FDA.reportPublic FDA data

Dermal Wound Cleanser

Product NDC
69740-490
Requested package NDC
69740-490-00
11-digit product format
697400490
Labeler code
69740
Product ID
69740-490_1d4e61fc-0bf2-fb51-e063-6294a90a21fe
Type
HUMAN OTC DRUG
Nonproprietary name
BENZETHONIUM CHLORIDE
Dosage form
SPRAY
Route
TOPICAL
Labeler
Smith & Nephew Medical Ltd.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1994-04-01
Substance
BENZETHONIUM CHLORIDE
Active strength
1.3 g/981mL
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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
Dermal Wound Cleanser
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZETHONIUM CHLORIDE1.3 g/981mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PH41D05744Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
582205Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
18704cd5-1ecf-4e8c-9897-7e45394e68c8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69740-490-002024-07-15C16284748780-1f386c64a-2b85-0266-e053-dadaa90a7c1aDermal Wound Cleanser
69740-490-002023-01-30C16284748780-1f386c64a-2b85-0266-e053-dadaa90a7c1aDermal Wound Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69740-490-00Dermal Wound Cleanser473 mL in 1 BOTTLE, SPRAYSPRAY4735

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D05744DERMAL WOUND CLEANSER (BENZETHONIUM CHLORIDE) SPRAY [SMITH & NEPHEW MEDICAL LTD.]1
BENZETHONIUMACTIVE MOIETY1VU15B70BPDERMAL WOUND CLEANSER (BENZETHONIUM CHLORIDE) SPRAY [SMITH & NEPHEW MEDICAL LTD.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDERMAL WOUND CLEANSER (BENZETHONIUM CHLORIDE) SPRAY [SMITH & NEPHEW MEDICAL LTD.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDERMAL WOUND CLEANSER (BENZETHONIUM CHLORIDE) SPRAY [SMITH & NEPHEW MEDICAL LTD.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDERMAL WOUND CLEANSER (BENZETHONIUM CHLORIDE) SPRAY [SMITH & NEPHEW MEDICAL LTD.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDERMAL WOUND CLEANSER (BENZETHONIUM CHLORIDE) SPRAY [SMITH & NEPHEW MEDICAL LTD.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHDERMAL WOUND CLEANSER (BENZETHONIUM CHLORIDE) SPRAY [SMITH & NEPHEW MEDICAL LTD.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDERMAL WOUND CLEANSER (BENZETHONIUM CHLORIDE) SPRAY [SMITH & NEPHEW MEDICAL LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RDERMAL WOUND CLEANSER (BENZETHONIUM CHLORIDE) SPRAY [SMITH & NEPHEW MEDICAL LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69740-490DERMAL WOUND CLEANSER (BENZETHONIUM CHLORIDE) SPRAY [SMITH & NEPHEW MEDICAL LTD.]5Current NDC, Legacy NDC, 1 package rows20240716_18704cd5-1ecf-4e8c-9897-7e45394e68c8.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 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMORA Spray. Hand Sanitizer coconutALCOHOLLongway Technology(Guangzhou) Co., Ltd.44fcf3d3-439b-7869-e063-6294a90a19c32025-12-02WarningsExact identifier
application number: M003
MedPride Instant SanitizerALCOHOLSHIELD LINE LLCa1c87c06-d4d2-cd0f-e053-2995a90a4eaa2025-12-02WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Caramel HoneyALCOHOLShenzhen Lantern Scicence Co.,Ltd.450401c9-2098-9a23-e063-6394a90a20842025-12-02WarningsExact identifier
application number: M003
AMORA Spray. Hand Sanitizer CherryALCOHOLLongway Technology(Guangzhou) Co., Ltd.44e04959-a21e-ba62-e063-6394a90a71922025-12-01WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLL&R Distributors, Inc.263457cc-35ff-62fb-e063-6394a90a94da2025-12-01WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLL&R Distributors, Inc.2507df2c-9069-01c1-e063-6394a90a85962025-12-01WarningsExact identifier
application number: M003
T.N. Dickinsons Wound CleansingBENZALKONIUM CHLORIDE, PRAMOXINE HYDROCHLORIDEDickinson Brands Inc.c2a8b134-8bb3-4e00-9df4-3229cb372da02025-12-01WarningsExact identifier
application number: M003
safeHands Hand Sanitizer Clean LinenBENZALKONIUM CHLORIDESafehands Distribution Ne, LLC86cc04dc-b66d-4d97-b8da-f5e41f2d13d52025-11-29WarningsExact identifier
application number: M003
safeHands Hand Sanitizer Fragrance FreeBENZALKONIUM CHLORIDESafehands Distribution Ne, LLC0e7af9f7-80a1-4347-89c4-7d9c8b55d65d2025-11-29WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLC5376a031-b657-47d4-bf41-c393fdec040b2025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLC2298e131-3b0c-4104-bf48-5c366d763d452025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLCbe8b96a2-c4a2-41f8-959b-0fe349cff37e2025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLCb35cb3d0-1a2d-4ffc-a32e-faa2ca1312ee2025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLCcef2d3d4-bd5f-4f2a-bb2d-5292b78501c12025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLC90d6fe21-7b41-4429-8c03-4d35e66a3b292025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLC87aaabb6-d121-464f-993d-5182de13d49e2025-11-28WarningsExact identifier
application number: M003
FF SILICONE SPRY SANI PPKFF SILICONE SPRY SANI PPKZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD4493c534-187e-f680-e063-6294a90aacdb2025-11-27WarningsExact identifier
application number: M003
Walgreen Maximum strength pain relieving cleansingBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEWALGREENS CO.9a0443a2-f1a9-482d-b5ee-abe983e4ae322025-11-26WarningsExact identifier
application number: M003
WalgreensFIRST AID ANTISEPTICWalgreensae731d28-8530-4dd0-aef7-b25f784b47772025-11-26WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.44677bab-41ea-3392-e063-6394a90a61872025-11-25WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582205benzethonium chloride 0.13 % Topical SprayPSN18704cd5-1ecf-4e8c-9897-7e45394e68c85
582205benzethonium chloride 1.3 MG/ML Topical SpraySCD18704cd5-1ecf-4e8c-9897-7e45394e68c85
582205benzethonium chloride 0.13 % Topical SpraySY18704cd5-1ecf-4e8c-9897-7e45394e68c85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69740-490-0069740049000473 mL in 1 BOTTLE, SPRAY (69740-490-00) 473 ml1994-04-010000-00-00NoNoCurrent