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 67 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QIAN LI ZHUI FENG PAIN RELIEVING	CAMPHOR, MENTHOL, AND METHYL SALICYLATE	MADISON ONE ACME INC	03a4fb7c-2328-409d-99c8-cbcf2b4a451f	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
WU YANG BRAND PAIN RELIEVING MEDICATED	MENTHOL AND CAMPHOR	MADISON ONE ACME INC	05c6b95a-aeb6-4234-97c7-8d77eccb38d8	2025-11-10	Warnings	Exact identifier application number: M017
HEI GUI PAIN RELIEVING	CAMPHOR AND METHYL SALICYLATE	MADISON ONE ACME INC	4140c404-edab-4923-941d-f74125e943a9	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
E MEI SHAN MEDICATED	CAMPHOR AND MENTHOL	MADISON ONE ACME INC	ddcc814e-fcc4-4232-9ab4-826b8aac35f0	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Overtime	METHYL SALICYLATE, MENTHOL AND CAPSAICIN	Physicians Science & Nature Inc.	25fec070-8587-42d1-ba6f-1a9c150acc98	2025-11-10	Warnings	Exact identifier application number: M017
Dendracin Neurodendraxcin	METHYL SALICYLATE, MENTHOL AND CAPSAICIN	Physicians Science & Nature Inc.	05742cd5-ece2-4007-bdf0-46b76d23df74	2025-11-10	Warnings	Exact identifier application number: M017
Anal Blu	DESENSITIZER	Novelties by Nasswalk, Inc.	03b9555b-c3ff-4baa-e063-6394a90afb2c	2025-11-10	Warnings	Exact identifier application number: M017
Stallion	DELAY CREME	Novelties by Nasswalk, Inc.	0261ec88-8fe4-d5f8-e063-6294a90ab3d4	2025-11-10	Warnings	Exact identifier application number: M017
ANAL-ESE	DESENSITIZER	Novelties by Nasswalk, Inc.	03b89eed-b433-a263-e063-6294a90a675b	2025-11-10	Warnings	Exact identifier application number: M017
Instant Erection	ULTIMATE ERECTION ENHANCER	Novelties by Nasswalk, Inc.	03a444f9-7052-0c38-e063-6294a90a4e56	2025-11-10	Warnings	Exact identifier application number: M017
STA-HARD	DESENSITIZING LUBRICANT	Novelties by Nasswalk, Inc.	02ef794b-8e70-5c26-e063-6294a90a28d1	2025-11-10	Warnings	Exact identifier application number: M017
ANAL-ESE	DESENSITIZER	Novelties by Nasswalk, Inc.	03a4a7ce-4cff-a608-e063-6294a90ad65d	2025-11-10	Warnings	Exact identifier application number: M017
FOOTSPA PEDI	ALCOHOL	CHEMCO CORPORATION	04de4392-74f6-7df8-e063-6294a90ae3b1	2025-11-08	Warnings	Exact identifier application number: M017
Johnson and Johnson All Purpose First Aid Kit	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	5cdb47c5-7951-4279-8a05-0a3199d3dd45	2025-11-06	Warnings	Exact identifier application number: M017
Johnson and Johnson First Aid Travel Ready 80 CT	ACETAMINOPHEN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	f388f105-48ba-4616-e053-2a95a90a0049	2025-11-06	Warnings	Exact identifier application number: M017
Johnson and Johnson First Aid All Purpose 160 CT	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	f3933330-2550-4a88-e053-2a95a90a3997	2025-11-06	Warnings	Exact identifier application number: M017
Foot and Leg Pain Relief	LIDOCAINE	Premier Brands of America Inc.	42f23e2f-11c6-da49-e063-6294a90ac720	2025-11-06	Warnings	Exact identifier application number: M017
HEALING TREE CALMING ANTI-ITCH	HYDROCORTISONE	Renu Laboratories, LLC	fc8bcde9-26e8-a35f-e053-6394a90a3300	2025-11-06	Warnings	Exact identifier application number: M017
Calamine Plus	CALAMINE PLUS PRAMOXINE HCL	Chain Drug Marketing Association Inc	1a3f8819-58cf-8923-e063-6394a90a37af	2025-11-06	Warnings	Exact identifier application number: M017
Extra Strength Itch Relief	DIPHENHYDRAMINE HCL AND ZINC ACETATE	Chain Drug Marketing Association Inc	1a2997bc-7741-e658-e063-6394a90af6fd	2025-11-06	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