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 45 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DZUL - LIDO CREME	LIDOCAINE HCL, MENTHOL	Caball Sales, Inc.	063387e4-a1b1-a467-e063-6294a90a6cbd	2026-01-08	Warnings	Exact identifier application number: M017
TOPICAINE	LIDOCAINE 4%	ESBA LABORATORIES INC.	7f96e980-891e-743d-e053-2a91aa0aea5f	2026-01-08	Warnings	Exact identifier application number: M017
LUBRICAINE	LIDOCAINE 4%	ESBA LABORATORIES INC.	9d7416b1-607d-34e0-e053-2a95a90aa3c3	2026-01-08	Warnings	Exact identifier application number: M017
0.5% LIDOCAINE BURN RELIEF	LIDOCAINE HYDROCHLORIDE	Universal Distribution Center LLC	0a1aeff0-bade-457b-a0ac-099d646c0b2e	2026-01-08	Warnings	Exact identifier application number: M017
4% MENTHOL COLD THERAPY	MENTHOL	Universal Distribution Center LLC	66892993-a755-4584-b2a8-2e8d7ac70593	2026-01-08	Warnings	Exact identifier application number: M017
Private Label Antifungal Barrier Cream	2% MICONAZOLE NITRATE CREAM	Swiss-American CDMO, LLC	e74bddea-c1ac-4e4e-84bd-5a9defb85b2d	2026-01-08	Warnings	Exact identifier application number: M017
2.0% LIDOCAINE BURN	LIDOCAINE HYDROCHLORIDE	Universal Distribution Center LLC	e1911279-85f7-4053-b6da-8f4e991347a2	2026-01-08	Warnings	Exact identifier application number: M017
POMG PAIN RELIEF ROLLER	LIDOCAINE HYDROCHLORIDE, MENTHOL	POMG LLC	1fa980fb-fc0e-fdd0-e063-6394a90adc13	2026-01-07	Warnings	Exact identifier application number: M017
Artridon Glucosamine	MENTHOL, METHYL SALICYLATE	Pharmadel LLC	73572156-4cce-0669-e053-2991aa0aaecc	2026-01-07	Warnings	Exact identifier application number: M017
HealthWise Cooling Pain Relief	MENTHOL	Veridian Healthcare	6e2ad0ab-e3a8-4e3a-8f1d-2cd6351185bd	2026-01-07	Warnings	Exact identifier application number: M017
Hydrocortisone 1% Anti-Itch Cream	HYDROCORTISONE	DLC Laboratories, Inc.	16eeec2c-065d-4da0-e063-6294a90a3873	2026-01-07	Warnings	Exact identifier application number: M017
Maximum Strength Hydrocortisone	HYDROCORTISONE	DLC Laboratories, Inc	caf50f12-f35c-4e9e-8ef7-3b0c84e225ee	2026-01-07	Warnings	Exact identifier application number: M017
EARTHS CARE MUSCLE AND JOINT RUB	CAMPHOR	DLC Laboratories, Inc.	71e33e06-4dc3-4ead-a122-ff89d93a64de	2026-01-07	Warnings	Exact identifier application number: M017
Amour CBD	PAIN RELIEF CREAM	SVD Premium Products	95b45e79-b1e7-17b2-e053-2995a90a8836	2026-01-07	Warnings	Exact identifier application number: M017
Tiger Balm Active Muscle	METHYL SALICYLATE AND MENTHOL, UNSPECIFIED FORM	Haw Par Healthcare Ltd.	845a4ead-f9c0-4009-bcae-b17cd388439b	2026-01-07	Warnings	Exact identifier application number: M017
3X Medicated Toothache and Gum Gel	BENZOCAINE	Rite Aid	996f7989-17ce-5b28-e053-2995a90af8b8	2026-01-06	Warnings	Exact identifier application number: M017
QNTAMAX Muscle and Joint Pain Relieving	CAMPHOR (SYNTHETIC), MENTHOL	Qntamax LLC	6622b94c-824e-4e84-a8d8-b60bb0b866e2	2026-01-06	Warnings	Exact identifier application number: M017
Winco Muscle and Joint Pain Relief Gel 2oz	WINCO BENGAY VANISHING SCENT MUSCLE AND JOINT PAIN RELIEF	WINCO FOODS, LLC	47bedf4e-4036-cf43-e063-6394a90a91d6	2026-01-06	Warnings	Exact identifier application number: M017
Pain Relief Hot Patch	MENTHOL AND CAPSAICIN	Universal Distribution Center LLC	110bcb16-ef0b-4bc8-8877-173a0494e1ad	2026-01-06	Warnings	Exact identifier application number: M017
WOFANLI Quit Smoking Nicotine Patches	NICOTINE PATCHES	Shenzhen Paxi Trading Co., Ltd.	4582b4e9-0c24-069d-e063-6394a90a6f4b	2026-01-05	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