FDA.reportPublic FDA data

First Aid Antiseptic Pain Relieving

Product NDC
82996-002
11-digit product format
829960002
Labeler code
82996
Product ID
82996-002_243455d6-1590-31fa-e063-6294a90ad35d
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Hubei Changjian Medical Products Co., Ltd.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-01
Marketing end
2027-04-01
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
First Aid Antiseptic Pain Relieving

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
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
9cb3759a-35d9-4f6b-94ad-fafd4bc600bdAvailable 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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82996-002-01First Aid Antiseptic Pain Relieving0.9 g in 1 POUCHCREAM0.94
82996-002-02First Aid Antiseptic Pain Relieving3.5 g in 1 POUCHCREAM3.54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82996-002FIRST AID ANTISEPTIC PAIN RELIEVING (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [HUBEI CHANGJIAN MEDICAL PRODUCTS CO., LTD.]4Current NDC, Legacy NDC, 2 package rows20241013_9cb3759a-35d9-4f6b-94ad-fafd4bc600bd.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 71 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Luxury Hand Sanitizer Whispering WoodsALCOHOLLANTERN HEALTH & BEAUTY SDN. BHD.394e4b3a-5832-9f8d-e063-6294a90ac4492025-08-15WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Botanic BlushALCOHOLLANTERN HEALTH & BEAUTY SDN. BHD.3c62434b-c2a9-bd39-e063-6294a90af8b32025-08-15WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Golden GroveALCOHOLLANTERN HEALTH & BEAUTY SDN. BHD.3c62805a-7834-8a27-e063-6394a90a67fe2025-08-15WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Citrus SuedeALCOHOLLANTERN HEALTH & BEAUTY SDN. BHD.3c62ecc5-4252-a002-e063-6394a90ace3e2025-08-15WarningsExact identifier
application number: M003
AmeriDerm Antibacterial WashPARACHLOROMETAXYLENOLSHIELD LINE LLC6e652a7d-76bb-bb2d-e053-2a91aa0aac502025-08-15WarningsExact identifier
application number: M003
AMERIWASHPARACHLOROMETAXYLENOLSHIELD LINE LLC6d5ed0f9-fb48-7855-e053-2991aa0a18a82025-08-15WarningsExact identifier
application number: M003
365 Whole Foods Market Refreshing Hand Sanitizer Bergamot RainETHYL ALCOHOLWhole Foods Market, Inc.3c6b1a51-4097-1aad-e063-6294a90aef6f2025-08-15WarningsExact identifier
application number: M003
MedPride Bath WipesBENZALKONIUM CHLORIDEShield Line LLCecf7e545-21ca-bbe0-e053-2995a90a9a552025-08-15WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Midnight MuskALCOHOLLANTERN HEALTH & BEAUTY SDN. BHD.3c5f46b4-f202-2a44-e063-6294a90ac1062025-08-14WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Meadow MirageALCOHOLLANTERN HEALTH & BEAUTY SDN. BHD.3c5f8420-9673-6f77-e063-6294a90a81e42025-08-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Coconut BreezeALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c3af609-d342-449a-e063-6294a90a0a192025-08-13WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Fresh RainALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c3bd802-56de-ebcd-e063-6294a90aca152025-08-13WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Wild RoseALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c3c78f6-e6cb-e456-e063-6394a90ac5b82025-08-13WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Champagne ToastALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c4bceac-21bc-486e-e063-6394a90a0f372025-08-13WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.3c25e093-0335-fa1d-e063-6394a90ae6842025-08-12WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.3c266de8-0551-374c-e063-6394a90ab9f42025-08-12WarningsExact identifier
application number: M003
Alcohol Free Hand SanitizerBENZALKONIUM CHLORIDEHAIAN KANGRUI TEXTILE CO., LTD.3c273544-4562-8f37-e063-6394a90ab4d32025-08-12WarningsExact identifier
application number: M003
HealthWise Lidocaine CleansingBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEVeridian Healthcare6022803a-097e-41c6-b9ee-48c8ef380d7a2025-08-12WarningsExact identifier
application number: M003
Hand Sanitizer WipesISOPROPYL ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c37f72b-623c-c8f6-e063-6294a90a971e2025-08-12WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3c236c0b-fccd-6992-e063-6294a90a37ce2025-08-11WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN9cb3759a-35d9-4f6b-94ad-fafd4bc600bd4
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD9cb3759a-35d9-4f6b-94ad-fafd4bc600bd4
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY9cb3759a-35d9-4f6b-94ad-fafd4bc600bd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82996-002-0182996000201.9 g in 1 POUCH (82996-002-01) 2022-11-012027-04-01NoNoCurrent
82996-002-02829960002023.5 g in 1 POUCH (82996-002-02) 3.5 g2022-11-012027-04-01NoNoCurrent