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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
56866fa8-052e-497c-a954-978d7d628949	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
61477-101-11	2024-02-13	ALOE UP - ALOE ICE SUNBURN RELIEF JELLY (61477-101)
61477-101-14	2024-02-13	ALOE UP - ALOE ICE SUNBURN RELIEF JELLY (61477-101)
61477-101-11	2024-01-30	ALOE UP - ALOE ICE SUNBURN RELIEF JELLY (61477-101)
61477-101-14	2024-01-30	ALOE UP - ALOE ICE SUNBURN RELIEF JELLY (61477-101)
61477-101-11	2022-04-14	ALOE UP - ALOE ICE SUNBURN RELIEF JELLY (61477-101)
61477-101-14	2022-04-14	ALOE UP - ALOE ICE SUNBURN RELIEF JELLY (61477-101)
61477-101-11	2022-01-28	ALOE UP - ALOE ICE SUNBURN RELIEF JELLY (61477-101)
61477-101-14	2022-01-28	ALOE UP - ALOE ICE SUNBURN RELIEF JELLY (61477-101)

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
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 28 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LIDOGUARD	LIDOCAINE 4%	ViolaCare, Inc.	d8b021b6-cf71-4f7e-9d27-92d0982bd34f	2026-03-25	Warnings	Exact identifier application number: M017
LactiGo	MENTHOL	LactiGo, Inc.	4dda6ac4-d849-69a6-e063-6394a90a3c54	2026-03-25	Warnings	Exact identifier application number: M017
Alocane Max	LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE	Quest Products LLC	0a33f9a9-1fdc-7cdf-e063-6294a90adca1	2026-03-25	Warnings	Exact identifier application number: M017
EjaGuard	LIDOCAINE	MOLANSPACE INC	475f64ef-d636-7e87-e063-6294a90ae32f	2026-03-25	Warnings	Exact identifier application number: M017
Hydrocortisone 1%	HYDROCORTISONE	ProStat First Aid	4e53d29c-ed3c-f481-e063-6294a90a3181	2026-03-25	Warnings	Exact identifier application number: M017
Topicaine Ultra	TOPICAINE ULTRA	Oncora Pharma, LLC	e052f718-700a-44e0-8770-65451b812ee1	2026-03-24	Warnings	Exact identifier application number: M017
Hot Pap Cataplasma	METHYL SALICYLATE, VANILLYL NONYLAMIDE	Masaem Company	4dbeda13-b198-0cf0-e063-6294a90a8180	2026-03-24	Warnings	Exact identifier application number: M017
Barmicil Anti-itch	HYDROCORTISONE	OPMX LLC	850084c3-1dd4-eb8d-e053-2a91aa0a130b	2026-03-24	Warnings	Exact identifier application number: M017
Jeil Hangbang Paff Soo S Cataplasma	GLYCOL SALICYLATE, L-MENTHOL	Masaem Company	4dd040db-07cf-361a-e063-6394a90a8001	2026-03-24	Warnings	Exact identifier application number: M017
Zenol Double Action	METHYL SALICYLATE, L-MENTHOL	BA TRADE INC	4da998fc-75a3-583f-e063-6394a90a59c7	2026-03-23	Warnings	Exact identifier application number: M017
Ultra Strength Topical Pain Relief Cream	CAMPHOR, MENTHOL, METHYL SALICYLATE	J C UDEOZOR & SONS GLOBAL INDUSTRIES LTD	4db9ae57-4ab4-8fe4-e063-6394a90a7e51	2026-03-23	Warnings	Exact identifier application number: M017
DR. SANA ALIVIO TOTAL ALIVIO TOTAL ROLL ON	ALIVIO TOTAL ROLL ON	EVI LABS	4da01338-8739-08a8-e063-6294a90ae157	2026-03-22	Warnings	Exact identifier application number: M017
DR SANA ALIVIO TOTAL ALIVIO TOTAL	ALIVIO TOTAL	EVI LABS	4da1c3b8-9af2-6e9f-e063-6394a90a86ae	2026-03-22	Warnings	Exact identifier application number: M017
SORE NO MORE	MENTHOL CAMPHOR	SOMBRA COSMETICS INC.	80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd	2026-03-20	Warnings	Exact identifier application number: M017
CVS Health Antiseptic Wound Wash	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	CVS Pharmacy	53ac017a-eccb-3b24-e054-00144ff88e88	2026-03-20	Warnings	Exact identifier application number: M017
Tecnu Diphenhydramine HCl Pain Relieving Anti Itch Gel 2%	ANTI ITCH GEL	Walgreens	3d6e8c62-2fcc-51c2-e063-6394a90a33f7	2026-03-20	Warnings	Exact identifier application number: M017
ANIXIKE Numbing	MENTHOL 5% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4d5c52d7-8e81-b62f-e063-6394a90ad03e	2026-03-19	Warnings	Exact identifier application number: M017
SYLVIRENE NUMBING	MENTHOL 5% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4d47e8c7-d293-bf63-e063-6294a90a5fd9	2026-03-18	Warnings	Exact identifier application number: M017
Antibiotic and Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	f7aa9330-c47c-4d2f-b784-11b831d919d6	2026-03-18	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Bryant Ranch Prepack	99726aa3-3b45-4175-8471-279419af5457	2026-03-18	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1011852	lidocaine HCl 2 % Topical Gel	PSN	56866fa8-052e-497c-a954-978d7d628949	11
1011852	lidocaine hydrochloride 0.02 MG/MG Topical Gel	SCD	56866fa8-052e-497c-a954-978d7d628949	11
1011852	lidocaine hydrochloride 2 % Topical Jelly	SY	56866fa8-052e-497c-a954-978d7d628949	11

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ALOE UP - ALOE ICE SUNBURN RELIEF JELLY (61477-101)	Aloe Care International, LLC	2026-01-28	HUMAN OTC DRUG LABEL	11