RAYO ACTIVE ICE

Product NDC: 83033-1600
11-digit product format: 830331600
Labeler code: 83033
Product ID: 83033-1600_48f80d39-675a-af9d-e063-6294a90a2eed
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL, CAMPHOR
Dosage form: CREAM
Route: TOPICAL
Labeler: Quimicas Handal de Centroamerica SA de CV
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-11-01
Substance: MENTHOL; CAMPHOR (SYNTHETIC)
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	83033-1600-1	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	83033-1600-1	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	83033-1600-1	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	83033-1600-1	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	83033-1600-1	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	83033-1600-1	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	83033-1600-1	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 ICE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	1 g/g
CAMPHOR (SYNTHETIC)	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
83033-1600-1	2025-05-02	C162847	48780-1	2cef2736-a143-d83d-e063-dadaa90ab31f	09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1600-1	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
83033-1600-1	RAYO ACTIVE ICE	1 in 1 BOX	CREAM	1		3
83033-1600-1	RAYO ACTIVE ICE	226.8 g in 1 TUBE	CREAM	226.8		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83033-1600	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 118 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HISTEX-DM New Formulation	DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCI, AND TRIPROLIDINE HCI	Allegis Pharmaceuticals, LLC	30010401-e5b4-2bd9-e063-6394a90a0b0b	2025-03-10	Warnings	Exact identifier application number: M012
daytime severe cold multi-symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	cc7c5f1c-76b7-4278-8e2a-5fbc85e022dd	2025-03-08	Warnings	Exact identifier application number: M012
Cold and Head Congestion Relief Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	WinCo Foods, LLC	a39778ba-1f63-4495-8e9b-44b0bdd7f71a	2025-03-08	Warnings	Exact identifier application number: M012
Extra Strength TYLENOL Severe Cough Plus Sore Throat Day	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	2e9540e4-bd1d-9370-e063-6294a90affcb	2025-03-07	Warnings	Exact identifier application number: M012
Herbal Cough Drops Original Herb	COUGH DROPS	Topco Associates LLC	2fb22181-aee3-d0bf-e063-6294a90a7865	2025-03-06	Warnings	Exact identifier application number: M012
REVASOL DAYTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Rnv LLC	2f9ddcc3-b913-f8b0-e063-6294a90a93ab	2025-03-05	Warnings	Exact identifier application number: M012
Herbal Throat Drops Lemon Mint Herb	THROAT DROPS	Topco Associates LLC	2fa086b4-3b0e-0df8-e063-6294a90a6769	2025-03-05	Warnings	Exact identifier application number: M012
Redicare Nasal and Sinus Decongestant	REDICARE NASAL AND SINUS DECONGESTANT	Redicare LLC	2f24be68-f30e-d916-e063-6294a90a7e31	2025-03-04	Warnings	Exact identifier application number: M012
Diphenhydramine HCl Oral Solution	DIPHENHYDRAMINE HCL ORAL SOLUTION	Kesin Pharma Corporation	2f871005-de4d-8b2a-e063-6394a90aa43a	2025-03-04	Warnings	Exact identifier application number: M012
CVS Daytime Cough Relief Chews - Citrus Punch	DEXTROMETHORPHAN HBR	CVS	2f885f1b-7ff5-251b-e063-6394a90a656f	2025-03-04	Warnings	Exact identifier application number: M012
CVS Dex-Dox Kids Nighttime Cough Suppressant	DEXTROMETHORPHAN HBR	CVS	2f8b6f5e-399c-b033-e063-6294a90ac3d1	2025-03-04	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	Pioneer Life Sciences, LLC	ff8b096c-8f01-4a8c-a98f-e4aa4d688e95	2025-03-04	Warnings	Exact identifier application number: M012
Menthol Cough Drops Honey Vanilla Flavor	MENTHOL	7-ELEVEN	2f3c43dd-175f-722e-e063-6294a90acff9	2025-02-28	Warnings	Exact identifier application number: M012
Menthol Cough Drops Creamy Strawberry Flavor	MENTHOL AND PECTIN	7-ELEVEN	2f3c3c65-4178-6304-e063-6294a90a51fa	2025-02-28	Warnings	Exact identifier application number: M012
Menthol Cough Drops Creamy Strawberry Flavor	MENTHOL AND PECTIN	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2efbffd7-bbdd-c5f5-e063-6294a90a15f0	2025-02-25	Warnings	Exact identifier application number: M012
Menthol Cough Drops Honey Vanilla Flavor	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2efc46c9-a421-1998-e063-6394a90aeb64	2025-02-25	Warnings	Exact identifier application number: M012
Redicare Cough Drops Cherry Flavored	CHERRY FLAVORED MENTHOL COUGH DROPS	Redicare LLC	2efeaafa-ee96-37ee-e063-6394a90a9a4b	2025-02-25	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HCL	Genexa Inc.	e880b8d7-61c3-41cc-e053-2995a90aaaeb	2025-02-20	Warnings	Exact identifier application number: M012
Gencare-Nasal Decongestant PE	PHENYLEPHRINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	596ec923-56a0-4b6e-a69c-8d740feb75a2	2025-02-20	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-pack	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	77a2dc96-73ee-4ca2-b1fe-406995802606	2025-02-19	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5TJD82A1ET	CAMPHOR (SYNTHETIC)	76-22-2	CAMPHOR (SYNTHETIC)

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83033-1600-1	83033160001	1 TUBE in 1 BOX (83033-1600-1) / 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