FDA.reportPublic FDA data

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage78181-020-18ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage78181-020-07ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage78181-020-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage78181-020-28ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage78181-020-18367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage78181-020-07367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage78181-020-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage78181-020-28367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage78181-020-18557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage78181-020-07557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage78181-020-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage78181-020-28557ba5c1ecfa…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
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1020365Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
16650277-fa62-485e-9a82-7763d2b50168Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78181-020-02GENTLECARE HAND AND SKIN SANITIZER50 mL in 1 BOTTLE, PUMPLIQUID508
78181-020-07GENTLECARE HAND AND SKIN SANITIZER221 mL in 1 BOTTLE, PUMPLIQUID2218
78181-020-18GENTLECARE HAND AND SKIN SANITIZER550 mL in 1 BOTTLE, PUMPLIQUID5508
78181-020-28GENTLECARE HAND AND SKIN SANITIZER3785 mL in 1 JUGLIQUID37858

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78181-020GENTLECARE HAND AND SKIN SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [PARAGON SOLUTIONS US, INC.]7Current NDC, Legacy NDC, 4 package rows20241215_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 52 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Large Medicate Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEAmerisource Bergena7d5f89b-59b9-4603-99aa-273b85be813e2025-12-22WarningsExact identifier
application number: M017
Good Neighbor Capsaicin Heat Patch for BackCAPSAICINAmerisource Bergenf873a0b8-8123-1600-e053-6394a90a043e2025-12-22WarningsExact identifier
application number: M017
Good Neighbor Pharmacy Cold Therapy Pain Relief PatchMENTHOLAmerisource Bergenf872f371-b92c-f5d5-e053-6294a90a7dcd2025-12-22WarningsExact identifier
application number: M017
Caring Mills HydrocortisoneHYDROCORTISONEVeridian Healthcareb0b1889b-3099-4943-a4cb-d9a898a068602025-12-22WarningsExact identifier
application number: M017
LIDOCAINE 5%LIDOCAINEMedhome Pharma Inc46968f5a-d214-9871-e063-6394a90ab45d2025-12-22WarningsExact identifier
application number: M017
Blue-Emu THRIVE CoolingTRIPELENNAMINE 0.5%Kingsway Pharmaceuticals dba NFI, LLC7ac6456a-42c5-4ac8-aae6-db4abfda9df02025-12-22WarningsExact identifier
application number: M017
MENTHOLMENTHOLSUNSET PAIN RELIEF45c5ca6f-d425-6cfb-e063-6394a90a1b662025-12-20WarningsExact identifier
application number: M017
HERSTAT GST Genital Sore TreatmentCAMPHOR, MENTHOLHerstat (USA) Inc.e8d27684-fb15-2e6a-e053-2a95a90a248f2025-12-19WarningsExact identifier
application number: M017
Kroger Anti ItchHYDROCORTISONEThe Kroger Co46547277-f11a-b9e7-e063-6294a90a2ccd2025-12-19WarningsExact identifier
application number: M017
Kroger Cool and Heat Roll-OnMENTHOLKroger46551d07-3006-c3ec-e063-6294a90aa3f22025-12-19WarningsExact identifier
application number: M017
Naughty Kitty KatNO GAG DEEP THROAT SPRAYINKED SUGAR, INC170eb644-c72c-5744-e063-6394a90a767d2025-12-19WarningsExact identifier
application number: M017
Tiger Balm Red Extra StrengthCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.ce703715-4c11-472c-9270-daac87b7be052025-12-19WarningsExact identifier
application number: M017
Aspercreme with Lidocaine Foot Pain CremeLIDOCAINE HYDROCHLORIDEChattem, Inc.da82cc0e-cc39-408e-87e1-c35bb6f9f51e2025-12-19WarningsExact identifier
application number: M017
Health Trak Plus Menthol-Infused Pain Relief SocksMENTHOLRailroad Sock LLC43413e55-1db2-fc1a-e063-6394a90a71672025-12-18WarningsExact identifier
application number: M017
BIO-ICEMENTHOL, CAMPHORElectrostim Medical Services Inc. d/b/a EMSI1bfd1468-9139-43b1-9709-d47b63d17cfb2025-12-18WarningsExact identifier
application number: M017
LidotrodeLIDOCAINEStrand Health Group1fd20b9a-b8bc-c94f-e063-6394a90a2b692025-12-18WarningsExact identifier
application number: M017
A Health Itch Relief GelITCH RELIEF GELBionpharma, Inc.ecf5decb-c98b-7739-e053-2995a90a55412025-12-18WarningsExact identifier
application number: M017
After Burn2.5% LIDOCAINE HCLTender Corporation d/b/a Adventure Ready Brands4640395f-a76c-d022-e063-6294a90adde62025-12-18WarningsExact identifier
application number: M017
SPARTAN WIPESENDURANCE WIPESTIV PRIME SRL26d02431-2c95-001c-e063-6394a90a29c72025-12-18WarningsExact identifier
application number: M017
Stopain Extra Strength ContinuousMENTHOLTroy Manufacturing, Inc.a0f76968-d22c-4b1c-a9e6-8d0179a2e98e2025-12-18WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN16650277-fa62-485e-9a82-7763d2b501688
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD16650277-fa62-485e-9a82-7763d2b501688
1020365benzalkonium chloride 0.13 % Topical FoamSY16650277-fa62-485e-9a82-7763d2b501688

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78181-020-027818100200250 mL in 1 BOTTLE, PUMP (78181-020-02) 50 ml2020-04-010000-00-00NoNoCurrent
78181-020-0778181002007221 mL in 1 BOTTLE, PUMP (78181-020-07) 221 ml2020-04-010000-00-00NoNoCurrent
78181-020-1878181002018550 mL in 1 BOTTLE, PUMP (78181-020-18) 550 ml2020-04-010000-00-00NoNoCurrent
78181-020-28781810020283785 mL in 1 JUG (78181-020-28) 3785 ml2020-04-010000-00-00NoNoCurrent