FDA.reportPublic FDA data

First Aid and Burn

Product NDC
61010-5701
11-digit product format
610105701
Labeler code
61010
Product ID
61010-5701_10d3fc91-82a0-e8eb-e063-6394a90ae87b
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride, Lidocaine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Safetec of America, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-09-21
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
2027-12-31
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 and Burn
Listing expiration
2027-12-31

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
47cb6921-5d82-4123-a9e0-0b05d4dcb5b2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
61010-5701-42024-02-0761010-5701, First Aid and Burn Cream
61010-5701-52024-02-0761010-5701, First Aid and Burn Cream
61010-5701-62024-02-0761010-5701, First Aid and Burn Cream
61010-5701-42024-01-3061010-5701, First Aid and Burn Cream
61010-5701-52024-01-3061010-5701, First Aid and Burn Cream
61010-5701-62024-01-3061010-5701, First Aid and Burn Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-5701-3First Aid and Burn0.9 g in 1 PACKETCREAM0.95
61010-5701-4First Aid and Burn144 in 1 BOXCREAM1445
61010-5701-5First Aid and Burn25 in 1 BOXCREAM255
61010-5701-6First Aid and Burn10 in 1 BOXCREAM105

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
benzalkonium chlorideACTIVE INGREDIENTF5UM2KM3W7FIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.]1
lidocaine hydrochlorideACTIVE INGREDIENTV13007Z41AFIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.]1
benzalkoniumACTIVE MOIETY7N6JUD5X6YFIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.]1
lidocaineACTIVE MOIETY98PI200987FIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.]1
alcoholINACTIVE INGREDIENT3K9958V90MFIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.]1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XFIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TFIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPFIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.]1
paraffinINACTIVE INGREDIENTI9O0E3H2ZEFIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UFIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHFIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RFIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.]1
white waxINACTIVE INGREDIENT7G1J5DA97FFIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-5701FIRST AID AND BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [SAFETEC OF AMERICA, INC.]5Current NDC, Legacy NDC, 4 package rows20240208_47cb6921-5d82-4123-a9e0-0b05d4dcb5b2.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 58 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Prep PadsISOPROPYL ALCOHOLCardinal Health5459a0b4-65ca-455e-80b2-3fe1b24e01372025-10-23WarningsExact identifier
application number: M003
Hand Sanitizing WipesETHYL ALCOHOLPhoenix Healthcare Solutions LLCc68d2d73-be78-8e1c-e053-2995a90a3a372025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLCa7d77afc-588d-47d7-be2f-686ff3d75da22025-10-23WarningsExact identifier
application number: M003
Hand Sanitizing WipesETHYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLCca9f8e68-cc15-42b4-81fd-e114e6a6d7df2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC50b24287-4c91-43d2-9c2e-42d3c086b3b32025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC51b707c6-df09-441b-a3d1-3f0c1b0886cc2025-10-23WarningsExact identifier
application number: M003
Povidone Iodine Prep SwabstickPOVIDONE IODINEPHOENIX HEALTHCARE SOLUTIONS, LLC8a0aba34-3f96-46b6-8521-f4388fb73edf2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC9c34be37-b6e2-4c08-96a5-d9bb0e738f2d2025-10-23WarningsExact identifier
application number: M003
Alcohol Swab SticksISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC91a9d6f7-d16c-46bf-8389-a6771e3ebfba2025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC9d79480c-ceef-49f7-a830-171c2a2629392025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLCardinal Health 200, Inc.a1bccbf5-9cee-46c0-890c-02eb3577c1932025-10-23WarningsExact identifier
application number: M003
Alcohol WipesISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC04c2ac54-1f44-a5d2-e063-6394a90a99cc2025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC2a160c89-c438-455d-910d-ac359d46786f2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCe917b371-3ca9-94f0-e053-2a95a90af8ad2025-10-23WarningsExact identifier
application number: M003
Lemon Glycerine SwabsticksGLYCERINEPHOENIX HEALTHCARE SOLUTIONS, LLC436919f7-14cd-4318-9388-b3e1cbec176b2025-10-23WarningsExact identifier
application number: M003
CareTouch Alcohol Prep PadISOPROPYL ALCOHOLFuture Diagnostics Llc91cfd7bf-9f42-49d5-b20d-281779d5272d2025-10-23WarningsExact identifier
application number: M003
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEPHOENIX HEALTHCARE SOLUTIONS, LLCdab5e937-bd92-467b-b1ac-a2428a814bc32025-10-23WarningsExact identifier
application number: M003
Alcohol WipeISOPROPYL ALCOHOLWalmart Inc.067c3983-d450-e86b-e063-6294a90ab7582025-10-23WarningsExact identifier
application number: M003
CareTouchETHYL ALCOHOLFuture Diagnostics Llc45f6a1da-f0ab-4783-a211-7fba5dc0530e2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC24337cc6-98fe-ca0b-e063-6394a90a8b7b2025-10-23WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN47cb6921-5d82-4123-a9e0-0b05d4dcb5b25
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD47cb6921-5d82-4123-a9e0-0b05d4dcb5b25
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY47cb6921-5d82-4123-a9e0-0b05d4dcb5b25
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 startMarketing endSampleExclude flagStatus
61010-5701-3610105701030.9 g in 1 PACKET0.9 gHistorical
61010-5701-461010570104144 PACKET in 1 BOX (61010-5701-4) / .9 g in 1 PACKET (61010-5701-3) 144 packet2012-09-210000-00-00NoNoCurrent
61010-5701-56101057010525 PACKET in 1 BOX (61010-5701-5) / .9 g in 1 PACKET (61010-5701-3) 25 packet2012-09-210000-00-00NoNoCurrent
61010-5701-66101057010610 PACKET in 1 BOX (61010-5701-6) / .9 g in 1 PACKET (61010-5701-3) 10 packet2020-04-010000-00-00NoNoCurrent