FDA.reportPublic FDA data

Select Brand Burn Relief

Product NDC
15127-002
11-digit product format
151270002
Labeler code
15127
Product ID
15127-002_b3b33a6e-ec28-4c64-ac57-da170dec6eb3
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE HCL
Dosage form
GEL
Route
TOPICAL
Labeler
Select Brand Distributors
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-11-19
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
1 g/100g
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
15127-002-162020-01-31C16284748780-19d75b9cf-e3c3-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15127-002-16Select Brand Burn Relief226 g in 1 BOTTLE, PLASTICGEL2261

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ASELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]1
LIDOCAINEACTIVE MOIETY98PI200987SELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4SELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MSELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ASELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKSELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]1
WATERINACTIVE INGREDIENT059QF0KO0RSELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15127-002SELECT BRAND BURN RELIEF (LIDOCAINE HCL) GEL [SELECT BRAND DISTRIBUTORS]1Legacy NDC, 1 package rows20121122_a74fd985-2b1d-4849-9a91-ee82f8dcab29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011849lidocaine HCl 0.5 % Topical GelPSNa74fd985-2b1d-4849-9a91-ee82f8dcab291
1011849lidocaine hydrochloride 0.005 MG/MG Topical GelSCDa74fd985-2b1d-4849-9a91-ee82f8dcab291
1011849lidocaine hydrochloride 0.5 % Topical GelSYa74fd985-2b1d-4849-9a91-ee82f8dcab291

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
15127-002-1615127000216226 g in 1 BOTTLE, PLASTIC226 gHistorical