Home NDC 78181-020 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.
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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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 122 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join anti itch HYDROCORTISONE Meijer, Inc. 2db7bcab-acb8-48ad-8cd1-842ff7765ed9 2024-10-23 Warnings Exact identifier application number: M017 NATUREANCE MIRACLE MENTHOL EROS GLOBAL CORP ec1a2a1f-a38d-9c59-e053-2a95a90ad268 2024-10-23 Warnings Exact identifier application number: M017 Profoot Plantar Relief Strips CAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATE Rooftop Consumer Health, Inc. 65e142d8-da21-4c55-9faf-b387cb6c2c0e 2024-10-23 Warnings Exact identifier application number: M017 Profoot Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE Rooftop Consumer Health, Inc. cc011b79-2761-40f7-8142-88f8e30a179a 2024-10-23 Warnings Exact identifier application number: M017 Profoot Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE Profoot, Inc. 06f82bde-41a1-35f6-e063-6394a90a6437 2024-10-23 Warnings Exact identifier application number: M017 Deep Cover Bug Bite Relief BENZOCAINE Morrisons Outdoors, LLC 25010dd6-fb48-8ee7-e063-6394a90aee6c 2024-10-21 Warnings Exact identifier application number: M017 Evel Knievels Natural Choice Pain Relief MENTHOL, UNSPECIFIED FORM Natural Essentials, Inc. 4576656c-4b6e-6965-7665-6c52756c6573 2024-10-21 Warnings Exact identifier application number: M017 berkley and jensen anti itch HYDROCORTISONE BJWC 5cc6e4f6-c62d-4923-9726-9dbc569a3f49 2024-10-19 Warnings Exact identifier application number: M017 DG Health Hydrocortisone Maximum Strength HYDROCORTISONE Dolgencorp Inc 2cc792b8-dce6-4178-bd6d-63ba268b7747 2024-10-19 Warnings Exact identifier application number: M017 Careland Hydrogel Pain Relief Patches LIDOCAINE, MENTHOL Planet (Anhui) Pharmaceutical Co., Ltd. e970070c-1c3b-49f0-8298-e6c5ebbf50a0 2024-10-18 Warnings Exact identifier application number: M017 Fruit of the Earth Cool Blue Aloe Mist Continuous LIDOCAINE HYDROCHLORIDE Fruit Of The Earth, Inc. d4caae4c-efba-2453-e053-2995a90a5e5f 2024-10-18 Warnings Exact identifier application number: M017 CVS Health Sunburn Relief Cooling Lidocaine 0.5 Pain-Relieving LIDOCAINE HCL CVS Pharmacy f0f1969d-10e0-76ee-e053-2995a90a7336 2024-10-17 Warnings Exact identifier application number: M017 Wong To Yick External Analgesic CAMPHOR MENTHOL METHYL SALICYLATE Wong To Yick Wood Lock Ointment Ltd 16a21af4-6bc0-4ae1-aa3b-1da84c8286e2 2024-10-17 Warnings Exact identifier application number: M017 Wong To Yick External Analgesic CAMPHOR MENTHOL METHYL SALICYLATE Wicsun Trading Inc 0b4bd444-b3c1-47aa-a7e3-f16c92326124 2024-10-17 Warnings Exact identifier application number: M017 Fruit of the Earth Sun Town City Aloe Vera After Sun with Lidocaine HCL LIDOCAINE Fruit of the Earth, Inc. c7a833bd-7457-73a3-e053-2a95a90ac53f 2024-10-17 Warnings Exact identifier application number: M017 Wegmans Aloe After Sun Gel with Lidocaine HCl External Analgesic LIDOCAINE HYDROCHLORIDE WEGMANS FOOD MARKETS INC f70bc438-7ed8-f74d-e053-6394a90a2b3f 2024-10-16 Warnings Exact identifier application number: M017 EQUATE Sunburn relief with Aloe After Sun LIDOCAINE Wal-Mart Stores Inc c25e1288-7ac6-41fc-ab65-26c379f288a7 2024-10-16 Warnings Exact identifier application number: M017 Genuine First Aid Insect Sting Relief Pad 1 ct BENZOCAINE, ALCOHOL GFA Production (Xiamen) Co., Ltd. b119ba37-0ee1-851a-e053-2995a90a85b1 2024-10-15 Warnings Exact identifier application number: M017 PAIN RELIEF PATCHES LIDOCAINE Walgreen Company 1a587e6e-88d1-4b01-abad-9a365dc64a4d 2024-10-15 Warnings Exact identifier application number: M017 TopCare Everyday After Sun Cooling LIDOCAINE HYDROCHLORIDE TOPCO ASSOCIATES LLC baff7293-e1a3-d1f2-e053-2995a90a93ca 2024-10-15 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# 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