Home NDC 61477-101 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 date Dataset Scope Package NDC Snapshot Source SHA-256 2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 61477-101-11 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 61477-101-14 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 61477-101-11 bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 61477-101-14 bd6a592717d7…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 Ingredient Strength LIDOCAINE HYDROCHLORIDE 2 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1011852 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61477-101-11 ALOE ICE SUNBURN RELIEF 60 mL in 1 TUBE GEL 60 11 61477-101-14 ALOE ICE SUNBURN RELIEF 120 mL in 1 TUBE GEL 120 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LIDOCAINE HYDROCHLORIDE ACTIVE INGREDIENT V13007Z41A ALOE ICE SUNBURN RELIEF JELLY (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC] 3 LIDOCAINE ACTIVE MOIETY 98PI200987 ALOE ICE SUNBURN RELIEF JELLY (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC] 3 ALOE VERA WHOLE INACTIVE INGREDIENT KIZ4X2EHYX ALOE ICE SUNBURN RELIEF JELLY (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC] 3 CARBOMER 934 INACTIVE INGREDIENT Z135WT9208 ALOE ICE SUNBURN RELIEF JELLY (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC] 3 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K ALOE ICE SUNBURN RELIEF JELLY (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ALOE ICE SUNBURN RELIEF JELLY (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC] 3 IODOPROPYNYL BUTYLCARBAMATE INACTIVE INGREDIENT 603P14DHEB ALOE ICE SUNBURN RELIEF JELLY (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC] 3 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA ALOE ICE SUNBURN RELIEF JELLY (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC] 3 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH ALOE ICE SUNBURN RELIEF JELLY (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ALOE ICE SUNBURN RELIEF JELLY (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC] 3 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK ALOE ICE SUNBURN RELIEF JELLY (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC] 3 WATER INACTIVE INGREDIENT 059QF0KO0R ALOE ICE SUNBURN RELIEF JELLY (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61477-101 ALOE ICE SUNBURN RELIEF (LIDOCAINE HYDROCHLORIDE) GEL [ALOE CARE INTERNATIONAL, LLC] 10 Current NDC, Legacy NDC, 2 package rows 20240214_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 98 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15 CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 3a36a241-37a9-445a-a6e0-97709a7457a8 2025-03-19 Warnings Exact identifier application number: M017 Herb Analgesic HERB ANALGESIC PASTE Changsha Maocheng Trading Co., Ltd 29373587-9eff-6ea0-e063-6394a90a23b2 2025-03-18 Warnings Exact identifier application number: M017 DEBACHERE Butt Balm After Play Care Multi Symptoms Relief BENZOCAINE, BENZALKONIUM CHLORIDE DE.BACHERE USA LLC f469b446-58a0-4be3-884f-d622b9d074f8 2025-03-17 Warnings Exact identifier application number: M017 Auvon 4% Menthol Pain Relief Gel MENTHOL SHENZHEN YUWEN E-COMMERCE CO., LTD. 2dacd6fe-7d69-bcf0-e063-6294a90a0351 2025-03-14 Warnings Exact identifier application number: M017 Eagle Medicated MENTHOL METHYL SALICYLATE Borden Company (Private) Limited 1ee49cad-84d4-42cf-aa83-c0da6f1b1b84 2025-03-14 Warnings Exact identifier application number: M017 AY BENDITO THERMOACTIVE MENTHOL, CAMPHOR AY BENDITO INTERNATIONAL, INC 304d71b6-91c8-b2b6-e063-6394a90ab669 2025-03-14 Warnings Exact identifier application number: M017 Hot/Cold Medicated Patch HOT COLD PATCH Dynarex 999881b3-287e-d975-e053-2995a90a87e3 2025-03-14 Warnings Exact identifier application number: M017 Capsaicin 0.025% CAPSAICIN 0.025% Marcella Health 3054e7fd-cab2-7f77-e063-6294a90a498d 2025-03-14 Warnings Exact identifier application number: M017 MENTHOL 5% MENTHOL 5% Marcella Health 30914c0a-fbda-5674-e063-6294a90aba5b 2025-03-14 Warnings Exact identifier application number: M017 Peppermint Soothing Patch CAMPHORIC ACID, MENTHOL, UNSPECIFIED FORM Henan Lijitang Medical Technology Co., Ltd. 30361dd4-1f3d-ac5e-e063-6294a90a23bc 2025-03-13 Warnings Exact identifier application number: M017 AVCOO Menthol Pain Relief Patch MENTHOL ADP Health Limited 3036804b-16c3-0c88-e063-6394a90a3084 2025-03-13 Warnings Exact identifier application number: M017 LIDOCAINE 4% LIDOCAINE 4% Marcella Health 303d9462-cbfb-6251-e063-6394a90a7065 2025-03-13 Warnings Exact identifier application number: M017 XeroBurn Burn Gel LIDOCAINE HYDROCHLORIDE Dynarex Corporation 58985046-ca9c-12be-e053-2991aa0abe72 2025-03-13 Warnings Exact identifier application number: M017 Post Treatment Repair Cream HYDROCORTISONE Vege Labs LLC. 302d4327-354b-a252-e063-6394a90a20b6 2025-03-12 Warnings Exact identifier application number: M017 TheraCare Pain Relief 4% Lidocaine LIDOCAINE Veridian Healthcare 2d3fc030-5d53-2acd-e063-6294a90a11ab 2025-03-11 Warnings Exact identifier application number: M017 Cold Hot Medicated Patch 5% Menthol MENTHOL Veridian Healthcare 2d413707-794c-2fa8-e063-6394a90a06bf 2025-03-11 Warnings Exact identifier application number: M017 Cold Hot Medicated Patch 5% Menthol MENTHOL Veridian Healthcare 2d04799f-946d-ac53-e063-6294a90afeb7 2025-03-11 Warnings Exact identifier application number: M017 Muscle and Joint Care LIDOCAINE Vege Labs LLC. 301966b5-b535-dc04-e063-6394a90aec17 2025-03-11 Warnings Exact identifier application number: M017 Arctic Blast Pain Releiving MENTHOL, CAMPHOR (SYNTHETIC) Nutriomo Labs Pte, Ltd d5e7d26d-4f63-4b7b-a173-fe3a794c8459 2025-03-10 Warnings Exact identifier application number: M017 Anti Itch WALGREEN Walgreens 30014ff0-2519-4031-e063-6394a90ae07b 2025-03-10 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61477-101-11 61477010111 60 mL in 1 TUBE (61477-101-11) 60 ml 2014-02-24 0000-00-00 No No Current 61477-101-14 61477010114 120 mL in 1 TUBE (61477-101-14) 120 ml 2014-02-24 0000-00-00 No No Current