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 66 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYDROCORTISONE	HYDROCORTISONE	Encube Ethicals, Inc.	969cd576-82d3-4662-bbc1-3587a1f6a564	2025-11-10	Warnings	Exact identifier application number: M017
Jelcaine Sterile	LIDOCAINE HCL JELLY USP, 2%	Brookfield Pharmaceuticals, LLC	1a39d1de-7aa2-3068-e063-6394a90aed85	2025-11-10	Warnings	Exact identifier application number: M017
Hush Anesthetic	LIDOCAINE	HUSH Anesthetic	c6e86a0f-6f9b-45b7-86ce-0bb1c198061a	2025-11-10	Warnings	Exact identifier application number: M017
Hush Anesthetic	LIDOCAINE	HUSH Anesthetic	97ae1993-7268-4b7f-92e2-6004337d5650	2025-11-10	Warnings	Exact identifier application number: M017
MENTHOL AND METHYL SALICYLATE	ELECTRIC MEDICATED BALM ULTRA STRENGTH	FEI FAH MEDICAL MANUFACTURING PTE LTD	91e6d3b9-25bb-4015-9d96-bd27f93e5ada	2025-11-10	Warnings	Exact identifier application number: M017
E MEI SHAN MEDICATED	CAMPHOR, MENTHOL	Zhejiang Dingtai Pharmaceutical Co., Ltd	bda1e7c1-42df-4126-a512-80f843b07fd0	2025-11-10	Warnings	Exact identifier application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEVING	CAMPHOR AND MENTHOL	Zhejiang Dingtai Pharmaceutical Co., Ltd	9850754b-ac94-4ec6-b75a-8096e5ac9456	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
TONG FENG DING PAIN RELIEF	CAMPHOR AND MENTHOL	Zhejiang Dingtai Pharmaceutical Co., Ltd	fe87b864-b3ee-4a4b-8e5a-e1ee6493de0d	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Solstice Pain Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	5ef90782-8201-47d1-b57f-f032d4c9b06a	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Solstice Pain Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	1388ab3a-c26f-427d-898d-0d88411a5fba	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Solstice Capsaicin Patch Hot	CAPSAICIN	MADISON ONE ACME INC	f74db6e0-853a-4eb3-a4b5-9da2cd3d95cf	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Lung Choy Shung Pain Relief Liquid	MENTHOL AND CAMPHOR	MADISON ONE ACME INC	4842c6ec-7823-4f6b-afc4-258fce2c2391	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
701 DIEDA ZHENGTONG YAOGAO MEDICATED	CAMPHOR AND MENTHOL	MADISON ONE ACME INC	115041ff-5046-4ca4-b54b-5652037e74bd	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEF	CAMPHOR AND MENTHOL	MADISON ONE ACME INC	0f269a41-4b56-4e22-b9cb-17d99bf76a57	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
ZANG HONG HUA PAIN RELIEVING	CAMPHOR, CAPSAICIN, AND METHYL SALICYLATE	MADISON ONE ACME INC	e0a8811c-07cf-4dee-a0e5-13b8af1b27b6	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
NECK AND LUMBAR PAIN RELIEVING BALM	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	d06f0650-a5f6-4bc1-a70b-b0fc16968fa9	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
SHU JIN HUO LUO PAIN RELIEVING	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	ccb6740d-3399-4a2b-ae65-15ca557ba83b	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
GuruNanda Pain Relief	LIDOCAINE HYDROCHLORIDE	GuruNanda, LLC.	3ab6a133-8dca-e14e-e063-6394a90a85e7	2025-11-10	Warnings	Exact identifier application number: M017
HUO LUO PAIN RELIEVING	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	65581716-5a2c-4ee8-816d-00caed7b95b4	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
JOSEPHS LION PAIN RELIEVING	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	69b88e21-2001-4fb2-b6eb-17f2d6e0ef2e	2025-11-10	Warnings, Adverse reactions	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