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 126 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medicated Herbal Lip Balm	MENTHOL	Earth Mama Angel Baby LLC	1cc2391e-6a7a-609c-e063-6394a90a6305	2024-10-01	Warnings	Exact identifier application number: M017
CVS Health Lidocaine Plus Pain Relieving	LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL	NATURAL ESSENTIALS, INC.	1adb9b74-4a01-4461-b845-f3aedcb3f810	2024-10-01	Warnings	Exact identifier application number: M017
Circata	CAPSAICIN	PureTek Corporation	b67161d7-cc5c-e971-e053-2995a90acbe7	2024-10-01	Warnings	Exact identifier application number: M017
Menticam	CAMPHOR,MENTHOL, METHYL SALICYLATE	PureTek Corporation	ffea2e97-777f-434b-e053-6394a90a3a63	2024-10-01	Warnings	Exact identifier application number: M017
Herb Street Sore Muscle Relief	METHYL SALICYLATE	Balassa Laboratories Inc.	e43943c2-d4cd-44c5-a0ff-403a8d42860f	2024-10-01	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Kroger Company	68dab606-0385-48b7-9a7b-a2cf83d20393	2024-09-29	Warnings	Exact identifier application number: M017
kirkland signature hydrocortisone plus maximum strength	HYDROCORTISONE	Costco Wholesale Company	481341c5-db1f-43fb-aed7-f40495a4eab8	2024-09-29	Warnings	Exact identifier application number: M017
Care One hydrocortisone maximum strength	HYDROCORTISONE	American Sales Company	32593229-d0ac-4d6c-831a-089fc6e76152	2024-09-29	Warnings	Exact identifier application number: M017
good sense anti itch	HYDROCORTISONE	L. Perrigo Company	b7a896cc-1d78-45c0-a73e-aa1e117f7d3b	2024-09-29	Warnings	Exact identifier application number: M017
Topcare Hydrocortisone	HYDROCORTISONE	Topco Associates LLC	b7362f21-f1a3-4edc-b5b6-a16680e05df3	2024-09-29	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	H E B	412ca2d1-064b-4438-aee1-fcb5cf27c7db	2024-09-29	Warnings	Exact identifier application number: M017
Topcare Antibiotic	NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	Topco Associates LLC	8c349cac-20e1-4600-9b0a-fcfe929551c5	2024-09-26	Warnings	Exact identifier application number: M017
good sense anti itch	HYDROCORTISONE	A-S Medication Solutions	072dd455-24a5-4a44-aaef-d3e137d005a6	2024-09-26	Warnings	Exact identifier application number: M017
SYREN Intimate Relief	LIDOCAINE HYDROCHLORIDE	Icon Health Science	57d5a080-3583-4510-e053-2a91aa0ad589	2024-09-25	Warnings	Exact identifier application number: M017
AOSI HEALTHCARE	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	f4db90ad-dd62-44f1-9655-2614ed36581e	2024-09-25	Warnings	Exact identifier application number: M017
AOSI HEALTHCARE BURN	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	a28b920c-0bb8-4b5a-addd-26ea164e036e	2024-09-25	Warnings	Exact identifier application number: M017
anti itch	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Kroger Company	067e718a-ec0b-4895-8f9f-82d64ab4c7b4	2024-09-24	Warnings	Exact identifier application number: M017
topcare anti itch	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Topco Associates LLC	e0fb332a-2903-41ef-b35b-7cd3a74cff99	2024-09-24	Warnings	Exact identifier application number: M017
equaline anti itch	HYDROCORTISONE	United Natural Foods, Inc. dba UNFI	83cd9f60-a4c4-4dea-97a7-cd96aade9e88	2024-09-24	Warnings	Exact identifier application number: M017
good sense itch relief	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	L. Perrigo Company	162fe0a3-3995-4e6f-94ed-f839b2b0c80e	2024-09-24	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