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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49687-0014-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49687-0014-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49687-0014-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49687-0014-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage49687-0014-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage49687-0014-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage49687-0014-01332a3947898…d4bfe170f9cd…

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
Burn Treatment
Listing expiration
2026-12-31

Active Ingredients#

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

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
9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce40Available 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
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

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 2 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WalmartISOPROPYL ALCOHOLWalmart, Inc.2eff98ba-5736-b07e-e063-6394a90aeea92026-09-04WarningsExact identifier
application number: M003
Walgreen AlcoholISOPROPYL ALCOHOLWalgreens Companydeeae1ea-3d81-4260-95be-c4f328e3fdef2026-09-04WarningsExact identifier
application number: M003
Dollar GeneralISOPROPYL ALCOHOLDollar General Corporation00b2ef34-42d9-523c-e063-6294a90a753d2026-09-03WarningsExact identifier
application number: M003
Signature Select Alcohol Prep PadsISOPROPYL ALCOHOLBetter Living Brands LLC31ce72e3-03a3-1608-e063-6394a90ad8502026-09-03WarningsExact identifier
application number: M003
SurviveX Sting ReliefSTING RELIEF WIPEChangzhou Maokang Medical Products Co., Ltd.5a83b1f1-c8dc-cf07-e063-6394a90a20ca2026-09-03WarningsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEKroger Co.fe604470-917f-4cbd-a1e6-ac1dc7c57ff62026-09-02WarningsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLRite Aid Corporation5104f9ab-0b28-449f-a55a-5438713a24df2026-09-02WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEUpLift Brands, LLC5a81b635-d188-0b29-e063-6294a90a1e4b2026-09-02Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDECVS Pharmacy, Inc.7f518646-c8fe-499a-b5e4-8e5a5a90e01d2026-09-02Warnings, Adverse reactionsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLThe Kroger Company6551187f-5cde-4149-931f-b057bd7607502026-09-02WarningsExact identifier
application number: M003
Unscented NasalGuard Antiseptic TopicalBENZALKONIUM CHLORIDETRUTEK CORP.eb036e11-a28c-fdc0-e053-2a95a90a9cdb2026-09-02WarningsExact identifier
application number: M003
Harris TeeterISOPROPYL ALCOHOLHarris Teeter, LLCd2bb20bd-ec83-8d80-e053-2a95a90a2bba2026-09-02WarningsExact identifier
application number: M003
School HealthISOPROPYL ALCOHOLSchool Health Corporationdb5d0b22-f2d7-23e5-e053-2a95a90aeb512026-09-02WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLTopco Associates2642298f-607e-fdca-e063-6394a90a69d92026-09-02WarningsExact identifier
application number: M003
HUSTLE BUTTER NUMBINGLIDOCAINE HCL, BENZALKONIUM CHLORIDEH.B.D. DIST. INC.5b4d0390-dac6-4a71-9fdc-5c31543e7c5a2026-09-02WarningsExact identifier
application number: M003
NasalGuard Antiseptic Topical Cool MentholBENZALKONIUM CHLORIDETRUTEK CORP.e9fd3ef8-78ff-6c9f-e053-2a95a90a21a82026-09-01WarningsExact identifier
application number: M003
Maximum Strength Betadine ClearBENZALKONIUM CL AND PRAMOXINE HCLAtlantis Consumer Healthcare, Inc.31b94a76-1536-47c0-ab03-e487c2625c582026-08-31WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a28101f-ea8e-6071-e063-6294a90aad912026-08-31WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a3e62ce-52dc-121b-e063-6294a90a898f2026-08-31WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a49db18-c270-6f46-e063-6294a90afb5d2026-08-31WarningsExact identifier
application number: M003

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