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 45 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DZUL - LIDO CREME	LIDOCAINE HCL, MENTHOL	Caball Sales, Inc.	063387e4-a1b1-a467-e063-6294a90a6cbd	2026-01-08	Warnings	Exact identifier application number: M017
TOPICAINE	LIDOCAINE 4%	ESBA LABORATORIES INC.	7f96e980-891e-743d-e053-2a91aa0aea5f	2026-01-08	Warnings	Exact identifier application number: M017
LUBRICAINE	LIDOCAINE 4%	ESBA LABORATORIES INC.	9d7416b1-607d-34e0-e053-2a95a90aa3c3	2026-01-08	Warnings	Exact identifier application number: M017
0.5% LIDOCAINE BURN RELIEF	LIDOCAINE HYDROCHLORIDE	Universal Distribution Center LLC	0a1aeff0-bade-457b-a0ac-099d646c0b2e	2026-01-08	Warnings	Exact identifier application number: M017
4% MENTHOL COLD THERAPY	MENTHOL	Universal Distribution Center LLC	66892993-a755-4584-b2a8-2e8d7ac70593	2026-01-08	Warnings	Exact identifier application number: M017
Private Label Antifungal Barrier Cream	2% MICONAZOLE NITRATE CREAM	Swiss-American CDMO, LLC	e74bddea-c1ac-4e4e-84bd-5a9defb85b2d	2026-01-08	Warnings	Exact identifier application number: M017
2.0% LIDOCAINE BURN	LIDOCAINE HYDROCHLORIDE	Universal Distribution Center LLC	e1911279-85f7-4053-b6da-8f4e991347a2	2026-01-08	Warnings	Exact identifier application number: M017
POMG PAIN RELIEF ROLLER	LIDOCAINE HYDROCHLORIDE, MENTHOL	POMG LLC	1fa980fb-fc0e-fdd0-e063-6394a90adc13	2026-01-07	Warnings	Exact identifier application number: M017
Artridon Glucosamine	MENTHOL, METHYL SALICYLATE	Pharmadel LLC	73572156-4cce-0669-e053-2991aa0aaecc	2026-01-07	Warnings	Exact identifier application number: M017
HealthWise Cooling Pain Relief	MENTHOL	Veridian Healthcare	6e2ad0ab-e3a8-4e3a-8f1d-2cd6351185bd	2026-01-07	Warnings	Exact identifier application number: M017
Hydrocortisone 1% Anti-Itch Cream	HYDROCORTISONE	DLC Laboratories, Inc.	16eeec2c-065d-4da0-e063-6294a90a3873	2026-01-07	Warnings	Exact identifier application number: M017
Maximum Strength Hydrocortisone	HYDROCORTISONE	DLC Laboratories, Inc	caf50f12-f35c-4e9e-8ef7-3b0c84e225ee	2026-01-07	Warnings	Exact identifier application number: M017
EARTHS CARE MUSCLE AND JOINT RUB	CAMPHOR	DLC Laboratories, Inc.	71e33e06-4dc3-4ead-a122-ff89d93a64de	2026-01-07	Warnings	Exact identifier application number: M017
Amour CBD	PAIN RELIEF CREAM	SVD Premium Products	95b45e79-b1e7-17b2-e053-2995a90a8836	2026-01-07	Warnings	Exact identifier application number: M017
Tiger Balm Active Muscle	METHYL SALICYLATE AND MENTHOL, UNSPECIFIED FORM	Haw Par Healthcare Ltd.	845a4ead-f9c0-4009-bcae-b17cd388439b	2026-01-07	Warnings	Exact identifier application number: M017
3X Medicated Toothache and Gum Gel	BENZOCAINE	Rite Aid	996f7989-17ce-5b28-e053-2995a90af8b8	2026-01-06	Warnings	Exact identifier application number: M017
QNTAMAX Muscle and Joint Pain Relieving	CAMPHOR (SYNTHETIC), MENTHOL	Qntamax LLC	6622b94c-824e-4e84-a8d8-b60bb0b866e2	2026-01-06	Warnings	Exact identifier application number: M017
Winco Muscle and Joint Pain Relief Gel 2oz	WINCO BENGAY VANISHING SCENT MUSCLE AND JOINT PAIN RELIEF	WINCO FOODS, LLC	47bedf4e-4036-cf43-e063-6394a90a91d6	2026-01-06	Warnings	Exact identifier application number: M017
Pain Relief Hot Patch	MENTHOL AND CAPSAICIN	Universal Distribution Center LLC	110bcb16-ef0b-4bc8-8877-173a0494e1ad	2026-01-06	Warnings	Exact identifier application number: M017
WOFANLI Quit Smoking Nicotine Patches	NICOTINE PATCHES	Shenzhen Paxi Trading Co., Ltd.	4582b4e9-0c24-069d-e063-6394a90a6f4b	2026-01-05	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