FDA.reportPublic FDA data

XTRA

Product NDC
84987-001
11-digit product format
849870001
Labeler code
84987
Product ID
84987-001_2fb7059d-5d89-3836-e063-6394a90a976c
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SPRAY
Route
TOPICAL
Labeler
Zhejiang Jifu Daily Chemical Co., Ltd.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-27
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
XTRA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
27df3fce-3958-d4ea-e063-6394a90a1785Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84987-001-01XTRA399 mL in 1 BOTTLE, SPRAYSPRAY3992

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84987-001XTRA (BENZALKONIUM CHLORIDE) SPRAY [ZHEJIANG JIFU DAILY CHEMICAL CO., LTD.]2Current NDC, 1 package rows20250309_27df3fce-3958-d4ea-e063-6394a90a1785.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 73 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer Coconut SandalwoodETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.3a186822-025c-6970-e063-6394a90a5dc12025-07-16WarningsExact identifier
application number: M003
X3 Clean Hand SanitizerBENZALKONIUM CHLORIDENatural Essentials, Inc.5a0aea16-b1ff-4fa1-a292-0f14474745932025-07-15WarningsExact identifier
application number: M003
Meridian Wrapped antibacterial deodorantBENZETHONIUM CHLORIDEBob Barker Company Inc.84aada12-f26e-4dc9-a256-8746c6431f612025-07-15WarningsExact identifier
application number: M003
Meridian Unwrapped antibacterial deodorantBENZETHONIUM CHLORIDEBob Barker Company Inc.2c124769-a044-4d62-9325-89d5310a42de2025-07-15WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLAmerisourceBergen (Good Neighbor Pharmacy) 461225539cbe8-1d0f-41f8-9c5d-a9af7f28eed12025-07-15WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd39a417a8-afec-f893-e063-6394a90a70ae2025-07-11WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd39a4aecf-1e74-4589-e063-6394a90a34fb2025-07-11WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd39a57c83-5ea6-5b36-e063-6294a90a284d2025-07-11WarningsExact identifier
application number: M003
terrasil First Aid Antiseptic Wound and Burn CareHEXYLRESORCINOLAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions3cfa43a0-402b-4b32-94ff-2b2e2e6565c22025-07-11WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLCardinal Health (Leader) 70000bf355e30-ad2f-4f93-9d77-8efd6a908e582025-07-11WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70 Percent WintergreenISOPROPYL ALCOHOLBest Choice (Valu Merchandisers Company)abcc7941-e521-4ad6-89df-0b965b634eb32025-07-11WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLCardinal Health (Leader) 700005ffa8ecf-1349-4758-8d47-e9a96d2ddaee2025-07-11WarningsExact identifier
application number: M003
XTRA Antibacterial Hand Fresh LemonBENZALKONIUM CHLORIDEMY IMPORTS USA LLC.39904847-ed55-f4a3-e063-6294a90a85a12025-07-10WarningsExact identifier
application number: M003
XTRA Squeeze Antibacterial Hand Fresh LemonBENZALKONIUM CHLORIDEZhejiang Jifu Daily Chemical Co., Ltd.397a897a-baab-d209-e063-6294a90aac652025-07-10WarningsExact identifier
application number: M003
XTRA Antibacterial Hand Fresh LemonBENZALKONIUM CHLORIDEZhejiang Jifu Daily Chemical Co., Ltd.398fd961-d5e6-9d40-e063-6294a90a5be52025-07-10WarningsExact identifier
application number: M003
XTRA Squeeze Antibacterial Hand Fresh LemonBENZALKONIUM CHLORIDEMY IMPORTS USA LLC.39901012-e1a1-c6e3-e063-6294a90ab41f2025-07-10WarningsExact identifier
application number: M003
AerowipeALCOHOL WIPEAero Healthcare34c93704-9f3c-6746-e054-00144ff8d46c2025-07-10WarningsExact identifier
application number: M003
Walgreens 10 Povidone-Iodine SolutionPOVIDONE-IODINEWALGREEN COMPANYa7b635d0-9109-4cd6-9b96-fba0d76464fc2025-07-10WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLSafeway, Inc.502b09be-b7e6-4ad7-be17-4c8b0e93b4ab2025-07-07WarningsExact identifier
application number: M003
Signature Select isopropyl alcohol wipesALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.97272c57-88f0-40d9-b11f-d53cb806ee732025-07-04WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84987-001-0184987000101399 mL in 1 BOTTLE, SPRAY (84987-001-01) 399 ml2024-11-27NoNoCurrent