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 65 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NeuroMed FA	BENZOCAINE	Sambria Pharmaceuticals, Inc.	97345ed4-51c3-4221-852c-2cd563f33317	2025-11-12	Warnings	Exact identifier application number: M017
ZHENG GU SHUI	CAMPHOR, MENTHOL	GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD	17552943-4f11-42d6-ad41-fbc53f2bbd9a	2025-11-12	Warnings, Adverse reactions	Exact identifier application number: M017
NeuroMed FA	BENZOCAINE	Sambria Pharmaceuticals, Inc.	605fc242-ad31-4aa9-bd86-fba4ddf0d305	2025-11-12	Warnings	Exact identifier application number: M017
CAPZIX	CAPSAICIN	Toprail Chp Llc.	a4555840-cf8f-45d8-90bb-3581102b58a7	2025-11-12	Warnings	Exact identifier application number: M017
Hempvana Cold As Ice Pain Relief	MENTHOL	Telebrands Corp	95e84bb9-ba2e-5009-e053-2995a90a4362	2025-11-12	Warnings	Exact identifier application number: M017
Lidozall	LIDOCAINE HYDROCHLORIDE	V2 Pharma LLC	1eb2dfb2-3ad1-488b-aed9-17220e34a10c	2025-11-12	Warnings	Exact identifier application number: M017
Lidozall Plus	LIDOCAINE HYDROCHLORIDE	V2 Pharma LLC	ba3cbb15-f4ed-443e-af43-a758481acb0b	2025-11-12	Warnings	Exact identifier application number: M017
Knee Pain Relief Patch	DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE	Shenzhen Finona Information Technology Co., Ltd	38755738-1a06-fdb4-e063-6294a90aa6eb	2025-11-12	Warnings	Exact identifier application number: M017
Recovery Numb	LIDOCAINE 4%	PURKLENZ FORMULATIONS INC.	e95e38e3-f743-4f5c-abdf-99ba6856e6f7	2025-11-12	Warnings	Exact identifier application number: M017
Rapid Relief	COLD RELIEF PATCH 5% MENTHOL	RAPID AID VIET NAM COMPANY LIMITED	434c13c2-52ee-000f-e063-6294a90af7e7	2025-11-11	Warnings	Exact identifier application number: M017
Rapid Relief	PAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MG	RAPID AID VIET NAM COMPANY LIMITED	434d5f92-05c2-d884-e063-6394a90ad28c	2025-11-11	Warnings	Exact identifier application number: M017
Rapid Relief	PAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1%	RAPID AID VIET NAM COMPANY LIMITED	434df0be-49ff-aa56-e063-6394a90a3b5a	2025-11-11	Warnings	Exact identifier application number: M017
TopCare Pain Relief Maximum Strength	LIDOCAINE HYDROCHLORIDE	TOPCO ASSOCIATES	b0ae3a7c-52d1-4923-bd50-6bb3749006c8	2025-11-11	Warnings	Exact identifier application number: M017
Comfortcaine	LIDOCAINE HCL	QS Key West Aloe, LLC	831b7c11-e437-4e74-808e-c9c1eb8b82f6	2025-11-11	Warnings	Exact identifier application number: M017
A and E Marathon Delay Serum	DELAY SERUM	Phe Inc	4355d1d8-44fe-aca1-e063-6294a90a85ff	2025-11-11	Warnings	Exact identifier application number: M017
A and E Deep Throat Desensitizing SprayStrawberry	ORAL NUMBING SPRAY STRAWBERRY	Phe Inc	4355dab1-a293-ded6-e063-6394a90af9b0	2025-11-11	Warnings	Exact identifier application number: M017
A and E Easy Anal Gel	ANAL NUMBING LUBRICANT	Phe Inc	4355e0f3-65ba-eca6-e063-6394a90ab43c	2025-11-11	Warnings	Exact identifier application number: M017
A and E Deep Throat Desensitizing SprayPeppermint	ORAL NUMBING SPRAY MINT	Phe Inc	4355e0d0-1222-d594-e063-6294a90abb29	2025-11-11	Warnings	Exact identifier application number: M017
DermaNumb Analgesic	LIDOCAINE HCL	A.T.S. Laboratories, LLC	0ea46890-45c3-4732-bc47-227f7c67daf1	2025-11-11	Warnings	Exact identifier application number: M017
Derma Numb Pain Relief	LIDOCAINE HCL	A.T.S. Laboratories, LLC	710991ae-8f82-4893-93a7-0ef3f815d132	2025-11-11	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