Media Inc	8c43f5b5-b911-4a7a-b2d1-56a09c54b001	2025-07-30	Warnings	Exact identifier application number: M017
Chimera GUARD	LIDOCAINE PAIN RELIEFING PATCH	Hangzhou Rongna Health Technology Co., Ltd.	3721c984-1993-6265-e063-6394a90af23f	2025-07-29	Warnings	Exact identifier application number: M017
Chimera GUARD	LIDOCAINE PAIN RELIEFING PATCH	Hangzhou Rongna Health Technology Co., Ltd.	3758d625-010f-7441-e063-6394a90a066d	2025-07-29	Warnings	Exact identifier application number: M017
Cold Therapy Roll on	COLD THERAPY ROLL ON	Allegiant Health	36463acb-7c28-416f-a45f-a93f0be5692b	2025-07-29	Warnings	Exact identifier application number: M017
ProCure Anti Itch	CAMPHOR 0.5%	Twin Med LLC	3afe387c-ef42-215d-e063-6394a90a41b5	2025-07-28	Warnings	Exact identifier application number: M017
lidocaine pain relief patches	LIDOCAINE	Changsha Maocheng Trading Co., Ltd	3afeead3-4f5c-4711-e063-6294a90aacca	2025-07-28	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