FDA.reportPublic FDA data

Fruit of the Earth Aloe Vera Cool Blue

Product NDC
62217-200
11-digit product format
622170200
Labeler code
62217
Product ID
62217-200_1d9eb3d8-4244-1150-e063-6294a90a8ae0
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
GEL
Route
TOPICAL
Labeler
Fruit of the Earth, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-09-10
Substance
LIDOCAINE
Active strength
10 mg/g
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

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
Fruit of the Earth Aloe Vera Cool Blue
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1012204Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1d65bc34-2bc2-4f52-a9b3-1cb08324eb79Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62217-200-20Fruit of the Earth Aloe Vera Cool Blue567 g in 1 BOTTLEGEL5674

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987FRUIT OF THE EARTH ALOE VERA COOL BLUE (LIDOCAINE HYDROCHLORIDE) GEL [FRUIT OF THE EARTH, INC.]2
LIDOCAINEACTIVE MOIETY98PI200987FRUIT OF THE EARTH ALOE VERA COOL BLUE (LIDOCAINE HYDROCHLORIDE) GEL [FRUIT OF THE EARTH, INC.]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XFRUIT OF THE EARTH ALOE VERA COOL BLUE (LIDOCAINE HYDROCHLORIDE) GEL [FRUIT OF THE EARTH, INC.]2
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27EFRUIT OF THE EARTH ALOE VERA COOL BLUE (LIDOCAINE HYDROCHLORIDE) GEL [FRUIT OF THE EARTH, INC.]2
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUFRUIT OF THE EARTH ALOE VERA COOL BLUE (LIDOCAINE HYDROCHLORIDE) GEL [FRUIT OF THE EARTH, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFRUIT OF THE EARTH ALOE VERA COOL BLUE (LIDOCAINE HYDROCHLORIDE) GEL [FRUIT OF THE EARTH, INC.]2
ISOCETETH-20INACTIVE INGREDIENTO020065R7ZFRUIT OF THE EARTH ALOE VERA COOL BLUE (LIDOCAINE HYDROCHLORIDE) GEL [FRUIT OF THE EARTH, INC.]2
MAGNESIUM NITRATEINACTIVE INGREDIENT77CBG3UN78FRUIT OF THE EARTH ALOE VERA COOL BLUE (LIDOCAINE HYDROCHLORIDE) GEL [FRUIT OF THE EARTH, INC.]2
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SABFRUIT OF THE EARTH ALOE VERA COOL BLUE (LIDOCAINE HYDROCHLORIDE) GEL [FRUIT OF THE EARTH, INC.]2
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNFRUIT OF THE EARTH ALOE VERA COOL BLUE (LIDOCAINE HYDROCHLORIDE) GEL [FRUIT OF THE EARTH, INC.]2
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAFRUIT OF THE EARTH ALOE VERA COOL BLUE (LIDOCAINE HYDROCHLORIDE) GEL [FRUIT OF THE EARTH, INC.]2
SULISOBENZONEINACTIVE INGREDIENT1W6L629B4KFRUIT OF THE EARTH ALOE VERA COOL BLUE (LIDOCAINE HYDROCHLORIDE) GEL [FRUIT OF THE EARTH, INC.]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKFRUIT OF THE EARTH ALOE VERA COOL BLUE (LIDOCAINE HYDROCHLORIDE) GEL [FRUIT OF THE EARTH, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62217-200FRUIT OF THE EARTH ALOE VERA COOL BLUE (LIDOCAINE HYDROCHLORIDE) GEL [FRUIT OF THE EARTH, INC.]4Current NDC, Legacy NDC, 1 package rows20240725_1d65bc34-2bc2-4f52-a9b3-1cb08324eb79.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 36 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CAPSAICIN HEAT PatchCAPSAICIN HEAT PATCHHenan Enokon Medical Instrument Co., Ltd.49ac2045-2c07-af9a-e063-6294a90a052a2026-01-31WarningsExact identifier
application number: M017
COLD AND HOT MEDICATED PatchCOLD AND HOT MEDICATED PATCHHenan Enokon Medical Instrument Co., Ltd.49ac6a7b-25d3-6dc4-e063-6394a90a99b62026-01-31WarningsExact identifier
application number: M017
