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 21 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
New Terocin	METHYL SALICYLATE, CAPSAICIN, AND MENTHOL	ASCLEMED USA INC.	68dc0231-3364-448b-bde9-f19fa122c765	2026-05-05	Warnings	Exact identifier application number: M017
Lidocaine 4% Patch	LIDOCAINE 4%	SOLA Pharmaceuticals	c31957dd-edea-ce98-e053-2a95a90a9c2d	2026-05-05	Warnings	Exact identifier application number: M017
Biofreeze Triple Target Gel	CAMPHOR, CAPSAICIN, MENTHOL	Reckitt Benckiser LLC	511852c8-7428-3234-e063-6394a90a5bc2	2026-05-05	Warnings	Exact identifier application number: M017
5Kind DMSO Pain Relieving	CAMPHOR (SYNTHETIC)	5Kind Trading LTD	62b55114-47f4-473a-8406-78238c3c1fa2	2026-05-04	Warnings	Exact identifier application number: M017
Zinc Oxide with Menthol and White Petrolatum	MENTHOL, ZINC OXIDE, WHITE PETROLATUM	Aldermed Inc.	f993fc0a-bd80-4345-a948-65ac03f910e2	2026-05-04	Warnings	Exact identifier application number: M017
EVERLIT CARE PRODUCTS BURN RELIEF	LIDOCAINE HYDROCHLORIDE	EVERLIT GLOBAL INC.	d7ec5720-4d1f-4943-ae36-c7d6acbae7d7	2026-05-04	Warnings	Exact identifier application number: M017
EVERLIT CARE PRODUCTS BURN RELIEF	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	5371dae4-ea63-46cc-ac26-5418f359c63e	2026-05-04	Warnings	Exact identifier application number: M017
EVERLIT CARE BURN	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	a2cf1726-3dc9-4624-b898-ac91fb4cbdb2	2026-05-04	Warnings	Exact identifier application number: M017
FIRSTAR BURN	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	186343c5-2e71-49c4-8d64-5fb3131239fa	2026-05-04	Warnings	Exact identifier application number: M017
Feminine Anti Itch Cream	BENZOCAINE,RESORCINOL	TRIFECTA PHARMACEUTICALS USA LLC	50c3acbf-b873-908a-e063-6294a90a66b7	2026-05-01	Warnings	Exact identifier application number: M017
24 7 Relief and Recovery Pain Relieving	MENTHOL, UNSPECIFIED FORM	Triplicare Inc	53ca807b-3ec2-4b5e-aa5a-6dcb756bb423	2026-04-30	Warnings	Exact identifier application number: M017
FIRST AID BURN	LIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE	4 Visions LLC	50b1351d-72dd-e0c9-e063-6294a90ac743	2026-04-30	Warnings	Exact identifier application number: M017
TheraCare Flexible Pain Relieving	LIDOCAINE	Veridian Healthcare	4f108002-2cae-0671-e063-6294a90ab6cf	2026-04-30	Warnings	Exact identifier application number: M017
Pain Relief Gel Roll On	MENTHOL	Trifecta Pharmaceuticals USA	50b1a420-d5cd-6d61-e063-6294a90a0451	2026-04-30	Warnings	Exact identifier application number: M017
Dr. Numb	LIDOCAINE AND BENZETHONIUM CHLORIDE CREAM	Shinpharma Inc	d8cdccdb-775b-4970-a6ea-50b62df221d6	2026-04-30	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Padagis Israel Pharmaceuticals Ltd	2dc7f76f-f9ad-46ba-8b41-952e1c15f052	2026-04-29	Warnings	Exact identifier application number: M017
anti itch	HYDROCORTISONE	HyVee Inc	e1db3641-2e83-4fec-8394-98d0d876ce0d	2026-04-29	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On	MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	50805eee-33b3-86bd-e063-6294a90a77d8	2026-04-28	Warnings	Exact identifier application number: M017
FixMySkin Healing Balm Vanilla Flavor	HYDROCORTISONE	Lovely Skin, Inc.	52f7a561-a0b5-4562-a588-d74fd874b83a	2026-04-28	Warnings	Exact identifier application number: M017
Blue Star Medicated	CAMPHOR	Focus Consumer Healthcare, LLC	56df008e-a23b-4870-e054-00144ff8d46c	2026-04-27	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