Hielo Ardiente

Product NDC: 53145-002
Requested package NDC: 53145-002-01
11-digit product format: 531450002
Labeler code: 53145
Product ID: 53145-002_3a876b4d-bba4-c8d4-e063-6394a90abaa0
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: GEL
Route: TOPICAL
Labeler: Menper Distributors, Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-02-21
Substance: MENTHOL
Active strength: 1 g/100g
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 · 3 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	Archive	Snapshot	Source SHA-256
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53145-002	53145-002-01	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53145-002	53145-002-01	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53145-002	53145-002-01	E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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: Hielo Ardiente
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1039043	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
97ec516c-d2bc-47ce-82fe-bd68445d9570	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53145-002-01	2023-07-28	C162847	48780-1	9d75b9d1-0744-f424-e053-dadaa90a57ce	Hielo Ardiente
53145-002-01	2021-04-21	C162847	48780-1	9d75b9d1-0744-f424-e053-dadaa90a57ce	Hielo Ardiente
53145-002-01	2020-01-31	C162847	48780-1	9d75b9d1-0744-f424-e053-dadaa90a57ce	Hielo Ardiente

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53145-002-01	Hielo Ardiente	454 g in 1 JAR	GEL	454		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	HIELO ARDIENTE (MENTHOL) GEL [MENPER DISTRIBUTORS, INC.]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	HIELO ARDIENTE (MENTHOL) GEL [MENPER DISTRIBUTORS, INC.]	1
CAMPHOR (SYNTHETIC)	INACTIVE INGREDIENT	5TJD82A1ET	HIELO ARDIENTE (MENTHOL) GEL [MENPER DISTRIBUTORS, INC.]	1
CARBOMER 940	INACTIVE INGREDIENT	4Q93RCW27E	HIELO ARDIENTE (MENTHOL) GEL [MENPER DISTRIBUTORS, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HIELO ARDIENTE (MENTHOL) GEL [MENPER DISTRIBUTORS, INC.]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	HIELO ARDIENTE (MENTHOL) GEL [MENPER DISTRIBUTORS, INC.]	1
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	HIELO ARDIENTE (MENTHOL) GEL [MENPER DISTRIBUTORS, INC.]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	HIELO ARDIENTE (MENTHOL) GEL [MENPER DISTRIBUTORS, INC.]	1
TRIETHANOLAMINE BENZOATE	INACTIVE INGREDIENT	M3EN4GC19W	HIELO ARDIENTE (MENTHOL) GEL [MENPER DISTRIBUTORS, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HIELO ARDIENTE (MENTHOL) GEL [MENPER DISTRIBUTORS, INC.]	1

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 55 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Joint and Muscle Relief	MENTHOL	Smart Cookie Solutions Inc.	45c24d56-4dc9-2884-e063-6294a90a52cc	2025-12-12	Warnings	Exact identifier application number: M017
Popstar	DELAY SPRAY	Pineapple Brands LLC	293b2da9-1261-0358-e063-6394a90aa08c	2025-12-12	Warnings	Exact identifier application number: M017
Careland Pain Relief Plus	CAMPHOR, MENTHOL, METHYL SALICYLATE	Planet (Anhui) Pharmaceutical Co., Ltd.	d9e63ddd-d003-45fa-b156-7f4452c28cbd	2025-12-12	Warnings	Exact identifier application number: M017
Glucosamine Cream EXTRA STRENGTH	HISTAMINE DIHYDROCHLORIDE	IDEAZ, LLC	f4d414b7-89e7-ad65-e053-2a95a90a25d4	2025-12-12	Warnings	Exact identifier application number: M017
ARTHRITIS	MENTHOL	Smith Amish, LLC	20c36972-b695-1241-e063-6394a90adf63	2025-12-12	Warnings	Exact identifier application number: M017
FOOT	MENTHOL	Smith Amish, LLC	20c48537-f55f-c10f-e063-6394a90a4cca	2025-12-12	Warnings	Exact identifier application number: M017
Joint Ease	MENTHOL	Smith Amish, LLC	20c4a0f8-bdc6-d89a-e063-6294a90aa8d8	2025-12-12	Warnings	Exact identifier application number: M017
Toast Screamin Hot	CAPSAICIN	IDEAZ, LLC	331207e6-b8ac-b169-e063-6394a90ac169	2025-12-12	Warnings	Exact identifier application number: M017
Pain Relief Gel-Patch	LIDOCAINE	KORVIA GLOBAL Inc.	45ccfcae-a307-1c5f-e063-6294a90acf89	2025-12-12	Warnings	Exact identifier application number: M017
Lidospot patch	LIDOCAINE AND MENTHOL	Fabrication Enterprises Inc	3a6e94c4-1ca6-e77a-e063-6394a90a4bfc	2025-12-12	Warnings	Exact identifier application number: M017
LETEBEE LIGHT neuropathy pain relief cream for feet	MENTHOL	Guangdong Aimu Biological Technology Co., Ltd	45a99afc-15ec-76c2-e063-6294a90a2220	2025-12-11	Warnings	Exact identifier application number: M017
Cinthera	LIDOCAINE	Strand Health Group	2746e5b2-be2d-f2d2-e063-6394a90a3690	2025-12-11	Warnings	Exact identifier application number: M017
Equate Cool and Heat Pain Relieving Liquid	COOL AND HEAT PAIN RELIEF	Walmart, Inc.	ad156685-3bd5-6837-e053-2995a90ac788	2025-12-11	Warnings	Exact identifier application number: M017
HUMCO Camphor Spirit	CAMPHOR 10%	Humco Holding Group, Inc.	9a0ef0a3-3c79-41b2-8193-424a3ef9886f	2025-12-11	Warnings	Exact identifier application number: M017
T-Relief Lidocaine HCL 4%	LIDOCAINE HCL 4%	Medinatura New Mexico Inc.	3c19aff8-fb18-78d0-e063-6294a90a9481	2025-12-11	Warnings	Exact identifier application number: M017
Jointiva	TROLAMINE SALICYLATE 10%	Rising Pharma Holdings, Inc.	3ee33cbf-7c0f-4982-b0b6-eeeb0202803b	2025-12-11	Warnings	Exact identifier application number: M017
LMX4	LIDOCAINE	Ferndale Laboratories, Inc.	f0e7c92f-8b0b-4045-b659-af9f6e81260f	2025-12-10	Warnings	Exact identifier application number: M017
HurriCaine One	TOPICAL ANESTHETIC AND ANTISEPTIC	Beutlich Pharmaceuticals LLC	459cedbd-9b6f-e450-e063-6394a90afb73	2025-12-10	Warnings	Exact identifier application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 3	NICOTINE TRANSDERMAL PATCHES	PCHEERY LLC	45811e83-8d0b-bc2a-e063-6294a90adf50	2025-12-09	Warnings	Exact identifier application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 2	NICOTINE TRANSDERMAL PATCHES	PCHEERY LLC	4580d7f0-92a9-d0d0-e063-6394a90ac393	2025-12-09	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1039043	menthol 1 % Topical Gel	PSN	97ec516c-d2bc-47ce-82fe-bd68445d9570	4
1039043	menthol 0.01 MG/MG Topical Gel	SCD	97ec516c-d2bc-47ce-82fe-bd68445d9570	4
1039043	menthol 1 % Topical Gel	SY	97ec516c-d2bc-47ce-82fe-bd68445d9570	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53145-002-01	53145000201	454 g in 1 JAR (53145-002-01)	454 g	2012-02-21	0000-00-00	No	No	Current