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 74 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nufabrx Medicine Infused Socks	CAPSAICIN	Nufabrx LLC	00d7d5bf-ee03-e73d-e063-6394a90a5d94	2025-10-15	Warnings	Exact identifier application number: M017
Nufabrx Medicine Infused Elbow Sleeve	CAPSAICIN	Nufabrx LLC	27ef3ef0-2f98-6672-e063-6294a90aeca4	2025-10-15	Warnings	Exact identifier application number: M017
Nufabrx Medicine Infused Wrist Sleeve	CAPSAICIN	Nufabrx LLC	22572cf9-fc0c-d327-e063-6394a90a2186	2025-10-15	Warnings	Exact identifier application number: M017
Antibacterial Lidocaine Wound Gel	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	WALGREENS	eff77965-dc7f-49af-e053-2995a90a1a97	2025-10-14	Warnings	Exact identifier application number: M017
Pleasure Balm Kama Sutra	BENZOCAINE	Cosmetic Enterprises Ltd	f370e3c4-65ca-4f3c-a5aa-70e198e681a2	2025-10-14	Warnings	Exact identifier application number: M017
Vanicream HC Anti-Itch	HYDROCORTISONE	Pharmaceutical Specialties, Inc.	28b06507-27a5-2cb1-e054-00144ff8d46c	2025-10-14	Warnings	Exact identifier application number: M017
Trilogel	LIDOCAINE HYDROCHLORIDE	Trifluent Pharma LLC	22af7d63-6a56-4a38-a95b-0f88410b23cb	2025-10-14	Warnings	Exact identifier application number: M017
PROINNATE Numbing Cream	MENTHOL	Guangzhou Haishi Biological Technology Co., Ltd.	40c63645-8ed3-82b3-e063-6294a90a5267	2025-10-13	Warnings	Exact identifier application number: M017
Cramergesic	MENTHOL, METHYL SALICYLATE	The Hygenic Company, LLC	d0ffde7a-6942-74fc-e053-2a95a90a484a	2025-10-13	Warnings	Exact identifier application number: M017
Tricylate	MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE	Trifluent Pharma LLC	4869b63a-e01e-4a79-a493-7a1b4d3e914b	2025-10-13	Warnings	Exact identifier application number: M017
Doloflex Pain Relief	MENTHOL, METHYL SALICYLATE	United Health & Beauty Corp	32a830cc-04d3-102e-e063-6294a90a1cad	2025-10-12	Warnings	Exact identifier application number: M017
Lidocaine Pain Relieving Gel-Patch	LIDOCAINE	Nanjing Anxing Medical Technology Co., Ltd.	40c9b132-57ce-865e-e063-6394a90a2080	2025-10-10	Warnings	Exact identifier application number: M017
Kinesys	ZINC OXIDE	Wilc Healthcare Inc	a32b44c3-eda0-48ea-95fc-250a2c2396ca	2025-10-10	Warnings	Exact identifier application number: M017
Te-Fu Recovery Massage	MENTHOL, METHYL SALICYLATE	Wasatch Product Development	7bc2989f-dfb6-e8af-e053-2991aa0a0bf2	2025-10-10	Warnings	Exact identifier application number: M017
Anti-itch	HYDROCORTISONE	Medline Industries, LP	b0947381-c0db-4253-ab40-3d45603ae65d	2025-10-09	Warnings	Exact identifier application number: M017
Kalaya Pain Relief	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	e2452c4b-2548-497f-828b-5d960402522a	2025-10-08	Warnings	Exact identifier application number: M017
Kalaya Pain Relief 6X with Arnica	PAIN RELIEF CREAM	Avaria Health & Beauty Corp	60198d2e-4de3-3fa0-e053-2a91aa0afaf7	2025-10-08	Warnings	Exact identifier application number: M017
KALAYA PAIN RELIEF 6X WITH ARNICA - Pain Relief	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	9b9b7cad-a5e2-4445-856b-4aa439d77a80	2025-10-08	Warnings	Exact identifier application number: M017
KALAYA FOAMING PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	d5021e6d-f29f-446b-874c-bdcabd9cf4f6	2025-10-08	Warnings	Exact identifier application number: M017
KALAYA EXTRA STRENGTH FOAMING PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	e0c9f22a-165a-4558-ba3c-8592f1bd0016	2025-10-08	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