FDA.reportPublic FDA data

Burn Treatment

Product NDC
49687-0014
11-digit product format
496870014
Labeler code
49687
Product ID
49687-0014_2b9b619a-5e29-73ef-e063-6394a90a97fe
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
CMC Group Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-08-06
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength
.13; .5 g/100g; g/100g
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

Additional Listing Data#

Finished product
Yes
Brand name base
Burn Treatment
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100g
LIDOCAINE HYDROCHLORIDE.5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7, V13007Z41A
Rxcui1012100

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
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
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
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49687-0014-02025-01-14C16284748780-11030e365-5a27-111a-e063-dadaa90a10e2Burn Treatment
49687-0014-02024-01-30C16284748780-11030e365-5a27-111a-e063-dadaa90a10e2Burn Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49687-0014-0Large ANSI First Aid Kit0.9 g in 1 POUCHCREAM9 g0.13 g in 100g15
49687-0014-0Large ANSI First Aid Kit10 in 1 KITCREAM0.13 g in 100g15
49687-0014-0Standard ANSI First Aid0.9 g in 1 POUCHCREAM9 g0.13 g in 100g13
49687-0014-0Standard ANSI First Aid10 in 1 KITCREAM0.13 g in 100g13
49687-0014-0Burn Treatment0.9 g in 1 POUCHCREAM0.96
49687-0014-0Burn Treatment10 in 1 KITCREAM106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49687-0014LARGE ANSI FIRST AID KIT (WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE) KIT [CMC GROUP, INC.]15Current NDC, Legacy NDC20250406_fa8578c2-a0bc-4e2e-a4f9-d48debfff378.zip
49687-0014STANDARD ANSI FIRST AID (WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE) KIT [CMC GROUP, INC.]13Current NDC, Legacy NDC20250406_e1ef74bf-8895-4200-a411-f726dcdaa945.zip
49687-0014BURN TREATMENT (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [CMC GROUP INC.]6Current NDC, Legacy NDC, 2 package rows20250116_9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSNfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSNfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1038558benzalkonium chloride 0.13 % Medicated PadPSNfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
581660ethanol 62 % Topical GelPSNfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
797544isopropyl alcohol 70 % Medicated PadPSNfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1053429water 99.1 % Ophthalmic Irrigation SolutionPSNfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCDfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
581660ethanol 0.62 ML/ML Topical GelSCDfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1053429water 991 MG/ML Ophthalmic Irrigation SolutionSCDfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1038558benzalkonium chloride 0.13 % Topical ClothSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1038558benzalkonium chloride 0.13 % Topical SwabSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
581660ethanol 62 % Topical GelSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
797544isopropyl alcohol 70 % Medicated PadSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
797544isopropyl alcohol 70 % Topical ClothSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
797544isopropyl alcohol 70 % Topical SwabSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1053429water 99.05 % Ophthalmic Irrigation SolutionSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1053429water 99.1 % Ophthalmic Irrigation SolutionSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
1053429water 99.1 ML per 100 ML Ophthalmic Irrigation SolutionSYfa8578c2-a0bc-4e2e-a4f9-d48debfff37815
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSNe1ef74bf-8895-4200-a411-f726dcdaa94513
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSNe1ef74bf-8895-4200-a411-f726dcdaa94513
1038558benzalkonium chloride 0.13 % Medicated PadPSNe1ef74bf-8895-4200-a411-f726dcdaa94513
581660ethanol 62 % Topical GelPSNe1ef74bf-8895-4200-a411-f726dcdaa94513
797544isopropyl alcohol 70 % Medicated PadPSNe1ef74bf-8895-4200-a411-f726dcdaa94513
1053429water 99.1 % Ophthalmic Irrigation SolutionPSNe1ef74bf-8895-4200-a411-f726dcdaa94513
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDe1ef74bf-8895-4200-a411-f726dcdaa94513
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCDe1ef74bf-8895-4200-a411-f726dcdaa94513
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDe1ef74bf-8895-4200-a411-f726dcdaa94513
581660ethanol 0.62 ML/ML Topical GelSCDe1ef74bf-8895-4200-a411-f726dcdaa94513
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDe1ef74bf-8895-4200-a411-f726dcdaa94513
1053429water 991 MG/ML Ophthalmic Irrigation SolutionSCDe1ef74bf-8895-4200-a411-f726dcdaa94513
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1038558benzalkonium chloride 0.13 % Topical ClothSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1038558benzalkonium chloride 0.13 % Topical SwabSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYe1ef74bf-8895-4200-a411-f726dcdaa94513
581660ethanol 62 % Topical GelSYe1ef74bf-8895-4200-a411-f726dcdaa94513
797544isopropyl alcohol 70 % Medicated PadSYe1ef74bf-8895-4200-a411-f726dcdaa94513
797544isopropyl alcohol 70 % Topical ClothSYe1ef74bf-8895-4200-a411-f726dcdaa94513
797544isopropyl alcohol 70 % Topical SwabSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1053429water 99.05 % Ophthalmic Irrigation SolutionSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1053429water 99.1 % Ophthalmic Irrigation SolutionSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1053429water 99.1 ML per 100 ML Ophthalmic Irrigation SolutionSYe1ef74bf-8895-4200-a411-f726dcdaa94513
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce406
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce406
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce406

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49687-0014-04968700140010 POUCH in 1 KIT (49687-0014-0) / .9 g in 1 POUCH10 pouch2016-08-060000-00-00NoNoCurrent