COLD AND HOT MEDICATED PatchCOLD AND HOT MEDICATED PATCHHenan Enokon Medical Instrument Co., Ltd.49aca763-be2a-cf38-e063-6294a90a092e2026-01-31WarningsExact identifier
application number: M017
PAIN RELIEF HOT PatchPAIN RELIEF HOT PATCHHenan Enokon Medical Instrument Co., Ltd.49ad128a-0f4c-085a-e063-6294a90ac9bb2026-01-31WarningsExact identifier
application number: M017
Walgreens Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalgreen Company3557d2e9-714a-4066-aa73-ea9e3363e5742026-01-30WarningsExact identifier
application number: M017
Alveora HEMORRHOID MASTERLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID MASTERJiangxi Yudexi Pharmaceutical Co., LTD4996f96a-898e-de01-e063-6394a90a39072026-01-30WarningsExact identifier
application number: M017
Sunburn ReliefLIDOCAINE HCL 0.5%Rite Aid Corporationb67af0c7-1ae8-4494-bb0e-d7f66ebca3522026-01-30Warnings, Adverse reactionsExact identifier
application number: M017
Drs Pharmacy PAIN RELIEF MUSCLE ARITHRITISCAPSAICINOL PHARMA TECH,LLC48fdf9dc-05df-866d-e063-6294a90ae03a2026-01-30WarningsExact identifier
application number: M017
ROCKTAPE GO Kinesiology Tape and AnalgesicMENTHOL, METHYL SALICYLATEImplus Footcare, LLCb779c7d8-dbe6-472f-9282-6cced25cfd2e2026-01-29WarningsExact identifier
application number: M017
RockSauce Warming MassageMENTHOL, METHYL SALICYLATEImplus Footcare, LLCde5f7add-1f2b-438a-ac17-753ebb53e6972026-01-29WarningsExact identifier
application number: M017
RockSauce Warming Massage Roll-OnMENTHOL, METHYL SALICYLATEImplus Footcare, LLC5a2d9c3a-67fc-4c1a-b1e8-62a93880397a2026-01-29WarningsExact identifier
application number: M017
Analgesic Dr. ColladoMENTHOL, METHYL SALICYLATELaboratorios Dr. Collado, S.Ac0dad2db-7c96-49b8-a451-bf8cfa7f798b2026-01-29WarningsExact identifier
application number: M017
RockSauce Warming MassageMENTHOL, METHYL SALICYLATEImplus Footcare, LLC3121c7f7-d7e5-4ca9-9057-03edf9c94c562026-01-29WarningsExact identifier
application number: M017
Analgesic Gel Dr. Collado Menthol 4 Methyl SalicylateMENTHOL, METHYL SALICYLATELaboratorios Dr. Collado, S.A.87c22e6f-3ab0-47c3-94ea-48b3d1a95d9d2026-01-29WarningsExact identifier
application number: M017
ProCure Hydrocortisone Cream PlusHYDROCORTISONERooftop Consumer Health, Inc.fe334cae-e019-4397-8498-df3c923ae8b52026-01-29WarningsExact identifier
application number: M017
Red Oil Pain ReliefCAMPHOR (SYNTHETIC), MENTHOL, PHENOLThe Red Oil Company Inc1e36579a-72da-46ba-ac72-5960a11c08802026-01-29WarningsExact identifier
application number: M017
Extra Strength BalmCAPSICUM, MENTHOLNATURES FORMULAE HEALTH PRODUCTS LTD.498a5e2a-4de0-561c-e063-6394a90ac05c2026-01-29WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET POTENT PAIN RELIEF45c76956-db3f-3e84-e063-6394a90adce12026-01-29WarningsExact identifier
application number: M017
PAIN RELIEF PATCHESLIDOCAINEWALMART STORES INCb82cfe42-f521-4784-8c60-98481524c5ec2026-01-29WarningsExact identifier
application number: M017
Equate Pain Relief Patch Camphor/Menthol/SalicylateCAMPHOR, MENTHOL, METHYL SALICYLATEWalmart Stores Incb869848c-21e2-5ca2-e053-2995a90a86f22026-01-29WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012204lidocaine HCl 1 % Topical GelPSN1d65bc34-2bc2-4f52-a9b3-1cb08324eb794
1012204lidocaine hydrochloride 0.01 MG/MG Topical GelSCD1d65bc34-2bc2-4f52-a9b3-1cb08324eb794
1012204lidocaine hydrochloride 1 % Topical GelSY1d65bc34-2bc2-4f52-a9b3-1cb08324eb794

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62217-200-2062217020020567 g in 1 BOTTLE (62217-200-20) 567 g2014-09-100000-00-00NoNoCurrent