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 74 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nufabrx Medicine Infused Socks	CAPSAICIN	Nufabrx LLC	00d7d5bf-ee03-e73d-e063-6394a90a5d94	2025-10-15	Warnings	Exact identifier application number: M017
Nufabrx Medicine Infused Elbow Sleeve	CAPSAICIN	Nufabrx LLC	27ef3ef0-2f98-6672-e063-6294a90aeca4	2025-10-15	Warnings	Exact identifier application number: M017
Nufabrx Medicine Infused Wrist Sleeve	CAPSAICIN	Nufabrx LLC	22572cf9-fc0c-d327-e063-6394a90a2186	2025-10-15	Warnings	Exact identifier application number: M017
Antibacterial Lidocaine Wound Gel	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	WALGREENS	eff77965-dc7f-49af-e053-2995a90a1a97	2025-10-14	Warnings	Exact identifier application number: M017
Pleasure Balm Kama Sutra	BENZOCAINE	Cosmetic Enterprises Ltd	f370e3c4-65ca-4f3c-a5aa-70e198e681a2	2025-10-14	Warnings	Exact identifier application number: M017
Vanicream HC Anti-Itch	HYDROCORTISONE	Pharmaceutical Specialties, Inc.	28b06507-27a5-2cb1-e054-00144ff8d46c	2025-10-14	Warnings	Exact identifier application number: M017
Trilogel	LIDOCAINE HYDROCHLORIDE	Trifluent Pharma LLC	22af7d63-6a56-4a38-a95b-0f88410b23cb	2025-10-14	Warnings	Exact identifier application number: M017
PROINNATE Numbing Cream	MENTHOL	Guangzhou Haishi Biological Technology Co., Ltd.	40c63645-8ed3-82b3-e063-6294a90a5267	2025-10-13	Warnings	Exact identifier application number: M017
Cramergesic	MENTHOL, METHYL SALICYLATE	The Hygenic Company, LLC	d0ffde7a-6942-74fc-e053-2a95a90a484a	2025-10-13	Warnings	Exact identifier application number: M017
Tricylate	MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE	Trifluent Pharma LLC	4869b63a-e01e-4a79-a493-7a1b4d3e914b	2025-10-13	Warnings	Exact identifier application number: M017
Doloflex Pain Relief	MENTHOL, METHYL SALICYLATE	United Health & Beauty Corp	32a830cc-04d3-102e-e063-6294a90a1cad	2025-10-12	Warnings	Exact identifier application number: M017
Lidocaine Pain Relieving Gel-Patch	LIDOCAINE	Nanjing Anxing Medical Technology Co., Ltd.	40c9b132-57ce-865e-e063-6394a90a2080	2025-10-10	Warnings	Exact identifier application number: M017
Kinesys	ZINC OXIDE	Wilc Healthcare Inc	a32b44c3-eda0-48ea-95fc-250a2c2396ca	2025-10-10	Warnings	Exact identifier application number: M017
Te-Fu Recovery Massage	MENTHOL, METHYL SALICYLATE	Wasatch Product Development	7bc2989f-dfb6-e8af-e053-2991aa0a0bf2	2025-10-10	Warnings	Exact identifier application number: M017
Anti-itch	HYDROCORTISONE	Medline Industries, LP	b0947381-c0db-4253-ab40-3d45603ae65d	2025-10-09	Warnings	Exact identifier application number: M017
Kalaya Pain Relief	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	e2452c4b-2548-497f-828b-5d960402522a	2025-10-08	Warnings	Exact identifier application number: M017
Kalaya Pain Relief 6X with Arnica	PAIN RELIEF CREAM	Avaria Health & Beauty Corp	60198d2e-4de3-3fa0-e053-2a91aa0afaf7	2025-10-08	Warnings	Exact identifier application number: M017
KALAYA PAIN RELIEF 6X WITH ARNICA - Pain Relief	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	9b9b7cad-a5e2-4445-856b-4aa439d77a80	2025-10-08	Warnings	Exact identifier application number: M017
KALAYA FOAMING PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	d5021e6d-f29f-446b-874c-bdcabd9cf4f6	2025-10-08	Warnings	Exact identifier application number: M017
KALAYA EXTRA STRENGTH FOAMING PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	e0c9f22a-165a-4558-ba3c-8592f1bd0016	2025-10-08	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