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 110 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dollar General Cold-Hot Medicated Patches	MENTHOL	DOLGENCORP, LLC	c6e0388b-af9e-4e51-8f94-6788185c31a0	2024-12-18	Warnings	Exact identifier application number: M017
THERA CARE PAIN THERAPY	LIDOCAINE	Veridian Healthcare	e023bb5a-a4bc-4681-a1f4-48ca0d2cb102	2024-12-18	Warnings	Exact identifier application number: M017
TheraCare Medicated Pain Relief Patches	CAMPHOR, MENTHOL, METHYL SALICYLATE	Veridian Healthcare	f6f3c9c0-d6e3-75a3-e053-6294a90a1965	2024-12-18	Warnings	Exact identifier application number: M017
Good Sense Hot and Cold Medicated Patch	MENTHOL	GOOD SENSE	1b16c3e5-a29f-4043-94e6-0a0e0ea3d93e	2024-12-18	Warnings	Exact identifier application number: M017
Hunter Beach 4%	LIDOCAINE	HUNTERS BEACH LIFE	f2ef9c12-6e42-486b-b6f2-0ad534e94294	2024-12-18	Warnings	Exact identifier application number: M017
Hunter Beach 4%	LIDOCAINE	HUNTERS BEACH LIFE	05a9605b-0d01-4333-8e54-7202e7c31c49	2024-12-18	Warnings	Exact identifier application number: M017
Ultra Strength Muscle Rub	CAMPHOR, MENTHOL, METHYL SALICYLATE	The Mentholatum Company	32b64985-0e2f-49ee-9840-946d7279fee7	2024-12-17	Warnings	Exact identifier application number: M017
CVS Health Cold and Hot Pain Relieving Extra Strength	MENTHOL, METHYL SALICYLATE	CVS Pharmacy	1ca1a631-cb2c-46cd-bd41-05469b08d208	2024-12-17	Warnings	Exact identifier application number: M017
Mentholatum Pain Relieving	MENTHOL, METHYL SALICYLATE	The Mentholatum Company	0056b952-9870-485a-9f35-f985472875a9	2024-12-17	Warnings	Exact identifier application number: M017
Mentholatum Lidocaine Heat	LIDOCAINE HCL	The Mentholatum Company	cc2ef25a-b569-4d48-a666-899f710b4b34	2024-12-17	Warnings	Exact identifier application number: M017
Rite Aid Muscle Rub Ultra Strength	CAMPHOR, MENTHOL, METHYL SALICYLATE	Rite Aid Corporation	039fff40-b5ba-42cb-932c-8a70ca92759d	2024-12-17	Warnings	Exact identifier application number: M017
Signature Care Cold and Hot Medicated	MENTHOL	Safeway	88f59f95-0a7c-458c-949c-0dff16ad94e4	2024-12-17	Warnings	Exact identifier application number: M017
Equate Cool and Heat	MENTHOL, METHYL SALICYLATE	Wal-Mart Stores Inc	c5ab2426-eeca-4ba4-9f00-7790d2176471	2024-12-17	Warnings	Exact identifier application number: M017
CVS Health Muscle Rub Ultra Strength	CAMPHOR, MENTHOL, METHYL SALICYLATE	CVS Pharmacy	4fc0d6bb-efa7-40cf-a6d5-e0feaa93c80a	2024-12-17	Warnings	Exact identifier application number: M017
DG Health Maximum Strength Pain Relieving Cleansing	BENZALKONIUM CL, LIDOCAINE HCL	Dollar General Corporation	64f69315-77a3-49dc-940d-efd7a29c6645	2024-12-17	Warnings	Exact identifier application number: M017
Chiggerex	BENZOCAINE	RANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH	5e5d84ab-f57f-448d-a4c1-ced38890eec2	2024-12-17	Warnings	Exact identifier application number: M017
DerMend Moisturizing Anti-Itch	PRAMOXINE HYDROCHLORIDE	Ferndale Laboratories, Inc.	14c7fb1c-a310-4b12-ab2e-7f1c0801995c	2024-12-17	Warnings	Exact identifier application number: M017
Hydrocortisone 1%	HYDROCORTISONE	Geri-Care Pharmaceuticals, Corp	fd67566a-1076-019d-e053-6394a90a415c	2024-12-17	Warnings	Exact identifier application number: M017
Extra Strength	MENTHOL AND METHYL SALICYLATE	NATURES FORMULAE HEALTH PRODUCTS LTD.	d919b50a-5de2-1830-e053-2a95a90ab88d	2024-12-17	Warnings	Exact identifier application number: M017
Cold and Heat Lidocaine Patch Plus Menthol	LIDOCAINE, MENTHOL	Walgreen Company	1f262473-3f3c-4f3f-b507-590d06ff69a9	2024-12-17	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