RAYO ACTIVE HEAT

Product NDC: 83033-1601
11-digit product format: 830331601
Labeler code: 83033
Product ID: 83033-1601_48f80d39-675a-af9d-e063-6294a90a2eed
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL, METHYL SALICYLATE
Dosage form: CREAM
Route: TOPICAL
Labeler: Quimicas Handal de Centroamerica SA de CV
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-11-01
Substance: MENTHOL; METHYL SALICYLATE
Active strength: 1; 1 g/g; 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	83033-1601-1	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	83033-1601-1	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	83033-1601-1	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	83033-1601-1	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	83033-1601-1	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	83033-1601-1	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	83033-1601-1	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 ACTIVE HEAT
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	1 g/g
METHYL SALICYLATE	1 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup
5TJD82A1ET	Internal UNII lookup
LAV5U5022Y	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
83033-1601-1	2025-05-02	C162847	48780-1	2cef2736-a143-d83d-e063-dadaa90ab31f	09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1601-1	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
83033-1601-1	RAYO ACTIVE HEAT	226.8 g in 1 TUBE	CREAM	226.8		3
83033-1601-1	RAYO ACTIVE HEAT	1 in 1 BOX	CREAM	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83033-1601	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 136 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SunBurnt PLUS	LIDOCAINE HYDROCHLORIDE	Quest Products, LLC.	12128c75-015d-8a72-e063-6394a90ae00a	2024-02-23	Warnings	Exact identifier application number: M017
Kroger Analgesic Analgesic	LIDOCAINE HYDROCHLORIDE	THE KROGER CO	e6c5ead3-87d0-48ed-a4dc-86cf89ebb285	2024-02-22	Warnings	Exact identifier application number: M017
Rugby Pain Relieving Analgesic	MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE	Bryant Ranch Prepack	fcf48536-224e-4a3d-9124-770031823972	2024-02-22	Warnings	Exact identifier application number: M017
meijer ROLL-ON Cold Therapy Pain Relieving Topical analgesic	MENTHOL, UNSPECIFIED FORM	Meijer Distribution, Inc	8bc3956b-b82d-4ed3-8bc3-db0078466bbc	2024-02-22	Warnings	Exact identifier application number: M017
Promescent Delay Wipes	BENZOCAINE	Absorption	f0a5b6be-acc5-473c-9054-b9534e769db1	2024-02-20	Warnings	Exact identifier application number: M017
Ralli Rapid Pain Relief	MENTHOL	Troy Manufacturing, Inc.	721658dc-3b1d-43ff-9032-e96851633cf9	2024-02-19	Warnings	Exact identifier application number: M017
Ralli Rapid Pain Relief Roll on	MENTHOL	Troy Manufacturing, Inc.	978d5c2c-fdc4-4d25-83ec-0b9404ec8018	2024-02-19	Warnings	Exact identifier application number: M017
1168	1168 BURN SPRAY	Dynarex Corporation	1183a4f5-f875-dfb0-e063-6394a90af35f	2024-02-16	Warnings	Exact identifier application number: M017
Pain Relief	BENZOCAINE	Safetec of America, Inc.	de84e598-d047-4fae-b2ed-155a3788bc6f	2024-02-16	Warnings	Exact identifier application number: M017
No Mess Hydrocortisone Applicator	HYDROCORTISONE	Walgreen Co.	cfefb517-9099-41c4-8a95-74414ca4032c	2024-02-16	Warnings	Exact identifier application number: M017
Analgesic Balm	MENTHOL 10%, METHYL SALICYLATE 15%	Geri-Care Pharmaceuticals, Corp	ab9bf09d-bc8c-6d17-e053-2995a90a6c36	2024-02-14	Warnings	Exact identifier application number: M017
Natures Oil 16% Menthol	MENTHOL, UNSPECIFIED FORM	NATURAL ESSENTIALS, INC.	2fbe23b7-23a3-4f0b-bc08-0205256f5d68	2024-02-14	Warnings	Exact identifier application number: M017
Rugby Pain Relieving Analgesic	MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE	Rugby Laboratories	4c11876c-57ec-4429-a8c4-fb95baa4074a	2024-02-13	Warnings	Exact identifier application number: M017
Itch stopping Cream	DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%	Trifecta Pharmaceuticals USA, LLC.	11368823-d4af-a536-e063-6294a90a7a2e	2024-02-12	Warnings	Exact identifier application number: M017
Walgreens Boil Pain Relief	BOIL PAIN RELIEF	Walgreens Company	d11bd769-68d0-4057-bc2a-72719f16011e	2024-02-12	Warnings	Exact identifier application number: M017
Capsaicin	CAPSAICIN	Rugby Laboratories	c5915c84-84a2-46f6-9f97-0d9873e9944a	2024-02-12	Warnings	Exact identifier application number: M017
Leader Ice Blue Analgesic	MENTHOL, UNSPECIFIED FORM	Cardinal Health, 110 dba LEADER	952e56ea-5cbc-4078-bd01-5d3b6864a5ce	2024-02-09	Warnings	Exact identifier application number: M017
Leader Ultra Strength Muscle Rub Topical Analgesic	CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE	Cardinal Health, 110 dba LEADER	9d99a900-60e0-454c-98e0-2c63eb910cf1	2024-02-09	Warnings	Exact identifier application number: M017
Pain Relieving	CAMPHOR (NATURAL)	J.R. Watkins, LLC.	28821ffa-a138-47b5-8857-beadf7a20d43	2024-02-08	Warnings	Exact identifier application number: M017
Menthol Camphor Cough Suppressant Topical Analgesic Rub	CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM	J.R. Watkins, LLC.	fd0ea70a-ef12-48b1-8d9d-cc5f6417f854	2024-02-08	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83033-1601-1	83033160101	1 TUBE in 1 BOX (83033-1601-1) / 226.8 g in 1 TUBE	1 tube	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