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 139 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dendracin Neurodendraxcin	METHYL SALICYLATE, MENTHOL AND CAPSAICIN	Proficient Rx LP	7e765fc1-74c6-4af3-a9cf-05b57011d7d8	2024-01-01	Warnings	Exact identifier application number: M017
CeraVe Developed with Dermatologists Itch Relief Moisturizing	PRAMOXINE HYDROCHLORIDE	L'Oreal USA Products Inc	c6a0880e-fc16-46e9-8314-c56c9d15bf31	2023-12-31	Warnings	Exact identifier application number: M017
CeraVe Developed with Dermatologists Anti Itch	HYDROCORTISONE	L'Oreal USA Products Inc.	8d65e945-2557-486f-9279-ecbaa08f31c4	2023-12-31	Warnings	Exact identifier application number: M017
Nighttime Sleep-Aid Non-Habit Forming	DIPHENHYDRAMINE HCI	AptaPharma Inc.	ed0ba7aa-e794-43da-b576-6b9945bf7477	2023-12-30	Warnings	Exact identifier application number: M017
Sting-Kill	BENZOCAINE AND MENTHOL	RANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH	b8bd9280-f20a-4b2a-aef7-a0ba7b3b8701	2023-12-29	Warnings	Exact identifier application number: M017
Maybelline New York Baby Lips Dr Rescue Medicated Balm	MENTHOL	L'Oreal USA Products Inc	2f7b8221-66f6-4aed-8359-318cfc656a72	2023-12-28	Warnings	Exact identifier application number: M017
Equate Cortisone	HYDROCORTISONE 1%	Walmart Inc	027fae33-93a0-a61f-e063-6294a90a990f	2023-12-27	Warnings	Exact identifier application number: M017
Walgreens Cool n Heat Lidocaine	LIDOCAINE HCL 4%	Walgreens Co	0681c6c5-5a8b-ea9e-e063-6394a90a83bc	2023-12-27	Warnings	Exact identifier application number: M017
EXTRA STRENGTH WAL-DRYL ITCH RELIEF	DIPHENHYDRAMINE, ZINC ACETATE	WALGREEN CO	681cf1af-2cc3-4e6d-b76f-f00731ea3e12	2023-12-27	Warnings	Exact identifier application number: M017
XRay Pain Relief	MENTHOL, (PLUS)-, CAMPHOR, (-)-, AND METHYL SALICYLATE	Genomma Lab USA	5244ddee-fd9e-4df3-8fb3-b16aa321a316	2023-12-27	Warnings	Exact identifier application number: M017
Camphor Spirit	CAMPHOR 10%	Pharma Nobis, LLC	e42fbe63-b01c-4f85-e053-2a95a90a5143	2023-12-26	Warnings	Exact identifier application number: M017
Equate Calaspray	PRAMOXINE HCL 1%, ZINC ACETATE 0.1%	Walmart Inc	027ed5ab-05ec-569f-e063-6394a90abbc3	2023-12-26	Warnings	Exact identifier application number: M017
EXTERNAL ANALGESIC	CAMPHOR, CAPSICUM, MENTHOL	Hmong 21	3b6155a5-51aa-2780-e054-00144ff8d46c	2023-12-26	Warnings	Exact identifier application number: M017
LEADER Camphor Spirit	CAMPHOR (NATURAL)	Cardinal Health, 110 dba Leader	7d3b0b28-5190-0622-e053-2991aa0af561	2023-12-22	Warnings	Exact identifier application number: M017
Antiseptic Instant Pain Relief	CAMPHOR 10.8% AND PHENOL 4.7%	Pharma Nobis, LLC	e42f484d-a642-3489-e053-2a95a90a4254	2023-12-22	Warnings	Exact identifier application number: M017
Itch Relief Gel	ITCH RELIEF GEL	Pharma Nobis, LLC	e42f484d-a641-3489-e053-2a95a90a4254	2023-12-22	Warnings	Exact identifier application number: M017
Witch Hazel	WITCH HAZEL	Pharma Nobis, LLC	e42f484d-a644-3489-e053-2a95a90a4254	2023-12-22	Warnings	Exact identifier application number: M017
Dermoplast Pain relieving	BENZOCAINE, MENTHOL	Advantice Health	dad00c95-4e11-3eec-e053-2a95a90a7a18	2023-12-21	Warnings	Exact identifier application number: M017
equate Maximum Strength Pain Relieving 4% Lidocaine with Lavender Essential Oil Topical analgesic	LIDOCAINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	bf954949-a7b7-44ba-8565-f1d5c0a6c0d1	2023-12-21	Warnings	Exact identifier application number: M017
Bactine Max Bandage	LIDOCAINE	WellSpring Pharmaceutical Corporation	465dc46e-6435-4569-9516-f648d0fe0f09	2023-12-21	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