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 90 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Re-Lieved Lidocaine Patch	LIDOCAINE PATCH 4%	Transfer Technology	37ef02d4-2ff5-cb23-e063-6294a90a68af	2025-06-19	Warnings	Exact identifier application number: M017
Post-Treatment Repair Cream	HYDROCORTISONE	Vi Medical Products Inc.	ab8885a9-0778-28ff-e053-2995a90a2e12	2025-06-19	Warnings	Exact identifier application number: M017
MyDerm	LIDOCAINE	Inspec Solutions LLC.	82d075d1-c92e-2097-e053-2991aa0ab131	2025-06-18	Warnings	Exact identifier application number: M017
Walgreens Extra Small Lidocaine	LIDOCAINE	Walgreen Co.	dc838e47-d234-4ba5-9449-f645e99be923	2025-06-18	Warnings	Exact identifier application number: M017
CLn Body Moisturizer	COLLOIDAL OAT MOISTURIZER	TopMD Skin Care, Inc.	2de3d68d-a540-d456-e063-6394a90a4b57	2025-06-18	Warnings	Exact identifier application number: M017
Aloe UP SPF 30 Mineral	ZINC OXIDE, TITANIUM DIOXIDE	Aloe Care International, LLC	35967b33-bdfb-ee3c-e063-6294a90a75f6	2025-06-18	Warnings	Exact identifier application number: M017
Aloe Up SPF 50 Mineral	ZINC OXIDE, TITANIUM DIOXIDE	Aloe Care International, LLC	35b9dcfa-05f3-3d7b-e063-6394a90a18f1	2025-06-18	Warnings	Exact identifier application number: M017
Aloe Up SPF 50 Mineral	ZINC OXIDE	Aloe International, LLC	35bc3621-f4e4-42d3-e063-6394a90a7aad	2025-06-18	Warnings	Exact identifier application number: M017
Aloe Up SPF 50 Kids Mineral	ZINC OXIDE, TITANIUM DIOXIDE	Aloe Care International, LLC	35cd16b0-bd81-8f68-e063-6294a90a3d8c	2025-06-18	Warnings	Exact identifier application number: M017
Aloe Up SPF 50 Kids Mineral	ZINC OXIDE	Aloe International, LLC	35cd5542-947d-a042-e063-6394a90a13f8	2025-06-18	Warnings	Exact identifier application number: M017
Relieve Your Pain	MENTHOL	Proximity Capital Partners LLC dba Asutra	c12369dd-8305-edaf-e053-2995a90a0d3d	2025-06-18	Warnings	Exact identifier application number: M017
Melt Pain Away	CAPSAICIN	Proximity Capital Partners LLC dba Asutra	a95a11d7-a2ae-6654-e053-2a95a90a802c	2025-06-18	Warnings	Exact identifier application number: M017
Recovery Roll-On	MENTHOL, CAMPHOR	PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA	ebc9630f-6d8b-e4f0-e053-2995a90a0b49	2025-06-18	Warnings	Exact identifier application number: M017
ProCure Hydrocortisone 1%	HYDROCORTISONE	Twin Med LLC	37cdfabc-1fdb-246a-e063-6394a90a008a	2025-06-17	Warnings	Exact identifier application number: M017
ProCure Hydrocortisone 1%	HYDROCORTISONE	Twin Med LLC	37ce6c35-b211-43de-e063-6294a90ab773	2025-06-17	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE CREAM 1%	Sun Pharmaceutical Industries, Inc.	312ddc8d-100e-cfac-e063-6294a90acd09	2025-06-16	Warnings	Exact identifier application number: M017
Curist 5% Lidocaine	LIDOCAINE 5%	Little Pharma, Inc.	f20241a2-c5b1-f124-e053-2995a90a891b	2025-06-16	Warnings	Exact identifier application number: M017
Toast Screamin Menthol	MENTHOL	IDEAZ, LLC	37b48b1a-ef3d-afdc-e063-6294a90a6610	2025-06-16	Warnings	Exact identifier application number: M017
Toast Freezin Cold	MENTHOL, METHYL SALICYLATE	IDEAZ, LLC	37b4d363-0099-8cd3-e063-6394a90a18d6	2025-06-16	Warnings	Exact identifier application number: M017
Earths Care Anti-Itch	CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM	DLC Laboratories, Inc.	ba65f58a-d590-498a-b8e7-a3d78935d880	2025-06-13	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