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 16 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mineral Ice Extreme Dry Stick	MENTHOL	Carlin Consumer Health LLC	4f81be91-92e5-1205-e063-6394a90a6e82	2026-06-02	Warnings	Exact identifier application number: M017
Kalaya Extra Strength Pain Relief Gel with Arnica	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	b6a6237d-b471-4102-b5df-fc389f5f9258	2026-06-02	Warnings	Exact identifier application number: M017
Biofreeze Ultraflex	LIDOCAINE	Reckitt Benckiser LLC	2655974b-a67d-9f07-e063-6294a90a54e8	2026-06-02	Warnings	Exact identifier application number: M017
Biofreeze Ultraflex Plus	LIDOCAINE, MENTHOL	Reckitt Benckiser LLC	401e1843-e9a6-fda9-e063-6294a90a3073	2026-06-02	Warnings	Exact identifier application number: M017
Pain Relief	MENTHOL SPRAY	Owell Naturals Brand, LLC	534c871c-da35-6135-e063-6294a90aa9f6	2026-06-02	Warnings	Exact identifier application number: M017
Charm Tex FLUORIDE Gel	SODIUM FLUORIDE	Jiangsu Gold Worldworks Household Chemicals Co., Ltd.	09d47bd7-1438-4ef2-85e0-9cd5eb2f763a	2026-05-31	Warnings	Exact identifier application number: M017
Charm Tex FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Jiangsu Gold Worldworks Household Chemicals Co., Ltd.	2bddc69a-0c0f-47fc-bc98-90c2ec70dd6f	2026-05-31	Warnings	Exact identifier application number: M017
Sting Relief Prep Pad	BENZOCAINE	NINGBO TIANBO FIRST AID PRODUCT CO., LTD.	9487d15d-9116-4ff8-a004-ba0835ea091e	2026-05-31	Warnings	Exact identifier application number: M017
Careland Kinesiology Pain Relieving Tape	CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE	Planet (Anhui) Pharmaceutical Co., Ltd.	35d24cfc-9d34-4fd7-9312-1673b092a3b9	2026-05-31	Warnings	Exact identifier application number: M017
Walgreens Scalp Itch Relief	HYDROCORTISONE	Walgreens	34952272-1f9e-c642-e063-6394a90ae2bd	2026-05-29	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine No-Mess Applicator	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	8092cde7-28d0-4755-b5c0-5765934e572f	2026-05-29	Warnings	Exact identifier application number: M017
Belladona and Arnica	MENTHOL	Dannso Corp./d.b.a. Essential Products	fc4e63e4-cebc-49ff-8900-7238261d0fe0	2026-05-28	Warnings	Exact identifier application number: M017
Insect Sting Relief	BENZOCAINE, ALCOHOL	Hubei Fanjian Medical Product Co.,Ltd	f30401c1-961e-44dd-e053-2a95a90a69d6	2026-05-28	Warnings	Exact identifier application number: M017
Menthol plus Camphor Pain Relief	MENTHOL, CAMPHOR	Veridian Healthcare	4a054949-0889-7182-e063-6394a90aff5e	2026-05-28	Warnings	Exact identifier application number: M017
Antibacterial Lidocaine Wound Gel	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	CVS Pharmacy	960bfe55-87f6-3e51-e053-2995a90a867d	2026-05-27	Warnings	Exact identifier application number: M017
MyDerm Medical 5 Lidocaine Numbing Roll-On	LIDOCAINE	Inspec Solutions	1d466be1-a780-462f-8dd4-87478da096aa	2026-05-27	Warnings	Exact identifier application number: M017
myDerm Cooling Menthol Pain Relief with 50 Percent More Menthol	MENTHOL	Inspec Solutions LLC.	d427d623-c2fd-7d6b-e053-2995a90abdc3	2026-05-27	Warnings	Exact identifier application number: M017
Caldyphen Clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Amerisource Bergen	d8802e56-649e-4494-86ee-7ca8841cc28b	2026-05-27	Warnings	Exact identifier application number: M017
Equate Itch Relief Gel	ITCH RELIEF GEL	Walmart, Inc	7d7bb750-017e-c60e-e053-2991aa0ad671	2026-05-26	Warnings	Exact identifier application number: M017
MyDerm Bite and Sting	BENZOCAINE	Medline Industries	bf45c4dd-5814-4602-b96b-f82a44948763	2026-05-26	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