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 126 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medicated Herbal Lip Balm	MENTHOL	Earth Mama Angel Baby LLC	1cc2391e-6a7a-609c-e063-6394a90a6305	2024-10-01	Warnings	Exact identifier application number: M017
CVS Health Lidocaine Plus Pain Relieving	LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL	NATURAL ESSENTIALS, INC.	1adb9b74-4a01-4461-b845-f3aedcb3f810	2024-10-01	Warnings	Exact identifier application number: M017
Circata	CAPSAICIN	PureTek Corporation	b67161d7-cc5c-e971-e053-2995a90acbe7	2024-10-01	Warnings	Exact identifier application number: M017
Menticam	CAMPHOR,MENTHOL, METHYL SALICYLATE	PureTek Corporation	ffea2e97-777f-434b-e053-6394a90a3a63	2024-10-01	Warnings	Exact identifier application number: M017
Herb Street Sore Muscle Relief	METHYL SALICYLATE	Balassa Laboratories Inc.	e43943c2-d4cd-44c5-a0ff-403a8d42860f	2024-10-01	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Kroger Company	68dab606-0385-48b7-9a7b-a2cf83d20393	2024-09-29	Warnings	Exact identifier application number: M017
kirkland signature hydrocortisone plus maximum strength	HYDROCORTISONE	Costco Wholesale Company	481341c5-db1f-43fb-aed7-f40495a4eab8	2024-09-29	Warnings	Exact identifier application number: M017
Care One hydrocortisone maximum strength	HYDROCORTISONE	American Sales Company	32593229-d0ac-4d6c-831a-089fc6e76152	2024-09-29	Warnings	Exact identifier application number: M017
good sense anti itch	HYDROCORTISONE	L. Perrigo Company	b7a896cc-1d78-45c0-a73e-aa1e117f7d3b	2024-09-29	Warnings	Exact identifier application number: M017
Topcare Hydrocortisone	HYDROCORTISONE	Topco Associates LLC	b7362f21-f1a3-4edc-b5b6-a16680e05df3	2024-09-29	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	H E B	412ca2d1-064b-4438-aee1-fcb5cf27c7db	2024-09-29	Warnings	Exact identifier application number: M017
Topcare Antibiotic	NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	Topco Associates LLC	8c349cac-20e1-4600-9b0a-fcfe929551c5	2024-09-26	Warnings	Exact identifier application number: M017
good sense anti itch	HYDROCORTISONE	A-S Medication Solutions	072dd455-24a5-4a44-aaef-d3e137d005a6	2024-09-26	Warnings	Exact identifier application number: M017
SYREN Intimate Relief	LIDOCAINE HYDROCHLORIDE	Icon Health Science	57d5a080-3583-4510-e053-2a91aa0ad589	2024-09-25	Warnings	Exact identifier application number: M017
AOSI HEALTHCARE	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	f4db90ad-dd62-44f1-9655-2614ed36581e	2024-09-25	Warnings	Exact identifier application number: M017
AOSI HEALTHCARE BURN	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	a28b920c-0bb8-4b5a-addd-26ea164e036e	2024-09-25	Warnings	Exact identifier application number: M017
anti itch	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Kroger Company	067e718a-ec0b-4895-8f9f-82d64ab4c7b4	2024-09-24	Warnings	Exact identifier application number: M017
topcare anti itch	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Topco Associates LLC	e0fb332a-2903-41ef-b35b-7cd3a74cff99	2024-09-24	Warnings	Exact identifier application number: M017
equaline anti itch	HYDROCORTISONE	United Natural Foods, Inc. dba UNFI	83cd9f60-a4c4-4dea-97a7-cd96aade9e88	2024-09-24	Warnings	Exact identifier application number: M017
good sense itch relief	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	L. Perrigo Company	162fe0a3-3995-4e6f-94ed-f839b2b0c80e	2024-09-24	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