Burn

Product NDC
50382-020
11-digit product format
503820020
Labeler code
50382
Product ID
50382-020_ee857dfc-abc7-2bf8-e053-2a95a90acc96
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
GEL
Route
TOPICAL
Labeler
Galentic Pharma (India) Private Limited
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-09-07
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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
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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011852lidocaine HCl 2 % Topical GelPSN9af39fcd-0a57-26d0-e053-2a95a90a99a02
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD9af39fcd-0a57-26d0-e053-2a95a90a99a02
1011852lidocaine hydrochloride 2 % Topical JellySY9af39fcd-0a57-26d0-e053-2a95a90a99a02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50382-020-1150382002011144 PACKET in 1 CARTON (50382-020-11) > .9 g in 1 PACKET144 packet2018-04-010000-00-00NoNoCurrent
50382-020-12503820020126 PACKET in 1 CARTON (50382-020-12) > 3.5 g in 1 PACKET6 packet2017-09-070000-00-00NoNoCurrent
50382-020-135038200201325 PACKET in 1 CARTON (50382-020-13) > 3.5 g in 1 PACKET25 packet2017-09-070000-00-00NoNoCurrent
50382-020-14503820020141728 PACKET in 1 CARTON (50382-020-14) > 3.5 g in 1 PACKET1728 packet2017-09-070000-00-00NoNoCurrent