Hielo Ardiente

Product NDC: 53145-002
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 · 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	Code	Status	Snapshot	Source SHA-256
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53145-002-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53145-002-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53145-002-01	E	Excluded after deficient or non-compliant submission was not corrected	`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 116 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Signature Care Menthol	MENTHOL 4%	Safeway	27d3cb47-a6c7-5b7a-e063-6394a90a056f	2024-12-05	Warnings	Exact identifier application number: M017
ITCH X	BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE	BF ASCHER AND CO INC	03c16d33-8f59-0184-e054-00144ff8d46c	2024-12-05	Warnings	Exact identifier application number: M017
PO First Aid Series BURN	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	f1c349a8-216d-4233-922e-c95329a33d1e	2024-12-05	Warnings	Exact identifier application number: M017
Post Treatment Balm	HYDROCORTISONE	Allure Labs Inc.	faa803e6-453c-4d86-85dd-5a5dcdd72d02	2024-12-05	Warnings	Exact identifier application number: M017
CBD Pain Relief Cream	TROLAMINE SALICYLATE	Allure Labs	b6b3102a-4154-2da2-e053-2995a90ae99f	2024-12-05	Warnings	Exact identifier application number: M017
CVS Health Pain Relieving	CAMPHOR (SYNTHETIC), MENTHOL (UNSPECIFIED FORM), METHYL SALICYLATE	Natural Essentials, Inc.	f7198485-3d68-41d2-b9b9-f932a0649310	2024-12-04	Warnings	Exact identifier application number: M017
Salonpas LIDOCAINE PLUS	BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE	Hisamitsu America, Inc.	364924d3-fac3-4f4e-9b40-decd4ec48245	2024-12-03	Warnings	Exact identifier application number: M017
Bite and Itch	DIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE	Weeks & Leo Co., Inc.	0a4d471b-c3f3-0a6a-e063-6394a90ad57b	2024-12-03	Warnings	Exact identifier application number: M017
Menthol	AMISH ORIGINS MEDICATED	Amish Origins LLC	547abe39-3af3-4d70-99dd-caf8d67feda2	2024-12-03	Warnings	Exact identifier application number: M017
Meijer Small Cold-Hot Medicated Patches	MENTHOL	Meijer Distribution Inc	be6012d6-2062-45ba-8fc4-abf14cff5845	2024-12-03	Warnings	Exact identifier application number: M017
Salonpas	CAMPHOR, MENTHOL, METHYL SALICYLATE	Hisamitsu Pharmaceutical Co., Inc.	acdd5622-a9a7-4cc3-877e-57efea23303f	2024-12-03	Warnings	Exact identifier application number: M017
Salonpas	CAMPHOR, MENTHOL, METHYL SALICYLATE	Hisamitsu Pharmaceutical Co., Inc.	5bb6c6a3-7dc0-463d-ab2c-9f3bd3f3eff5	2024-12-03	Warnings	Exact identifier application number: M017
Salonpas DEEP Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	Hisamitsu America, Inc.	a4ddb2b9-d023-4c8c-9285-93d51f93207d	2024-12-03	Warnings	Exact identifier application number: M017
Salonpas LIDOCAINE PLUS	BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE	Hisamitsu America, Inc.	ea5b4a7f-d47d-4dbd-9288-c01329e387e5	2024-12-03	Warnings	Exact identifier application number: M017
Hempvana Ultra Strength Pain Relief - Overnight	LIDOCAINE	Telebrands Corp	1030d478-6805-6579-e063-6294a90a0c76	2024-12-02	Warnings	Exact identifier application number: M017
Campho-Phenique Cold Sore Treatment	CAMPHOR (SYNTHETIC) AND PHENOL	Foundation Consumer Healthcare LLC	106c0bb2-f2e2-4255-867d-d09ff6a5a2e6	2024-12-02	Warnings	Exact identifier application number: M017
Campho-Phenique Antiseptic	CAMPHOR (SYNTHETIC) AND PHENOL	Foundation Consumer Healthcare LLC	82edaef0-0709-4ae1-a664-c9c5adb91ee1	2024-12-02	Warnings	Exact identifier application number: M017
Thermacare Arthritis and Nerve Pain Therapy Capsaicin Roll On	THERMACARE CAPSAICIN ROLL ON	Clarion Brands LLC	2850f7e7-41dd-f5f9-e063-6394a90ae519	2024-12-02	Warnings	Exact identifier application number: M017
BURN	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	NINGBO TIANBO FIRST AID PRODUCT CO., LTD.	2ec1cf79-c341-4b79-9047-ce29f0dff419	2024-11-29	Warnings	Exact identifier application number: M017
TheraCare Pain Relieving Lidocaine Cream	LIDOCAINE HYDROCHLORIDE	Veridian Healthcare	242204d3-efc7-f7a9-e063-6294a90a5af1	2024-11-27	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