FDA.reportPublic FDA data

FIRST AID BURN

Product NDC
82749-009
Requested package NDC
82749-009-01
11-digit product format
827490009
Labeler code
82749
Product ID
82749-009_1a16f726-8d68-59a6-e063-6394a90a9278
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Epic Medical Supply Corp
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-01
Substance
LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE
Active strength
5; 1.3 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 BURN
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup
F5UM2KM3W7Internal 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
bd1b1873-e900-45eb-96a0-28f782b5a7cdAvailable 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
82749-009-01FIRST AID BURN0.9 g in 1 PACKETCREAM0.91
82749-009-01FIRST AID BURN144 in 1 BOXCREAM1441

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82749-009FIRST AID BURN (LIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE) CREAM [EPIC MEDICAL SUPPLY CORP]1Current NDC, 2 package rows20240606_bd1b1873-e900-45eb-96a0-28f782b5a7cd.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 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
ZIMS MAX FREEZELIDOCAINE HYDROCHLORIDE AND MENTHOL,KOBAYASHI Healthcare International, Inc.e364ff83-4aaf-4897-a7da-06581bc321f22025-12-18WarningsExact identifier
application number: M017
Tiger Balm White Regular StrengthCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.f406161e-a9c4-47d1-8b21-93b1b79380632025-12-17WarningsExact identifier
application number: M017
ResinolPETROLATUM AND RESORCINOLResiCal, Inc.03f57a4a-f94b-4ba6-b709-41cfb6e162612025-12-17WarningsExact identifier
application number: M017
HealthWise Maximum Pain ReliefLIDOCAINEVeridian Healthcareafc3c16d-0076-44b2-ae7e-5f36d4d8088e2025-12-17WarningsExact identifier
application number: M017
HealthWise Max Lidocaine plus MentholLIDOCAINE, MENTHOLVeridian Healthcaref39a27da-6799-4fc6-97ca-101eac4a93602025-12-17WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSNbd1b1873-e900-45eb-96a0-28f782b5a7cd1
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCDbd1b1873-e900-45eb-96a0-28f782b5a7cd1
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSYbd1b1873-e900-45eb-96a0-28f782b5a7cd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82749-009-0182749000901144 PACKET in 1 BOX (82749-009-01) / .9 g in 1 PACKET144 packet2024-06-01NoNoCurrent