FDA.reportPublic FDA data

First Aid Only First Aid/Burn

Product NDC
0924-5011
11-digit product format
009245011
Labeler code
0924
Product ID
0924-5011_27225914-f582-736b-e063-6394a90ad1c5
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Hydrochloride and Benzalkonium Chloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Acme United Corporation
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-08-30
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 Only 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
caa67a05-bdbd-c380-e053-2995a90a0bf1Available 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
0924-5011-00First Aid Only First Aid/Burn0.9 g in 1 PACKETCREAM0.92
0924-5011-01First Aid Only First Aid/Burn10 in 1 CARTONCREAM102
0924-5011-01First Aid Only First Aid/Burn0.9 g in 1 PACKETCREAM0.92
0924-5011-02First Aid Only First Aid/Burn0.9 g in 1 PACKETCREAM0.92
0924-5011-02First Aid Only First Aid/Burn12 in 1 CARTONCREAM122
0924-5011-03First Aid Only First Aid/Burn0.9 g in 1 PACKETCREAM0.92
0924-5011-03First Aid Only First Aid/Burn25 in 1 CARTONCREAM252
0924-5011-04First Aid Only First Aid/Burn0.9 g in 1 PACKETCREAM0.92
0924-5011-04First Aid Only First Aid/Burn144 in 1 CARTONCREAM1442

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-5011FIRST AID ONLY FIRST AID/BURN (LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE) CREAM [ACME UNITED CORPORATION]2Current NDC, Legacy NDC, 9 package rows20241119_caa67a05-bdbd-c380-e053-2995a90a0bf1.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 101 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Magsoothium CBD Cooling Roll on ReliefMENTHOLUbu/Elements, Inc.2cf05dcd-6a44-de08-e063-6394a90aaba02025-01-30WarningsExact identifier
application number: M017
Meijer Vagicaine20% BENZOCAINE AND 3% RESORCINOL CREAMMeijer, Inc.dac73a07-7569-4788-977a-f10d098da75d2025-01-30WarningsExact identifier
application number: M017
ZCort UltraHYDROCORTISONE ACETATE 1%RxDino, LLCb68f8ada-58e8-e8e4-e053-2a95a90ab02d2025-01-29WarningsExact identifier
application number: M017
Lidocaine Pain Relieving Gel-PatchLIDOCAINE 4%Noble OTC LLC12a3ce63-6fce-0993-e063-6294a90a40d52025-01-28WarningsExact identifier
application number: M017
INTIMALE LIDOCAINE DELAYLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED5ddd7d56-bf51-462b-afcd-944861e497812025-01-28WarningsExact identifier
application number: M017
CBD Clinic Relax MassageCAMPHORABACUS HEALTH PRODUCTS, INC.f0eae24e-09cf-0d2d-e053-2a95a90acedc2025-01-28WarningsExact identifier
application number: M017
CBD Clinic Pain Relief - Level 5MENTHOL, CAMPHORABACUS HEALTH PRODUCTS, INC.f0ebbc0f-9888-b812-e053-2a95a90a5d3d2025-01-28WarningsExact identifier
application number: M017
CBDMEDIC Arthritis Aches and Pain ReliefCAMPHOR AND MENTHOLABACUS HEALTH PRODUCTS, INC.f0ec7255-bb36-41cd-e053-2a95a90aeac42025-01-28WarningsExact identifier
application number: M017
CBDMEDIC Back and Neck Pain ReliefCAMPHOR AND MENTHOLABACUS HEALTH PRODUCTS, INC.f0ec8fc9-c401-5f23-e053-2995a90acb1c2025-01-28WarningsExact identifier
application number: M017
Muscle TherapyMETHYL SALICYLATE, CAMPHOREverlaan Organics Inc0890a683-9a66-fdbd-e063-6294a90ae5262025-01-27WarningsExact identifier
application number: M017
Joint TherapyCAMPHOREverlaan Organics Inc08904b77-d6db-8b82-e063-6394a90ace4f2025-01-27WarningsExact identifier
application number: M017
Warrior Arthritis ReliefTROLAMIN SALICYLATE 10%Derma Care Research Labs, LLC013f48b9-913f-b283-e063-6394a90abd732025-01-27WarningsExact identifier
application number: M017
DCH Cool and HeatMENTHOL 16%Derma Care Research Labs, LLCff323282-612c-eaf8-e053-6394a90ab7792025-01-27WarningsExact identifier
application number: M017
GerigentleHYDROCORTISONEGERI-GENTLE CORPORATION0adfa2f0-9758-5c54-e063-6294a90a461f2025-01-25WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pain RelievingMENTHOL, CAMPHORActive and Innovative Inc.42f1abeb-f6d7-01c3-e054-00144ff88e882025-01-23WarningsExact identifier
application number: M017
FORTHiQ Pain Relief Lidocaine PatchPAIN RELIEF LIDOCAINE PATCHHenan Enokon Medical Instrument Co., Ltd.2c593420-5788-3422-e063-6394a90a18902025-01-22WarningsExact identifier
application number: M017
RETALIEF LIDOCAINE 5LIDOCAINEReliable 1 Laboratories LLC2c262f3c-8cb2-4384-e063-6294a90a436d2025-01-20WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEBorden Company (Private) Limited1c3e5068-dd61-ebdb-e063-6294a90a97cc2025-01-20WarningsExact identifier
application number: M017
PROHEAL BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.bbc0a5d6-1de6-4ca3-9bb4-a45662b5eab12025-01-19WarningsExact identifier
application number: M017
HERSTAT PLUS Cold Sore TreatmentCAMPHOR, MENTHOLHerstat (USA) Inc.e20ea714-663d-c4ac-e053-2a95a90a5ecc2025-01-18WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSNcaa67a05-bdbd-c380-e053-2995a90a0bf12
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCDcaa67a05-bdbd-c380-e053-2995a90a0bf12
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSYcaa67a05-bdbd-c380-e053-2995a90a0bf12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0924-5011-0000924501100.9 g in 1 PACKET (0924-5011-00) 2021-08-300000-00-00NoNoCurrent
0924-5011-010092450110110 PACKET in 1 CARTON (0924-5011-01) / .9 g in 1 PACKET10 packet2021-08-300000-00-00NoNoCurrent
0924-5011-020092450110212 PACKET in 1 CARTON (0924-5011-02) / .9 g in 1 PACKET12 packet2021-08-300000-00-00NoNoCurrent
0924-5011-030092450110325 PACKET in 1 CARTON (0924-5011-03) / .9 g in 1 PACKET25 packet2021-08-300000-00-00NoNoCurrent
0924-5011-0400924501104144 PACKET in 1 CARTON (0924-5011-04) / .9 g in 1 PACKET144 packet2021-08-300000-00-00NoNoCurrent