RAYO ACTIVE ICE SACHET

Product NDC: 83033-1609
11-digit product format: 830331609
Labeler code: 83033
Product ID: 83033-1609_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	83033-1609-1	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	83033-1609-1	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	83033-1609-1	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	83033-1609-1	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	83033-1609-1	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	83033-1609-1	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	83033-1609-1	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 SACHET
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
LAV5U5022Y	Internal UNII lookup
L7T10EIP3A	Internal UNII lookup
5TJD82A1ET	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
83033-1609-1	2025-05-02	C162847	48780-1	2cef2736-a143-d83d-e063-dadaa90ab31f	09e4a36b-020a-c5b1-e063-6394a90a3e31
83033-1609-1	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
83033-1609-1	RAYO ACTIVE ICE SACHET	4 g in 1 POUCH	CREAM	4		3
83033-1609-1	RAYO ACTIVE ICE SACHET	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
83033-1609	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 57 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreens NightTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	WALGREEN COMPANY	5bf72e2f-15c8-466a-9e13-50654233da91	2026-01-19	Warnings	Exact identifier application number: M012
Cold and Flu Daytime, Nighttime, Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreens	9862f84d-1c18-4ef7-86dc-98572599d417	2026-01-19	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreens	37853689-c9ca-4bc7-9c5b-4a68b8d778be	2026-01-19	Warnings	Exact identifier application number: M012
VAPORX	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	AKRON PHARMA INC	51b32162-0c5a-4b5b-999a-34337d816603	2026-01-19	Warnings	Exact identifier application number: M012
Equate	OXYMETAZOLINE HCL	Walmart Inc	2f762c24-2442-506a-e063-6394a90a3b96	2026-01-19	Warnings	Exact identifier application number: M012
Dimetane	DIPHENHYDRAMINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f	2026-01-19	Warnings	Exact identifier application number: M012
nitetime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Publix Super Markets Inc	f681d986-9838-42d8-8ed9-732a39fbf870	2026-01-19	Warnings	Exact identifier application number: M012
Nasal Decongestant	PSEUDOEPHEDRINE HCL	H E B	22d241c5-a3fd-4619-8147-91d7a4c8cf98	2026-01-19	Warnings	Exact identifier application number: M012
Nasal Decongestant Maximum Strength	PSEUDOEPHEDRINE HCL	Better Living Brands, LLC	9fe63ca6-3863-4175-9aec-ecd6ebbdb249	2026-01-19	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Night Time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Amerisource Bergen	5749ce9d-e182-478f-ab88-b520a35a99a7	2026-01-19	Warnings	Exact identifier application number: M012
Foster and Thrive Daytime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Strategic Sourcing Services LLC	1d9150b1-2f6c-4c33-8c93-3ed1d88585e2	2026-01-18	Warnings	Exact identifier application number: M012
HealthWise Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	Veridian Healthcare	ce3ceffd-3ff5-3795-e053-2995a90a827f	2026-01-18	Warnings	Exact identifier application number: M012
topcare nite time cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Topco Associates LLC	31210a95-f9dc-49db-aab5-25c4dca49266	2026-01-17	Warnings	Exact identifier application number: M012
Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Procter & Gamble Manufactura S de RL de CV	f77226c0-b6d5-9fd0-e053-6294a90a4b57	2026-01-16	Warnings	Exact identifier application number: M012
Vicks DayQuil NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Procter & Gamble Manufactura S de RL de CV	f691734b-5cf4-6eb8-e053-2a95a90aee80	2026-01-16	Warnings	Exact identifier application number: M012
Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Procter & Gamble Manufactura S de RL de CV	f771aa19-295a-9f4e-e053-6294a90a1674	2026-01-16	Warnings	Exact identifier application number: M012
CVS Cherry Cough Drops	MENTHOL	CVS Pharmacy	de5c4b94-0420-5d43-e053-2995a90aa5a5	2026-01-16	Warnings	Exact identifier application number: M012
CVS Honey Lemon Cough Drops	MENTHOL	CVS Pharmacy	de963dc3-8108-440f-e053-2995a90a906f	2026-01-16	Warnings	Exact identifier application number: M012
CVS SF Menthol Cough Drops	MENTHOL	CVS Pharmacy	e08f8ca3-b683-4964-e053-2a95a90afabb	2026-01-16	Warnings	Exact identifier application number: M012
CVS SF Honey Lemon Cough Drops	MENTHOL	CVS Pharmacy	e0cdeccf-c32f-318a-e053-2a95a90ac401	2026-01-16	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
83033-1609-1	83033160901	1 POUCH in 1 BOX (83033-1609-1) / 4 g in 1 POUCH	1 pouch	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