Burn

Product NDC
82942-1001
11-digit product format
829421001
Labeler code
82942
Product ID
82942-1001_369d70f9-9b65-e8f2-e063-6294a90a6b86
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
GEL
Route
TOPICAL
Labeler
J&A Digital Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-01
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
20 mg/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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE20 mg/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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82942-1001-12024-03-13C16284748780-11030e365-236b-111a-e063-dadaa90a10e2Burn
82942-1001-12024-01-30C16284748780-11030e365-236b-111a-e063-dadaa90a10e2Burn

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82942-1001-1Burn0.9 g in 1 PACKETGEL0.93

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82942-1001BURN (LIDOCAINE HYDROCHLORIDE) GEL [J&A DIGITAL INC.]2Current NDC, Legacy NDC, 1 package rows20240315_d4b09055-b93e-466f-9e24-cae098af6e24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011852lidocaine HCl 2 % Topical GelPSNd4b09055-b93e-466f-9e24-cae098af6e243
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCDd4b09055-b93e-466f-9e24-cae098af6e243
1011852lidocaine hydrochloride 2 % Topical JellySYd4b09055-b93e-466f-9e24-cae098af6e243

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82942-1001-182942100101.9 g in 1 PACKET (82942-1001-1) 2022-10-010000-00-00NoNoCurrent