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 56 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
T-Relief Lidocaine HCL 4%	LIDOCAINE HCL 4%	Medinatura New Mexico Inc.	3c19aff8-fb18-78d0-e063-6294a90a9481	2025-12-11	Warnings	Exact identifier application number: M017
Jointiva	TROLAMINE SALICYLATE 10%	Rising Pharma Holdings, Inc.	3ee33cbf-7c0f-4982-b0b6-eeeb0202803b	2025-12-11	Warnings	Exact identifier application number: M017
LMX4	LIDOCAINE	Ferndale Laboratories, Inc.	f0e7c92f-8b0b-4045-b659-af9f6e81260f	2025-12-10	Warnings	Exact identifier application number: M017
HurriCaine One	TOPICAL ANESTHETIC AND ANTISEPTIC	Beutlich Pharmaceuticals LLC	459cedbd-9b6f-e450-e063-6394a90afb73	2025-12-10	Warnings	Exact identifier application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 3	NICOTINE TRANSDERMAL PATCHES	PCHEERY LLC	45811e83-8d0b-bc2a-e063-6294a90adf50	2025-12-09	Warnings	Exact identifier application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 2	NICOTINE TRANSDERMAL PATCHES	PCHEERY LLC	4580d7f0-92a9-d0d0-e063-6394a90ac393	2025-12-09	Warnings	Exact identifier application number: M017
LidoGuard	LIDOCAINE HCL	ALAINA HEALTHCARE PRIVATE LIMITED	c339dffe-bc9b-4fae-a50f-8db463d244c1	2025-12-09	Warnings	Exact identifier application number: M017
Capsaicin Cream 0.075%	CAPSAICIN	ALAINA HEALTHCARE PRIVATE LIMITED	33e861bd-bb92-4aea-9d4d-1b8847c794fd	2025-12-09	Warnings	Exact identifier application number: M017
Methyl Salicylate	METHYL SALICYLATE	ALAINA HEALTHCARE PRIVATE LIMITED	e07c5ebc-5497-4c45-acc5-d12e72e98f3f	2025-12-09	Warnings	Exact identifier application number: M017
Ultra Strength Pain Relief Balm	CAMPHOR, MENTHOL	ALAINA HEALTHCARE PRIVATE LIMITED	80779d1f-0c2a-4ae5-9ed7-eb6877f734ba	2025-12-09	Warnings	Exact identifier application number: M017
Pain Relief Balm	MENTHOL AND CAMPHOR	ALAINA HEALTHCARE PRIVATE LIMITED	12d76b8f-4b1d-4f2d-9722-0adb55093cc4	2025-12-09	Warnings	Exact identifier application number: M017
Trojan Extended Pleasure	BENZOCAINE	Church & Dwight Co., Inc.	be731682-4174-649a-e053-2a95a90a3987	2025-12-09	Warnings	Exact identifier application number: M017
Stopain Clinical Continuous	MENTHOL	Troy Manufacturing, Inc.	65f8d212-0f0e-4893-b6af-bd68bba46443	2025-12-09	Warnings	Exact identifier application number: M017
Pain and Itch Relief 4% Lidocaine	LIDOCAINE	Walgreens	f84e76a9-6af6-4fd1-be4e-efa05728cbfd	2025-12-09	Warnings	Exact identifier application number: M017
Capsimide	CAPSAICIN 0.025% TOPICAL PATCH	Sola Pharmaceuticals	e81c2de8-6429-d681-e053-2995a90a36a9	2025-12-08	Warnings	Exact identifier application number: M017
Extra Strength Cold-Hot Medicated Patches	MENTHOL	Cardinal Health, 110 dba LEADER	a2895c03-747c-4220-8052-4f0428062622	2025-12-08	Warnings	Exact identifier application number: M017
Leader PAIN RELIEF PATCHES	LIDOCAINE	Cardinal Health, 110 dba LEADER	5feae39e-3ab8-4cda-b9e8-dc221aea2417	2025-12-08	Warnings	Exact identifier application number: M017
Pain Relief Patches	CAMPHOR, MENTHOL, METHYL SALICYLATE	Cardinal Health, 110 dba LEADER	f8837b69-8d85-448c-a4b4-be911bca1f6c	2025-12-08	Warnings	Exact identifier application number: M017
CAPSAICIN HOT PATCHES	CAPSAICIN	Cardinal Health, 110 dba LEADER	76e6bc39-643c-4264-8d98-0e4fa7d778e2	2025-12-08	Warnings	Exact identifier application number: M017
Leader PAIN RELIEF PATCHES	LIDOCAINE	Cardinal Health, 110 dba LEADER	3be6defd-f429-4dc7-8b37-5910705c0b81	2025-12-08	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