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: 2026-12-31
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: 2026-12-31

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 64 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dragon Pain Relieving Balm	CAMPHOR, MENTHOL	Americanna Wellness, Inc.	154fd46e-f00d-1772-e063-6394a90aba7d	2025-11-12	Warnings	Exact identifier application number: M017
Best Choice Itch Stopping	DIPHENHYDRAMINE HCL	Valu Merchandisers	884cfd64-2cd1-8c12-e053-2995a90a8925	2025-11-12	Warnings	Exact identifier application number: M017
Itch Stopping	DIPHENHYDRAMINE HCL	CVS	8839149d-e6d5-57cc-e053-2995a90a9832	2025-11-12	Warnings	Exact identifier application number: M017
Itch Stopping	DIPHENHYDRAMINE HCL	Chain Drug Marketing Association	884c9b47-d511-1d17-e053-2995a90a42eb	2025-11-12	Warnings	Exact identifier application number: M017
Painless Tattoo 1	BENZOCAINE	Sambria Pharmaceuticals, LLC	2f8fdcac-b87a-4191-9504-480a473f95cc	2025-11-12	Warnings	Exact identifier application number: M017
Painless Tattoo 2	LIDOCAINE	Sambria Pharmaceuticals, LLC	180b2899-7699-40e2-974a-081a6ce2bca2	2025-11-12	Warnings	Exact identifier application number: M017
Painless Tattoo 3	TETRACAINE	Sambria Pharmaceuticals, LLC	9c24dcff-3988-40eb-821a-fd4b0c85f528	2025-11-12	Warnings	Exact identifier application number: M017
Tattoo Numbing Cream Co	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	2a64b3ef-ed2d-49db-996d-f63ffecb5a1e	2025-11-12	Warnings	Exact identifier application number: M017
Painless Tattoo Numbing	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	efd3289f-dfb2-487c-a76f-00fe8af414e3	2025-11-12	Warnings	Exact identifier application number: M017
Now Numb Numbing Cream	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	fed833f5-4f76-46e8-8ae1-655a9e576f70	2025-11-12	Warnings	Exact identifier application number: M017
Painless Tattoo Numbing Cream	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	852504ec-d4fa-4cae-ba89-7ffb57df8efe	2025-11-12	Warnings	Exact identifier application number: M017
Arte Maximum strength Numbing Cream	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	e612a256-3f44-46db-bb6a-e550c2216fdc	2025-11-12	Warnings	Exact identifier application number: M017
Hello Sugar	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	5f30254d-a28f-443d-8729-5c5dde4a0217	2025-11-12	Warnings	Exact identifier application number: M017
YULAM DIE DA WAN HUA PAIN RELIEVING	MENTHOL AND CAMPHOR	MADISON ONE ACME INC	1ba3c31b-2737-4b55-a0ea-90013a1d8cf4	2025-11-12	Warnings, Adverse reactions	Exact identifier application number: M017
TattooNumb	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	d9c4d664-54de-40c2-8836-72b60e6d9ac0	2025-11-12	Warnings	Exact identifier application number: M017
BeardedMoney	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	35ff688b-75c5-4780-b294-192af780d705	2025-11-12	Warnings	Exact identifier application number: M017
NeuroMed 7 Topical Pain Relief	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	f199f56b-d971-4cf8-834d-babb5c2ff81a	2025-11-12	Warnings	Exact identifier application number: M017
NeuroMed Topical Anesthetic 7	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals	8a2b6b76-6bcc-4f52-b037-e6cbc74f8377	2025-11-12	Warnings	Exact identifier application number: M017
NeuroMed Topical Anesthetic 7	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals	67b25c37-db32-4980-88b0-b07712345939	2025-11-12	Warnings	Exact identifier application number: M017
NeuroMed Topical Analgesic LA	TETRACAINE HCL	Sambria Pharmaceuticals, Inc.	3c1e3a1d-f42b-499d-a445-1d1d3dd26c19	2025-11-12	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