FDA.reportPublic FDA data

Medi-First Burn with Lidocaine

Product NDC
47682-270
11-digit product format
476820270
Labeler code
47682
Product ID
47682-270_0f26e626-4d6b-dfdf-e063-6294a90a4c99
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride, Lidocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Unifirst First Aid Corporation
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-01
Marketing end
2028-04-30
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength
1.3; 5 mg/g; mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
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
Medi-First Burn with Lidocaine

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/g
LIDOCAINE HYDROCHLORIDE5 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
bd46efc8-0b36-0931-e053-2a95a90adb6fAvailable 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
47682-270-12Medi-First Burn with Lidocaine0.9 g in 1 PACKETCREAM0.96
47682-270-12Medi-First Burn with Lidocaine10 in 1 BOXCREAM106
47682-270-73Medi-First Burn with Lidocaine0.9 g in 1 PACKETCREAM0.96
47682-270-73Medi-First Burn with Lidocaine25 in 1 BOXCREAM256
47682-270-99Medi-First Burn with Lidocaine0.9 g in 1 PACKETCREAM0.96

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-270MEDI-FIRST PLUS BURN WITH LIDOCAINE (BENZALKONIUM CHLORIDE, LIDOCAINE) CREAM MEDI-FIRST BURN WITH LIDOCAINE (BENZALKONIUM CHLORIDE, LIDOCAINE) CREAM [UNIFIRST FIRST AID CORPORATION]6Current NDC, Legacy NDC, 5 package rows20240118_bd46efc8-0b36-0931-e053-2a95a90adb6f.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 114 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Henry Schein Povidone-Iodine SwabsticksPOVIDONE-IODINEHenry Schein, Inc.5854f241-6cfc-4e5a-ba72-92dd0703f7282023-10-13WarningsExact identifier
application number: M003
DawnMist Alcohol Hand SanitizerALCOHOLDukal LLCa2df96a9-8514-6839-e053-2a95a90a94172023-10-13WarningsExact identifier
application number: M003
DUKAL STING RELIEF PADBENZOCAINEDukal LLC67c1ddc7-8fde-4431-84cb-f757682d5f3e2023-10-13WarningsExact identifier
application number: M003
First Aid Only First Aid/BurnLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDEAcme United Corporation07245b54-b193-178e-e063-6394a90a25812023-10-09WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk originalETHYL ALCOHOLRejoice International Corp.06dc1730-216a-8b4d-e063-6294a90a41842023-10-04WarningsExact identifier
application number: M003
Hand sanitizer 1.8oz with extra clip originalETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.06dcf8dc-0831-475e-e063-6394a90a9fef2023-10-04WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk originalETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.06dd2427-097c-b0fa-e063-6294a90a4f822023-10-04WarningsExact identifier
application number: M003
Hand sanitizer 1.8oz with extra clip originalETHYL ALCOHOLRejoice International Corp.06da0cc1-95f2-4f88-e063-6394a90a25ea2023-10-03WarningsExact identifier
application number: M003
First Aid Antiseptic Alcohol Pads Isopropyl Alcohol 70 Rite AidISOPROPYL ALCOHOLRite Aid Corporationaa0df5fe-62d1-407d-b8f9-a7fd9473d5692023-10-02WarningsExact identifier
application number: M003
Foaming Instant Hand Sanitizer with AloeETHANOLMCKESSON MEDICAL-SURGICAL INC.5c1f69b7-c8d8-477c-b614-47a3287b0e4c2023-06-05WarningsExact identifier
application number: M003
Bactine Max DryLIDOCAINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation466404cd-c46a-4944-b1ac-3b3b17f436a12022-12-27WarningsExact identifier
application number: M003
Povidone-Iodine PadPOVIDONE-IODINEShandong Haiyan Medical Manufacture Co., Ltd.c9187a07-92d5-15ac-e053-2995a90af4cb2022-03-19WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLShandong Haiyan Medical Manufacture Co., Ltd.1a117840-22d0-4a88-b1a6-e43162a444ab2022-03-19WarningsExact identifier
application number: M003
FIRSTAR BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.28591a97-9291-48c8-a8e3-c419180331b32021-07-06WarningsExact identifier
application number: M003
Bactine MaxBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation28e8a311-20a4-45a1-8d5d-ca42b101c2752021-02-24WarningsExact identifier
application number: M003
Hand Sanitizer Lemon 2ozALCOHOLNingbo Rejoice Internationalb0a4159a-cb07-4ce6-e053-2995a90a76e72020-10-02WarningsExact identifier
application number: M003
Sanix Alcohol Hand RubALCOHOLTopiderm, Inca4fbb714-4f20-400a-ab98-f1c8807ce6fc2020-03-24WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSNbd46efc8-0b36-0931-e053-2a95a90adb6f6
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCDbd46efc8-0b36-0931-e053-2a95a90adb6f6
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSYbd46efc8-0b36-0931-e053-2a95a90adb6f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-270-124768202701210 PACKET in 1 BOX (47682-270-12) / .9 g in 1 PACKET10 packet2021-06-012028-04-30NoNoCurrent
47682-270-734768202707325 PACKET in 1 BOX (47682-270-73) / .9 g in 1 PACKET25 packet2021-06-012028-04-30NoNoCurrent
47682-270-9947682027099.9 g in 1 PACKET (47682-270-99) 2021-06-012028-04-30NoNoCurrent