FDA.reportPublic FDA data

Burn Ease

Product NDC
58228-3831
11-digit product format
582283831
Labeler code
58228
Product ID
58228-3831_46014702-dd4d-cbbb-e063-6394a90a81cb
Type
HUMAN OTC DRUG
Nonproprietary name
Burn Ease
Dosage form
GEL
Route
TOPICAL
Labeler
ProStat First Aid LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-10
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
2 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 Ease
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE2 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1011852

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
58228-3831-1Burn Ease3.5 g in 1 PACKETGEL3.53
58228-3831-1Burn Ease20 in 1 BOXGEL203
58228-3831-2Burn Ease480 in 1 CASEGEL4803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58228-3831BURN EASE GEL [PROSTAT FIRST AID LLC]2Current NDC, 3 package rows20241127_f71b98b4-22d0-0124-e053-6394a90ae4cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011852lidocaine HCl 2 % Topical GelPSNf71b98b4-22d0-0124-e053-6394a90ae4cf3
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCDf71b98b4-22d0-0124-e053-6394a90ae4cf3
1011852lidocaine hydrochloride 2 % Topical JellySYf71b98b4-22d0-0124-e053-6394a90ae4cf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58228-3831-1582283831013.5 g in 1 PACKET3.5 gHistorical
58228-3831-258228383102480 BOX in 1 CASE (58228-3831-2) / 20 PACKET in 1 BOX (58228-3831-1) / 3.5 g in 1 PACKET480 box2023-04-10NoNoHistorical