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 25 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidoTapeLIDOCAINE 4%V2 Pharma LLCed18b4f7-6a2c-4dce-9b53-e485569093c52026-04-09WarningsExact identifier
application number: M017
TheraCare Lidocaine Pain ReliefLIDOCAINEVeridian Healthcare4f112ab2-b67a-a3e2-e063-6394a90acb602026-04-09WarningsExact identifier
application number: M017
TheraCare Pain ReliefMENTHOLVeridian Healthcare4f11aa1e-de53-a3b0-e063-6294a90a2fe42026-04-09WarningsExact identifier
application number: M017
TheraCare 2X Medicated Pain ReliefLIDOCAINE, MENTHOLVeridian Healthcare4f11fca1-1949-ab8e-e063-6394a90ac6272026-04-09WarningsExact identifier
application number: M017
TheraCare Medicated Pain ReliefCAMPHOR, MENTHOL, METHYL SALICYLATEVeridian Healthcare4f125062-af89-40d3-e063-6394a90a27ef2026-04-09WarningsExact identifier
application number: M017
DRMITSUI ECZEMA RELIEFHYDROCORTISONE 1% ECZEMA RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4eee7637-3a28-e0bd-e063-6294a90ae1a42026-04-08WarningsExact identifier
application number: M017
SINSIN MULPASL-MENTHOL, METHYL SALICYLATE, DL-CAMPHORSinsin Pharmaceutical Co., Ltd.47c077c2-6e34-8e7a-e063-6294a90a21b52026-04-08WarningsExact identifier
application number: M017
Yi Tiao Gen Pain PatchPAIN PATCHSheng Chang Pharmaceutical Co, Ltd. Zhongli Factory4828fe70-f6f8-45e4-9c9a-a9e486dc65e52026-04-07WarningsExact identifier
application number: M017
Dermatool Nerve CareLIDOCAINE HCL, MENTHOLPapalo Group, LLC4ee40c96-9350-4c68-e063-6294a90ac8122026-04-07WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINECVS Pharmacy, Inc.42b3c341-f422-b2b4-e063-6294a90a47b22026-04-06WarningsExact identifier
application number: M017
KinetiCream Pain Relieving Topical AnalgesicMENTHOLPhoenix Bioperformance Products LLCbb4c9e73-e62d-4b8c-a16c-b90db1a8b2a72026-04-06WarningsExact identifier
application number: M017
KinetiCream Anti-Inflammatory and Pain ReliefMENTHOLPhoenix Bioperformance Products LLC39a6d26b-b5f4-45d7-a9b5-6edbf42d75002026-04-06WarningsExact identifier
application number: M017
Dr. Blue PainZaway Pain Relieving Roll-OnMENTHOLIndiana Botanic Gardens4ecc8241-5a87-2f45-e063-6294a90aa30a2026-04-06WarningsExact identifier
application number: M017
Sunburn Relief GelLIDOCAINE HCLCVS Pharmacy, Inc.d7f52394-5cc1-48a6-ae89-9fc63b5157582026-04-06Warnings, Adverse reactionsExact identifier
application number: M017
Pain-Relieving PatchCAMPHOR, MENTHOL, METHYL SALICYLATECVS Pharmacy4ecf4a6e-5c0f-7943-e063-6394a90a81cc2026-04-06WarningsExact identifier
application number: M017
RAPID RELIEF0.025% CAPSAICIN PAIN PATCHRAPID AID VIET NAM COMPANY LIMITED4edbaa1a-6e44-4865-e063-6394a90a8cc32026-04-06WarningsExact identifier
application number: M017
Capsaicin 0.1% CreamCAPSAICIN 0.1%Puretek Corporation4e83441b-cb6a-beb0-e063-6394a90a1b542026-04-03WarningsExact identifier
application number: M017
NeroCare Capsaicin Neuropathy Relief CreamCAPSAICINGuangzhou Tata Biotechnology Co., Ltd.4e89b7eb-0d84-dc57-e063-6394a90a7dd92026-04-03WarningsExact identifier
application number: M017
TheraCare Pain Relief PatchLIDOCAINE 4%Veridian Healthcare4e91da65-8191-6261-e063-6394a90a6bd52026-04-03WarningsExact identifier
application number: M017
HealthWise Roll-OnLIDOCAINE, MENTHOLVeridian Healthcare4e9306b5-949e-f7a9-e063-6394a90ae13a2026-04-03WarningsExact 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