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 105 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Biofreeze Professional	MENTHOL, UNSPECIFIED FORM	A-S Medication Solutions	cbeac814-59d8-4c13-8e73-bca66f797f8d	2025-01-09	Warnings	Exact identifier application number: M017
Bactine Max	LIDOCAINE	WellSpring Pharmaceutical Corporation	acd7ae37-7c42-4ec7-a2ef-42e7f628388d	2025-01-08	Warnings	Exact identifier application number: M017
THERABLAST MAXIMUM RELIEF	LIDOCAINE, MENTHOL	Releaf Technologies LLC	09809985-3a88-9bb7-e063-6394a90a2f5f	2025-01-08	Warnings	Exact identifier application number: M017
ANTI ITCH	HYDROCORTISONE	Safeway	0bfa1653-76b7-48ed-a896-a0b5fc3bd794	2025-01-08	Warnings	Exact identifier application number: M017
Sting Relief Swab	BENZOCAINE	Epic Medical Supply Corp	259fbfe4-d67c-ea1e-e063-6294a90a0fb0	2025-01-07	Warnings	Exact identifier application number: M017
Sinsin Mulpas	CAMPHOR, MENTHOL, METHYL SALICYLATE	Sinsin Pharmaceutical Co., Ltd.	22ea8a51-fdee-4650-abf8-f996268c9303	2025-01-07	Warnings	Exact identifier application number: M017
SINSINPAP COOL	LEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUS	Sinsin Pharmaceutical Co., Ltd.	9d47855f-ccb5-4557-a31a-a2b336fa9806	2025-01-07	Warnings	Exact identifier application number: M017
Burn Jel	LIDOCAINE HYDROCHLORIDE	Water-Jel Technologies	ff621b46-2342-41db-994d-851a09796d08	2025-01-06	Warnings	Exact identifier application number: M017
Lidocare Arm, Neck, Leg	4% LIDOCAINE	Kingsway Pharmaceuticals dba NFI, LLC	59a104ee-7034-99c3-e053-2991aa0a164c	2025-01-06	Warnings	Exact identifier application number: M017
Salonpas LIDOCAINE Pain Relieving	LIDOCAINE	Hisamitsu Pharmaceutical Co., Inc.	4f3a438c-f378-4d2a-a95c-58e56cf1e797	2025-01-06	Warnings	Exact identifier application number: M017
Lidocare 03	4% LIDOCAINE	Kingsway Pharmaceuticals dba NFI, LLC	416ebf5a-2efb-6d0b-e054-00144ff88e88	2025-01-06	Warnings	Exact identifier application number: M017
AVCOO Pain Relief Roll-on	MENTHOL	ADP Health Limited	e0bb77b2-45ee-45fa-9659-9c7d99bb20dc	2025-01-05	Warnings	Exact identifier application number: M017
health and beyond BURN	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	0b6bb3ed-50fb-40c4-acb6-ae3f16031531	2025-01-05	Warnings	Exact identifier application number: M017
glo SKIN BEAUTY Remedy Gel	GLO SKIN BEAUTY REMEDY GEL	Hayden Caleel LLC	aa47ff08-07b3-4fd1-bae5-420e4b928f06	2025-01-05	Warnings	Exact identifier application number: M017
Capsaicin 0.025% Cream	CAPSAICIN 0.025%	Puretek Corporation	28f00df0-c416-f17b-e063-6294a90a5570	2025-01-02	Warnings	Exact identifier application number: M017
AVON HeXashield Pain Relief for Muscle, Back and Joint Cream	CAMPHOR, MENTHOL, METHYL SALICYLATE	Tai Guk Pharm. Co., Ltd.	8f29ffd7-48b9-109f-e053-2995a90ab215	2025-01-01	Warnings	Exact identifier application number: M017
AVON HeXashield Arthritis Pain Relief Cream Capsaisin	CAPSAISIN	Tai Guk Pharm. Co., Ltd.	8f286a9d-8765-21b3-e053-2a95a90ae43a	2025-01-01	Warnings	Exact identifier application number: M017
AVON HeXashield Anti Itch Cream with Healing Aloe	HYDROCORTISONE	Tai Guk Pharm. Co., Ltd.	8f2aa11d-d794-6f3e-e053-2995a90a1d9d	2025-01-01	Warnings	Exact identifier application number: M017
HeXashield Anti Itch Cream with Healing Aloe	HYDROCORTISONE	Tai Guk Pharm. Co., Ltd.	b9d033f3-4d12-a2c8-e053-2995a90ac7f1	2025-01-01	Warnings	Exact identifier application number: M017
Green Compass Reduce Pain Relief with Menthol	MENTHOL	Green Compass, Inc.	0a0c212e-ae5d-8505-e063-6394a90af622	2025-01-01	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