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 147 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BODY ACTION PRODUCTS Endless Love for Men	BENZOCAINE	PRODUCT MAX GROUP INC	d0fa792d-dc04-4bdf-a22d-dea896beae5b	2023-11-10	Warnings	Exact identifier application number: M017
Endless Love For Men	BENZOCAINE	Body Action Products, Inc	4e89cd3a-ecad-44c3-acb3-6d0810add8c0	2023-11-10	Warnings	Exact identifier application number: M017
BODY ACTION PRODUCTS Higher Control Male Climax	BENZOCAINE	PRODUCT MAX GROUP INC	3c7fa73b-abe8-4a8d-951c-4e785d6e812c	2023-11-10	Warnings	Exact identifier application number: M017
Uber Numb	LIDOCAINE HYDROCHLORIDE	UBERScientific, LLC	65a319a6-89d2-44c9-81d5-30327f9948cb	2023-11-10	Warnings	Exact identifier application number: M017
Uber Numb	LIDOCAINE HYDROCHLORIDE	UBERScientific, LLC	768f3f0e-1add-404f-b869-00a9f35ad34a	2023-11-10	Warnings	Exact identifier application number: M017
Zcaine Fast Acting Anesthetic	LIDOCAINE	PHI, Inc	d072243f-6ba6-4ab6-8ebf-a2381fa9c2df	2023-11-09	Warnings	Exact identifier application number: M017
Plum Smooth Plumb Numb Gelee	LIDOCAINE	Universal Companies, Inc.	6be7d8e0-6cd0-4da2-926f-3dbb3db3bd8e	2023-11-09	Warnings	Exact identifier application number: M017
Sonacaine Topical Anesthetic With Menthol	LIDOCAINE	Filltech USA, LLC	ca54c6da-4bf2-4e63-ba7f-a69c4f9c431a	2023-11-09	Warnings	Exact identifier application number: M017
Bed Bug Instant Bite Relief	LIDOCAINE	P.F. Harris Mfg. Co. LLC	7f472fd0-5605-4cc6-b4b2-1267e815255c	2023-11-09	Warnings	Exact identifier application number: M017
Valtrum Aerobic Sports	SALICYLIC ACID MENTHOL CAMPHOR (NATURAL)	LABORATORIOS QUANTIUM LLC	33f2491e-c1f2-4e5a-acbe-8ace844b88d6	2023-11-09	Warnings	Exact identifier application number: M017
Valtrum Topical Analgesic Roll On	SALICYLIC ACID MENTHOL CAMPHOR (NATURAL)	LABORATORIOS QUANTIUM LLC	28167e2a-9afb-44e7-90c7-9577df9504b6	2023-11-09	Warnings	Exact identifier application number: M017
Satohap Cool Type	CAMPHOR, MENTHOL, METHYL SALICYLATE	Sato Pharmaceutical Co., Ltd.	fe07a00a-2699-44d3-887d-bd068948ad7b	2023-11-07	Warnings	Exact identifier application number: M017
Hims Delay Wipes	BENZOCAINE WIPES	Hims Inc.	adbead3d-dca0-4919-b688-44c88f779e5a	2023-11-07	Warnings	Exact identifier application number: M017
Bakers Best Maximum Strength Pain Relief	LIDOCAINE HYDROCHLORIDE, MENTHOL	Baker's Best Health Products, LLC	9d160ff1-9c23-4a5d-82b3-82c2e1e7d34d	2023-11-06	Warnings	Exact identifier application number: M017
BAKERS BEST Pain Relief with Pure Hemp Seed Oil	LIDOCAINE HYDROCHLORIDE, MENTHOL	BAKER'S BEST HEALTH PRODUCTS, INC.	ae54c234-bfe4-4a74-b293-db7efda7884b	2023-11-06	Warnings	Exact identifier application number: M017
Arth RX Topical Analgesic	METHYL NICOTINATE, CAPSAICIN	HCD Sales	a7b3b9b4-b1c4-4e51-8e3a-c84f64c75609	2023-11-06	Warnings	Exact identifier application number: M017
BAKERS BEST Arthritis Pain Relief Cream with Hemp and Lavender	HISTAMINE DIHYDROCHLORIDE	BAKER'S BEST HEALTH PRODUCTS, INC.	03ec87c5-6669-4afb-8d9c-c8dc9907495d	2023-11-06	Warnings	Exact identifier application number: M017
DOCTORS TOUCH Erase The Pain	MENTHOL	DOCTOR'S CHOICE MEDICAL, LLC	fe9ce2c7-d6af-4dad-b6e6-5049a9e091b0	2023-11-06	Warnings	Exact identifier application number: M017
RadiaGuard Advanced Radiation Relief	LIDOCAINE HYDROCHLORIDE	SMOOTH SIDE, INC	21205087-5a2e-41a5-be40-30cba2895408	2023-11-06	Warnings	Exact identifier application number: M017
BLUE SPRING Foot and Leg Comfort	MENTHOL	ACA MANAGEMENT LLC	5f52218d-eea4-4640-b820-84c077ab98ba	2023-11-06	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