FDA.reportPublic FDA data

SunBurnt PLUS

Product NDC
68229-600
11-digit product format
682290600
Labeler code
68229
Product ID
68229-600_4b23ad3d-3c31-6124-e063-6394a90a54f7
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
GEL
Route
TOPICAL
Labeler
Quest Products, LLC.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-01
Marketing end
2026-07-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SunBurnt PLUS

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE4 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1010077

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68229-600-01SunBurnt PLUS1 in 1 CARTONGEL15
68229-600-02SunBurnt PLUS118.294 mL in 1 TUBEGEL118.2945

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68229-600SUNBURNT PLUS (LIDOCAINE HYDROCHLORIDE) GEL [QUEST PRODUCTS, LLC.]4Current NDC, Legacy NDC, 2 package rows20241107_12de2559-05b0-4580-84c1-d3bd010b1c99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010077lidocaine HCl 4 % Topical GelPSN12de2559-05b0-4580-84c1-d3bd010b1c995
1010077lidocaine hydrochloride 0.04 MG/MG Topical GelSCD12de2559-05b0-4580-84c1-d3bd010b1c995
1010077lidocaine hydrochloride 4 % Topical GelSY12de2559-05b0-4580-84c1-d3bd010b1c995

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68229-600-01682290600011 TUBE in 1 CARTON (68229-600-01) / 118.294 mL in 1 TUBE (68229-600-02) 1 tube2020-07-012026-07-31NoNoCurrent
68229-600-0268229060002118.294 mL in 1 TUBE118.294 mlHistorical