FDA.reportPublic FDA data

Alocane Emergency Burn Pads

Product NDC
68229-403
11-digit product format
682290403
Labeler code
68229
Product ID
68229-403_e0909c29-3b37-4695-e053-2a95a90a2f3b
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
SWAB
Route
TOPICAL
Labeler
Quest Products, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-02-13
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
4 g/100mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68229-403DDiscontinued by firm2026-11-10
excluded packagepackage68229-40368229-403-02DDiscontinued by firm2026-11-10
excluded packagepackage68229-40368229-403-03DDiscontinued by firm2026-11-10

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-02-03Alocane ® Emergency Burn Pads
2020-02-03Alocane ® Emergency Burn Pads
2020-01-31Alocane ® Emergency Burn Pads
2020-01-31Alocane ® Emergency Burn Pads

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68229-403-01Alocane Emergency Burn Pads3 mL in 1 POUCHSWAB37
68229-403-02Alocane Emergency Burn Pads10 in 1 BOXSWAB107
68229-403-03Alocane Emergency Burn Pads12 in 1 BOXSWAB127

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68229-403ALOCANE EMERGENCY BURN PADS (LIDOCAINE HYDROCHLORIDE) SWAB [QUEST PRODUCTS, INC.]7Legacy NDC, 3 package rows20241107_fe58bb89-7216-4121-afd3-d1438bdfbfa2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1872891ALOCANE 4 % Medicated PadPSNfe58bb89-7216-4121-afd3-d1438bdfbfa27
1872886lidocaine HCl 4 % Medicated PadPSNfe58bb89-7216-4121-afd3-d1438bdfbfa27
1872891lidocaine hydrochloride 40 MG/ML Medicated Pad [Alocane]SBDfe58bb89-7216-4121-afd3-d1438bdfbfa27
1872886lidocaine hydrochloride 40 MG/ML Medicated PadSCDfe58bb89-7216-4121-afd3-d1438bdfbfa27
1872891Alocane 4 % Medicated PadSYfe58bb89-7216-4121-afd3-d1438bdfbfa27
1872891Alocane 40 MG/ML Medicated PadSYfe58bb89-7216-4121-afd3-d1438bdfbfa27
1872886lidocaine HCl 4 % Medicated PadSYfe58bb89-7216-4121-afd3-d1438bdfbfa27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68229-403-01682290403013 mL in 1 POUCH3 mlHistorical
68229-403-026822904030210 POUCH in 1 BOX (68229-403-02) > 3 mL in 1 POUCH (68229-403-01) 10 pouch2017-02-130000-00-00NoNoCurrent
68229-403-036822904030312 POUCH in 1 BOX (68229-403-03) > 3 mL in 1 POUCH (68229-403-01) 12 pouch2017-02-130000-00-00NoNoCurrent