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 112 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QC Cool and Heat Roll-On	MENTHOL 16%	Chain Drug Marketing Association Inc	d35e9dfa-8a28-fdb3-e053-2995a90abc52	2024-12-15	Warnings	Exact identifier application number: M017
Meijer Cold and Hot Pain Relieving	MENTHOL 16%	Meijer	bec62df3-06c9-a115-e053-2995a90a4267	2024-12-15	Warnings	Exact identifier application number: M017
Tommie Copper Pain Relief	MENTHOL 16%	Tommie Copper, Inc.	b4dfa5fa-2d61-db1e-e053-2a95a90a7ac8	2024-12-15	Warnings	Exact identifier application number: M017
Pain Relief Liquid Roller	CAMPHOR 3.5%, MENTHOL 3.5%	Tommie Copper, Inc.	c9f0447e-de43-16a5-e053-2995a90a05c1	2024-12-15	Warnings	Exact identifier application number: M017
Tommie Copper Pain Relief Maximum Strength	TROLAMINE SALICYLATE 10%	Tommie Copper, Inc.	b622c14f-9bf3-0bbd-e053-2a95a90a2adc	2024-12-15	Warnings	Exact identifier application number: M017
Copperlife Pain Relief	TROLAMINE SALICYLATE 10%	Tommie Copper, Inc.	c94d00f9-42ce-1d43-e053-2a95a90a058d	2024-12-15	Warnings	Exact identifier application number: M017
Tommie Copper Pain Relief Roller	CAMPHOR 3.5%, MENTHOL 3.5%	Tommie Copper, Inc.	b6c3d6eb-b485-33b8-e053-2a95a90a41e1	2024-12-15	Warnings	Exact identifier application number: M017
Tommie Copper Pain Relief Roller	CAMPHOR 3.5%, MENTHOL 3.5%	Tommie Copper, Inc.	b4cd4fed-e8c8-db85-e053-2995a90a708b	2024-12-15	Warnings	Exact identifier application number: M017
Copperlife Pain Relief Liquid	MENTHOL 16%	Tommie Copper, Inc.	c93a0139-953b-5523-e053-2a95a90a0b2d	2024-12-15	Warnings	Exact identifier application number: M017
Tommie Copper Pain Relief	TROLAMINE SALICYLATE 10%	Tommie Copper, Inc.	ca011b03-a263-1908-e053-2995a90ad970	2024-12-15	Warnings	Exact identifier application number: M017
Warrior Chiggerex Relief	BENZOCAINE 10%	Derma Care Research Labs, LLC	dcf2f52b-2295-58e5-e053-2995a90a7fd8	2024-12-15	Warnings	Exact identifier application number: M017
Capsaicin Cream	CAPSAICIN	Trifecta Pharmaceuticals USA LLC	def8d341-06a7-0e9b-e053-2995a90a0ad6	2024-12-13	Warnings	Exact identifier application number: M017
Mentholatum Original	CAMPHOR, MENTHOL	The Mentholatum Company	19e4b812-67c6-49fd-833a-b432100363f5	2024-12-13	Warnings	Exact identifier application number: M017
Cold and Hot Medicated	MENTHOL	The Mentholatum Company	85bf425d-59d7-4462-ba46-292145460099	2024-12-13	Warnings	Exact identifier application number: M017
Mentholatum Lidocaine Ice	LIDOCAINE HCL, MENTHOL	The Mentholatum Company	4d74cbab-31cd-4579-9360-6852ee215b5e	2024-12-13	Warnings	Exact identifier application number: M017
Mentholatum Deep Heating Rub Extra Strength	MENTHOL, METHYL SALICYLATE	The Mentholatum Company	f5684158-0d83-4031-b493-5422ddc73e78	2024-12-13	Warnings	Exact identifier application number: M017
Discount Drug Mart Anti-Itch	CAMPHOR, MENTHOL	Discount Drug Mart	87d379da-103a-c751-e053-2995a90a56de	2024-12-13	Warnings	Exact identifier application number: M017
Audiologist Anti-itch	HYDROCORTISONE	OAKTREE PRODUCTS, INC.	853e078e-1e91-d55f-e053-2991aa0a6dcd	2024-12-13	Warnings	Exact identifier application number: M017
CVS Anti itch	HYDROCORTISONE	CVS	884df604-711b-4a3d-e053-2995a90a3a04	2024-12-13	Warnings	Exact identifier application number: M017
Dermoplast Pain Relieving	BENZOCAINE AND LEVOMENTHOL	Advantice Health, LLC	2347f0b8-d463-422d-8583-65624d9a1a91	2024-12-12	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