ALOE ICE SUNBURN RELIEF

Product NDC: 61477-101
Requested package NDC: 61477-101-14
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61477-101	61477-101-14	I	Inactivated by FDA		excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61477-101	61477-101-14	I	Inactivated by FDA		excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`

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 1 of 154 · 3,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Jakwork Numbing Cream	NUMBING CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5911d9b0-1acb-3546-e063-6294a90adb3a	2026-08-15	Warnings	Exact identifier application number: M017
RVDU WARMING PAIN RELIEF	CAPSAICIN	QIRUI NETWORK (SHENZHEN) CO., LTD.	58eb2a86-bf25-d4b5-e063-6394a90af8c4	2026-08-13	Warnings	Exact identifier application number: M017
JJ Care First Aid Burn	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Nantong Health & Beyond Hygienic Products Inc.	c41621fb-c549-4394-a4cb-cb81ef8c98df	2026-08-13	Warnings	Exact identifier application number: M017
JJ Care	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	c88fa151-f8a8-4de2-98c9-71319bf53e36	2026-08-13	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Safetec of America, Inc.	da2b3b2c-11e0-401b-bbd2-d019271d1b3d	2026-08-13	Warnings	Exact identifier application number: M017
CVS Pain Relief Roll-On Lidocaine with Lavender	LIDOCAINE HYDROCHLORIDE	CVS Pharmacy	4aa53176-2103-b47b-e063-6394a90ac735	2026-08-12	Warnings	Exact identifier application number: M017
JUST CBD SOOTHING	MENTHOL, CAMPHOR	Just Brands LLC	5384e80f-c242-76a1-e063-6294a90aba0b	2026-08-12	Warnings	Exact identifier application number: M017
RELIBONEOintment	TOPICAL ANALGESICOINTMENT	Guangdong Jiaoyu Biotechnology Co., Ltd	58ddaaf6-18ec-8c5b-e063-6294a90a2828	2026-08-12	Warnings	Exact identifier application number: M017
Capsaicin Cream	CAPSAICIN	Trifecta Pharmaceuticals USA LLC	58de3a29-2bec-6e44-e063-6394a90a9c1a	2026-08-12	Warnings	Exact identifier application number: M017
Muscle Rub Cream	MUSCLE RUB	ALLIED TRADE LINK LLC	11d33e60-8c64-4316-a29a-d17e3e6e4a28	2026-08-11	Warnings	Exact identifier application number: M017
Dr. Scholls Blister Pain Relief Complete Kit	LIDOCAINE	Scholl's Wellness Company LLC	58c2b35c-e1ed-7ea8-e063-6294a90a1494	2026-08-11	Warnings	Exact identifier application number: M017
Arctic Ice Pain Relieving Gel	MENTHOL	ONEST LIMITED	c63ef7a5-d649-4fba-9361-d37f1150e21d	2026-08-11	Warnings	Exact identifier application number: M017
Gee Gason	MALE GENITAL DESENSITIZER	Mon Gars Boutique Inc	58c75e5c-b801-017f-e063-6394a90a1c75	2026-08-11	Warnings	Exact identifier application number: M017
Capsaicin Cream	CAPSAICIN	Trifecta Pharmaceuticals USA LLC	58c84330-15bf-c397-e063-6394a90aba05	2026-08-11	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE	TARGET Corporation	4a140b9a-0e3c-4b50-b9c0-9e72616bb7d5	2026-08-11	Warnings	Exact identifier application number: M017
Medicated BODY	MENTHOL	CVS Pharmacy, Inc.	a0f61498-69c8-4ce0-bbd7-3a807f192d36	2026-08-11	Warnings	Exact identifier application number: M017
Muscle Move	MENTHOL	Saje Natural Wellness Inc.	526d3305-4cf8-2fc5-e063-6394a90ad53b	2026-08-10	Warnings	Exact identifier application number: M017
CVS Pain Relief	MENTHOL	CVS Pharmacy	4aa629f5-8b8f-cc67-e063-6394a90a019f	2026-08-07	Warnings	Exact identifier application number: M017
Instant Cooling Itch Relief	HYDROCORTISONE	CVS Pharmacy	46545d04-5958-d136-e063-6394a90a3462	2026-08-07	Warnings	Exact identifier application number: M017
CVS Itch Relief	PRAMOXINE HYDROCHLORIDE, ZINC ACETATE	CVS Pharmacy	46921bea-fcbe-94d6-e063-6394a90a726b	2026-08-07	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
61477-101-14	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