ALOE ICE SUNBURN RELIEF

Product NDC
61477-101
11-digit product format
614770101
Labeler code
61477
Product ID
61477-101_497adb6b-44dd-ceee-e063-6294a90a52cc
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
GEL
Route
TOPICAL
Labeler
Aloe Care International, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-02-24
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
2 g/100mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ALOE ICE SUNBURN RELIEF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE2 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1011852

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61477-101-11ALOE ICE SUNBURN RELIEF60 mL in 1 TUBEGEL6011
61477-101-14ALOE ICE SUNBURN RELIEF120 mL in 1 TUBEGEL12011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41AALOE ICE SUNBURN RELIEF JELLY (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC]3
LIDOCAINEACTIVE MOIETY98PI200987ALOE ICE SUNBURN RELIEF JELLY (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC]3
ALOE VERA WHOLEINACTIVE INGREDIENTKIZ4X2EHYXALOE ICE SUNBURN RELIEF JELLY (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC]3
CARBOMER 934INACTIVE INGREDIENTZ135WT9208ALOE ICE SUNBURN RELIEF JELLY (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KALOE ICE SUNBURN RELIEF JELLY (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDALOE ICE SUNBURN RELIEF JELLY (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC]3
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBALOE ICE SUNBURN RELIEF JELLY (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC]3
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAALOE ICE SUNBURN RELIEF JELLY (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC]3
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHALOE ICE SUNBURN RELIEF JELLY (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ALOE ICE SUNBURN RELIEF JELLY (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC]3
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKALOE ICE SUNBURN RELIEF JELLY (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RALOE ICE SUNBURN RELIEF JELLY (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61477-101ALOE ICE SUNBURN RELIEF (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC]10Current NDC, Legacy NDC, 2 package rows20240214_56866fa8-052e-497c-a954-978d7d628949.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011852lidocaine HCl 2 % Topical GelPSN56866fa8-052e-497c-a954-978d7d62894911
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD56866fa8-052e-497c-a954-978d7d62894911
1011852lidocaine hydrochloride 2 % Topical JellySY56866fa8-052e-497c-a954-978d7d62894911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61477-101-116147701011160 mL in 1 TUBE (61477-101-11) 60 ml2014-02-240000-00-00NoNoCurrent
61477-101-1461477010114120 mL in 1 TUBE (61477-101-14) 120 ml2014-02-240000-00-00NoNoCurrent