RAYO POWER ICE HEAT DUAL ACTION

Product NDC: 83033-1602
11-digit product format: 830331602
Labeler code: 83033
Product ID: 83033-1602_48f80d39-675a-af9d-e063-6294a90a2eed
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Quimicas Handal de Centroamerica SA de CV
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-11-01
Substance: MENTHOL
Active strength: 1 g/g
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 · 14 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
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	83033-1602-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	83033-1602-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	83033-1602-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	83033-1602-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	83033-1602-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	83033-1602-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	83033-1602-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: RAYO POWER ICE HEAT DUAL ACTION
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	1 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5TJD82A1ET	Internal UNII lookup
LAV5U5022Y	Internal UNII lookup
L7T10EIP3A	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
09e4a36b-020a-c5b1-e063-6394a90a3e31	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
83033-1602-1	2025-05-02	C162847	48780-1	2cef2736-a143-d83d-e063-dadaa90ab31f	09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1602-1	2025-01-30	C162847	48780-1	2cef2736-a143-d83d-e063-dadaa90ab31f	09e4a36b-020a-c5b1-e063-6394a90a3e31

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83033-1602-1	RAYO POWER ICE HEAT DUAL ACTION	80 g in 1 TUBE, WITH APPLICATOR	GEL	80		3
83033-1602-1	RAYO POWER ICE HEAT DUAL ACTION	1 in 1 BOX	GEL	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83033-1602	RAYO ACTIVE HEAT (MENTHOL, METHYL SALICYLATE ) CREAM RAYO ACTIVE ICE (MENTHOL, CAMPHOR) CREAM RAYO BREATH CHAMOMILE (MENTHOL, CAMPHOR) CREAM RAYO BREATH MENTHOL (MENTHOL, CAMPHOR) CREAM RAYO POWER ICE HEAT DUAL ACTION (MENTHOL) GEL RAYO BREATH CHAMOMILE (MENTHOL, CAMPHOR) OINTMENT RAYO ACTIVE ICE SACHET (MENTHOL, CAMPHOR) CREAM [QUIMICAS HANDAL DE CENTROAMERICA SA DE CV]	2	Current NDC, 2 package rows	20250504_09e4a36b-020a-c5b1-e063-6394a90a3e31.zip

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 125 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
terrasil Bruise and Pain Relief Maximum Strength	CAMPHOR, MENTHOL	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	240b231d-a8b2-c64c-e063-6394a90a7440	2024-10-09	Warnings	Exact identifier application number: M017
Muscle Freeze Relief	MENTHOL	NATURAL ESSENTIALS, INC.	815c534b-096d-49f2-b5f2-8c885d45a5e6	2024-10-09	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE	VIVE HEALTH LLC	2410dc2f-9332-19fa-e063-6394a90a2835	2024-10-09	Warnings	Exact identifier application number: M017
CVS Health Lidocaine Pain-Relieving	LIDOCAINE	Natural Essentials, Inc.	fc23b2e2-4abc-4119-b8bd-305b4327f1dd	2024-10-09	Warnings	Exact identifier application number: M017
KERACARE	MENTHOL 1%	Avlon Industries, Inc.	f72eec6d-1204-4e03-8aed-d5bcf8d3bbce	2024-10-09	Warnings	Exact identifier application number: M017
Eagle Medicated	MENTHOL METHYL SALICYLATE	Eagle Indo Pharma, PT	da338796-de9c-be51-e053-2a95a90a2509	2024-10-07	Warnings	Exact identifier application number: M017
Eagle Medicated	MENTHOL METHYL SALICYLATE	Eagle Indo Pharma	e2c5f821-cdd5-190d-e053-2a95a90a9159	2024-10-07	Warnings	Exact identifier application number: M017
NanoXtreme Pain Relieving	MENTHOL, METHYL SALICYLATE	MG Science Technologies LLC	c1490c30-a9db-4120-adaf-9e8000169e46	2024-10-07	Warnings	Exact identifier application number: M017
CAREALL Hydrocortisone Maximum Strength	HYDROCORTISONE	New World Imports, Inc	ea656cf8-cad5-4fa5-82e7-daec77a0bb04	2024-10-07	Warnings	Exact identifier application number: M017
Eagle Medicated Oil Refreshing	MENTHOL, METHYL SALICYLATE	Eagle Indo Pharma, PT	e2729023-d689-7ae2-e053-2a95a90a78dc	2024-10-06	Warnings	Exact identifier application number: M017
Flanax Back Pain Relief	LIDOCAINE	Belmora LLC	46d33346-e582-4af1-b81a-feca7033dceb	2024-10-04	Warnings	Exact identifier application number: M017
Muscle Balm	MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC)	Natural Essentials, Inc.	16918ba3-2e07-4232-9ed3-4c7751796cd2	2024-10-04	Warnings	Exact identifier application number: M017
Fast Freeze Pain Relieving Continuous	MENTHOL, UNSPECIFIED FORM	Natural Essentials, Inc.	998a4824-9ed9-4fe0-b45b-72e52861fcd3	2024-10-04	Warnings	Exact identifier application number: M017
Fast Freeze Lidocaine Roll-On	LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL	Natural Essentials, Inc.	74b06366-5eb4-4eba-aa2b-2b672828294d	2024-10-04	Warnings	Exact identifier application number: M017
Fast Freeze Lidocaine	LIDOCAINE	Natural Essentials, Inc.	029bd3fb-1b5b-48e0-b9af-d91d548b5b0f	2024-10-04	Warnings	Exact identifier application number: M017
Fast Freeze	MENTHOL	Natural Essentials Inc.	a96e3e41-871c-4cf3-93b6-af2a6246ded8	2024-10-04	Warnings	Exact identifier application number: M017
CVS Pain Relief	MENTHOL 4%	CVS	20234356-5e80-b79e-e063-6294a90a2ee3	2024-10-04	Warnings	Exact identifier application number: M017
FLANAX BACK PAIN RELIEF	LIDOCAINE	Belmora Llc	af4bf57c-f250-4506-83eb-e0f253e96062	2024-10-04	Warnings	Exact identifier application number: M017
topcare hydrocortisone	HYDROCORTISONE	Topco Associates LLC	11a30ec9-ebc2-4a00-8a8d-431d0d973b37	2024-10-03	Warnings	Exact identifier application number: M017
pain relief patch	LIDOCAINE 4%	Bionpharma Inc.	19c69983-4e78-8ec5-e063-6394a90a84be	2024-10-03	Warnings	Exact identifier application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
83033-1602-1	83033160201	1 TUBE, WITH APPLICATOR in 1 BOX (83033-1602-1) / 80 g in 1 TUBE, WITH APPLICATOR	2023-11-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RAYO ACTIVE HEAT - Quimicas Handal de Centroamerica SA de CV	Quimicas Handal de Centroamerica SA de CV	2026-01-22	HUMAN OTC DRUG LABEL	3