Burn Gel

Product NDC
69396-106
11-digit product format
693960106
Labeler code
69396
Product ID
69396-106_1d0c584e-df78-3af3-e063-6394a90ac8a1
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine HCI
Dosage form
GEL
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals USA LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-09-27
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
.02 g/g
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 Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE.02 g/g

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
69396-106-09Burn Gel0.9 g in 1 PACKETGEL0.93
69396-106-09Burn Gel144 in 1 CARTONGEL1443

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69396-106-09EA - Each69396-106e1d05818-54e5-4c45-8396-912ab764dc2312024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-106BURN GEL (LIDOCAINE HCI) GEL [TRIFECTA PHARMACEUTICALS USA LLC]3Current NDC, Legacy NDC, 2 package rows20240713_e9d3e9be-1036-fad0-e053-2a95a90a6efe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011852lidocaine HCl 2 % Topical GelPSNe9d3e9be-1036-fad0-e053-2a95a90a6efe3
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCDe9d3e9be-1036-fad0-e053-2a95a90a6efe3
1011852lidocaine hydrochloride 2 % Topical JellySYe9d3e9be-1036-fad0-e053-2a95a90a6efe3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69396-106-0969396010609144 PACKET in 1 CARTON (69396-106-09) / .9 g in 1 PACKET144 packet2022-09-270000-00-00NoNoCurrent