FDA.reportPublic FDA data

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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61477-101-1186f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61477-101-1486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61477-101-11bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61477-101-14bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1011852Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
56866fa8-052e-497c-a954-978d7d628949Available on FDA.report

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#

NDC, Effective, Related label table
NDCEffectiveRelated label
61477-101-112024-02-13ALOE UP - ALOE ICE SUNBURN RELIEF JELLY (61477-101)
61477-101-142024-02-13ALOE UP - ALOE ICE SUNBURN RELIEF JELLY (61477-101)
61477-101-112024-01-30ALOE UP - ALOE ICE SUNBURN RELIEF JELLY (61477-101)
61477-101-142024-01-30ALOE UP - ALOE ICE SUNBURN RELIEF JELLY (61477-101)
61477-101-112022-04-14ALOE UP - ALOE ICE SUNBURN RELIEF JELLY (61477-101)
61477-101-142022-04-14ALOE UP - ALOE ICE SUNBURN RELIEF JELLY (61477-101)
61477-101-112022-01-28ALOE UP - ALOE ICE SUNBURN RELIEF JELLY (61477-101)
61477-101-142022-01-28ALOE UP - ALOE ICE SUNBURN RELIEF JELLY (61477-101)

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 64 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAmericanna Wellness, Inc.154fd46e-f00d-1772-e063-6394a90aba7d2025-11-12WarningsExact identifier
application number: M017
Best Choice Itch StoppingDIPHENHYDRAMINE HCLValu Merchandisers884cfd64-2cd1-8c12-e053-2995a90a89252025-11-12WarningsExact identifier
application number: M017
Itch StoppingDIPHENHYDRAMINE HCLCVS8839149d-e6d5-57cc-e053-2995a90a98322025-11-12WarningsExact identifier
application number: M017
Itch StoppingDIPHENHYDRAMINE HCLChain Drug Marketing Association884c9b47-d511-1d17-e053-2995a90a42eb2025-11-12WarningsExact identifier
application number: M017
Painless Tattoo 1BENZOCAINESambria Pharmaceuticals, LLC2f8fdcac-b87a-4191-9504-480a473f95cc2025-11-12WarningsExact identifier
application number: M017
Painless Tattoo 2LIDOCAINESambria Pharmaceuticals, LLC180b2899-7699-40e2-974a-081a6ce2bca22025-11-12WarningsExact identifier
application number: M017
Painless Tattoo 3TETRACAINESambria Pharmaceuticals, LLC9c24dcff-3988-40eb-821a-fd4b0c85f5282025-11-12WarningsExact identifier
application number: M017
Tattoo Numbing Cream CoLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC2a64b3ef-ed2d-49db-996d-f63ffecb5a1e2025-11-12WarningsExact identifier
application number: M017
Painless Tattoo NumbingLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCefd3289f-dfb2-487c-a76f-00fe8af414e32025-11-12WarningsExact identifier
application number: M017
Now Numb Numbing CreamLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCfed833f5-4f76-46e8-8ae1-655a9e576f702025-11-12WarningsExact identifier
application number: M017
Painless Tattoo Numbing CreamLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC852504ec-d4fa-4cae-ba89-7ffb57df8efe2025-11-12WarningsExact identifier
application number: M017
Arte Maximum strength Numbing CreamLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCe612a256-3f44-46db-bb6a-e550c2216fdc2025-11-12WarningsExact identifier
application number: M017
Hello SugarLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC5f30254d-a28f-443d-8729-5c5dde4a02172025-11-12WarningsExact identifier
application number: M017
YULAM DIE DA WAN HUA PAIN RELIEVINGMENTHOL AND CAMPHORMADISON ONE ACME INC1ba3c31b-2737-4b55-a0ea-90013a1d8cf42025-11-12Warnings, Adverse reactionsExact identifier
application number: M017
TattooNumbLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCd9c4d664-54de-40c2-8836-72b60e6d9ac02025-11-12WarningsExact identifier
application number: M017
BeardedMoneyLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC35ff688b-75c5-4780-b294-192af780d7052025-11-12WarningsExact identifier
application number: M017
NeuroMed 7 Topical Pain ReliefLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLCf199f56b-d971-4cf8-834d-babb5c2ff81a2025-11-12WarningsExact identifier
application number: M017
NeuroMed Topical Anesthetic 7LIDOCAINE HYDROCHLORIDESambria Pharmaceuticals8a2b6b76-6bcc-4f52-b037-e6cbc74f83772025-11-12WarningsExact identifier
application number: M017
NeuroMed Topical Anesthetic 7LIDOCAINE HYDROCHLORIDESambria Pharmaceuticals67b25c37-db32-4980-88b0-b077123459392025-11-12WarningsExact identifier
application number: M017
NeuroMed Topical Analgesic LATETRACAINE HCLSambria Pharmaceuticals, Inc.3c1e3a1d-f42b-499d-a445-1d1d3dd26c192025-11-12WarningsExact identifier
application number: M017

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