FDA.reportPublic FDA data

First Aid Only First Aid-Burn

Product NDC
0924-5702
Requested package NDC
0924-5702-01
11-digit product format
009245702
Labeler code
0924
Product ID
0924-5702_2990220d-65fc-79b0-e063-6394a90a1736
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride, Lidocaine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Acme United Corporation
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-30
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength
1.3; 5 mg/g; mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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
First Aid Only First Aid-Burn
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/g
LIDOCAINE HYDROCHLORIDE5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup
V13007Z41AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1012100Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f31a44ff-e4ac-de1e-e053-2a95a90ab036Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0924-5702-00First Aid Only First Aid-Burn0.9 g in 1 PACKETCREAM0.94
0924-5702-01First Aid Only First Aid-Burn0.9 g in 1 PACKETCREAM0.94
0924-5702-01First Aid Only First Aid-Burn6 in 1 CARTONCREAM64
0924-5702-02First Aid Only First Aid-Burn10 in 1 CARTONCREAM104
0924-5702-02First Aid Only First Aid-Burn0.9 g in 1 PACKETCREAM0.94
0924-5702-03First Aid Only First Aid-Burn12 in 1 CARTONCREAM124
0924-5702-03First Aid Only First Aid-Burn0.9 g in 1 PACKETCREAM0.94
0924-5702-04First Aid Only First Aid-Burn20 in 1 CARTONCREAM204
0924-5702-04First Aid Only First Aid-Burn0.9 g in 1 PACKETCREAM0.94
0924-5702-05First Aid Only First Aid-Burn0.9 g in 1 PACKETCREAM0.94
0924-5702-05First Aid Only First Aid-Burn25 in 1 CARTONCREAM254
0924-5702-06First Aid Only First Aid-Burn60 in 1 CARTONCREAM604
0924-5702-06First Aid Only First Aid-Burn0.9 g in 1 PACKETCREAM0.94
0924-5702-07First Aid Only First Aid-Burn0.9 g in 1 PACKETCREAM0.94
0924-5702-07First Aid Only First Aid-Burn144 in 1 CARTONCREAM1444

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-5702FIRST AID ONLY FIRST AID-BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [ACME UNITED CORPORATION]4Current NDC, 15 package rows20241220_f31a44ff-e4ac-de1e-e053-2a95a90ab036.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 97 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maokang 10 Povidone IodinePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd7c17ce40-0358-44ff-aa60-53711666914b2024-11-21WarningsExact identifier
application number: M003
MK Alcohol Prep Pads MediumISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd11390854-9e72-40a2-9c89-3c29a585dced2024-11-21WarningsExact identifier
application number: M003
Instant Hand Sanitizeing WipeISOPROPANOL AND COMPOUND DOUBLE-STRANDED QUATERNARY AMMONIUM SALTSShandong Yayun Sanitary Products Co., Ltd.aa0dc01a-2c6b-7402-e053-2a95a90af6a22024-11-21WarningsExact identifier
application number: M003
Dynarex Povidone Iodine Prep SolutionPOVIDONE IODINE PREP SOLUTIONDynarex Corporation6bb4d55b-2be7-3549-e053-2a91aa0a2bb02024-11-20WarningsExact identifier
application number: M003
Dynarex Povidone Iodine Surgical ScrubPOVIDONE IODINE SURGICAL SCRUB SOLUTIONDynarex Corporation6f053e55-cbf6-9072-e053-2991aa0a2edd2024-11-20WarningsExact identifier
application number: M003
Dynarex GreenALCOHOLDynarex Corporation072572be-49dd-4594-bc40-b56db57ada5b2024-11-20WarningsExact identifier
application number: M003
Dynarex GreenCHLOROXYLENOLDynarex Corporation59b098d2-08de-4fdb-a209-ae226abf37d62024-11-20WarningsExact identifier
application number: M003
Baby WipesPROPYLENE GLYCOLShandong Yayun Sanitary Products Co., Ltd.aeb9a12c-955f-5030-e053-2995a90a2dd62024-11-20WarningsExact identifier
application number: M003
Pet wipesBENZALKONIUM CHLORIDEShandong Yayun Sanitary Products Co., Ltd.2764ea79-32d8-b7f6-e063-6394a90a55012024-11-20WarningsExact identifier
application number: M003
Premium Hand SanitizerETHANOLMCKESSON MEDICAL-SURGICAL INC.a9514466-e0c6-4792-984a-9f07d94ee8872024-11-18WarningsExact identifier
application number: M003
MARVEL BZK ANTISEPTIC WIPEBENZALKONIUM CHLORIDEAshtel Studios, Inc.93ed0bb4-834d-44ca-9c0a-20086fc09ab82024-11-18WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMcKesson Medical-Surgical Inc.98b0bcc2-539b-4471-ba98-bbe17bb881bd2024-11-15WarningsExact identifier
application number: M003
CVS Health Hydrogen Peroxide WipesHYDROGEN PEROXIDECVS PHARMACY, INC7a930a5e-5b69-428f-9cbb-d03dae1802952024-11-12WarningsExact identifier
application number: M003
First Aid Only Povidone-Iodine Prep PadPOVIDONE-IODINEAcme United Corporation509b6c8e-6a9f-2656-e054-00144ff8d46c2024-11-09WarningsExact identifier
application number: M003
MED NAP Cleansing ToweletteBENZALKONIUM CHLORIDEAcme United Corporationd92cd45a-234c-4872-e053-2a95a90a3e1c2024-11-09WarningsExact identifier
application number: M003
MED NAP Obstetrical ToweletteBENZALKONIUM CHLORIDEAcme United Corporationd83d2fab-6972-9b18-e053-2995a90a5cb52024-11-09WarningsExact identifier
application number: M003
MED NAP Benzalkonium Chloride AntisepticBENZALKONIUM CHLORIDEAcme United Corporationd7c404c1-c765-a67c-e053-2995a90a6b8e2024-11-09WarningsExact identifier
application number: M003
Barbie BZK ANTISEPTIC WIPEBENZALKONIUM CHLORIDEAshtel Studios, Inc.d675eb91-80a8-4874-a2b0-c2bf692649112024-11-08WarningsExact identifier
application number: M003
Barbie ALCOHOL WIPEISOPROPYL ALCOHOLAshtel Studios, Inc.a4a6beb0-5781-4d74-9120-7ca64e035c232024-11-08WarningsExact identifier
application number: M003
MARVEL ALCOHOL WIPEISOPROPYL ALCOHOLAshtel Studios, Inc.f6cd4757-d6e0-46bd-827f-3f380c71858f2024-11-07WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSNf31a44ff-e4ac-de1e-e053-2a95a90ab0364
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCDf31a44ff-e4ac-de1e-e053-2a95a90ab0364
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSYf31a44ff-e4ac-de1e-e053-2a95a90ab0364

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0924-5702-01009245702016 PACKET in 1 CARTON (0924-5702-01) / .9 g in 1 PACKET6 packet2024-12-31NoNoCurrent