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 85 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Veneno de Abeja Aceite De Vibora Brand	METHYL SALICYLATE	Menper Distributors Inc.	ad940dc8-9403-44cf-aed3-6e538cbe488b	2025-07-22	Warnings	Exact identifier application number: M017
Balsamo de Vaca Mascura	METHYL SALICYLATE	Menper Distributors Inc.	321b6f1f-c802-4b96-99d3-e77217da11a3	2025-07-22	Warnings	Exact identifier application number: M017
Abejas y Viboras Roll On	METHYL SALICYLATE	Menper Distributors Inc.	bedf3b36-7def-099f-e053-2a95a90ac15b	2025-07-22	Warnings	Exact identifier application number: M017
HealthWise Flexible 4% Lidocaine Patch	LIDOCAINE 4%	Veridian Healthcare	3869cc18-5494-6142-e063-6394a90a75e5	2025-07-22	Warnings	Exact identifier application number: M017
Arthcal 4% Lidocaine Patches	LIDOCAINE	Beijing JUNGE Technology Co., Ltd.	2e531194-67ad-c645-e063-6394a90a916c	2025-07-22	Warnings	Exact identifier application number: M017
AMRUTANJAN RELIEF STRONG PAIN BALM	MENTHOL, METHYL SALICYLATE	AMRUTANJAN HEALTH CARE LIMITED	206d8c1e-eb5b-4ec7-a54e-8defc9fb9d27	2025-07-22	Warnings	Exact identifier application number: M017
Cold Sore Fast-Acting Pain Relief	GLYCERIN AND LIDOCAINE	Blistex Inc.	c7511322-dd6c-441c-bf7d-ad4f0c14956a	2025-07-22	Warnings	Exact identifier application number: M017
Mountain Ice Sports Pain Relief	MENTHOL, CAMPHOR	Mountainside Medical Equipment, Inc.	c1f5512c-67b1-4ff0-b1a5-616e883d436f	2025-07-21	Warnings	Exact identifier application number: M017
Stopain Clinical Roll-On	MENTHOL, UNSPECIFIED FORM	Troy Manufacturing, Inc.	27703209-fdac-4620-a445-d89a84bc853d	2025-07-21	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	STRATEGIC SOURCING SERVICES LLC	9bac1869-8072-49bd-8568-a87a184d2200	2025-07-21	Warnings	Exact identifier application number: M017
Dr Kevin Khalili Pain Relief Cream	MENTHOL	DR. KHALILI LLC	3a79b38c-9adc-60dd-e063-6394a90a5b30	2025-07-21	Warnings	Exact identifier application number: M017
ARTHRITIS PAIN RELIEF	CAMPHOR, CAPSAICIN, METHYL SALICYLATE	YUNNAN BAIYAO GROUP CO., LTD.	671c57f0-3c6f-4416-bc81-f6930fef327b	2025-07-21	Warnings	Exact identifier application number: M017
GoodSense Cooling Pain Relief	MENTHOL	Geiss, Destin & Dunn, Inc	2e5e1375-df07-9a43-e063-6394a90a9938	2025-07-20	Warnings	Exact identifier application number: M017
Benadryl Extra Strength Itch Cooling	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Kenvue Brands LLC	a7eae5dc-9db6-4bdf-9179-76060e75e044	2025-07-18	Warnings	Exact identifier application number: M017
Nicotine Patches	NICOTINE PATCHES	Shenzhen TeLaFaErJiaLuo Technology Co., Ltd.	3a1abd26-c0aa-8a65-e063-6294a90ab66e	2025-07-17	Warnings	Exact identifier application number: M017
Aouiv 4% Lidocaine Numbing Cream	4% LIDOCAINE NUMBING CREAM	Guangzhou Qiexiran Cosmetics Co., Ltd.	3a221dd2-e945-bd0e-e063-6294a90a8fb9	2025-07-17	Warnings	Exact identifier application number: M017
Alocane Plus	LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE	Quest Products, Inc.	24538037-1d74-48a0-b909-98ecc57651fe	2025-07-17	Warnings	Exact identifier application number: M017
Hydrocortisone anti-itch plus	HYDROCORTISONE	Wal-Mart Stores, Inc.	a0c6e180-b385-4a9b-a9cf-84a551f533d0	2025-07-16	Warnings	Exact identifier application number: M017
OTC Rescue Lidocaine Pain Relief Patch	LIDOCAINE	Veridian Healthcare	0e742fc6-5f76-d202-e063-6394a90acf31	2025-07-16	Warnings	Exact identifier application number: M017
Itch Relief	HYDROCORTISONE	STRATEGIC SOURCING SERVICES LLC	ae4b7cd6-8b5d-4d25-86f9-72260638bb94	2025-07-16	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