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
5TJD82A1ET	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
83033-1609-1	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 177 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tussin Mucus and Chest Congestion Sugar Free	GUAIFENESIN	AARNA USA, Inc.	6e488782-0138-436d-a9f0-0ec5bc9daedd	2023-05-15	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN	KROGER COMPANY	813b1db2-a177-77c6-e053-2a91aa0ac73b	2023-01-17	Warnings	Exact identifier application number: M012
MUCUS RELIEF DM	DEXTROMETHORPHAN HBR/GUAIFENESIN	KROGER COMPANY	813baf42-edb0-33a9-e053-2a91aa0a8599	2023-01-17	Warnings	Exact identifier application number: M012
Daytime Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	H-E-B	db19b8c7-0334-0664-e053-2a95a90ad61f	2023-01-14	Warnings	Exact identifier application number: M012
Nightime	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	H-E-B	db44560b-da02-74c9-e053-2a95a90af0b6	2023-01-13	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL	Walgreens	dbf5656b-9105-871b-e053-2995a90a4941	2023-01-03	Warnings	Exact identifier application number: M012
DAYTIME-NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	KROGER	a2508699-08c0-4a22-e053-2a95a90a8a6d	2022-11-02	Warnings	Exact identifier application number: M012
GUAIFENESIN	GUAIFENESIN	PAI Holdings, LLC dba PAI Pharma	c2e53fb5-2798-47c8-9285-d1077d46e629	2022-06-14	Warnings	Exact identifier application number: M012
Mucus Relief DM	MUCUS RELIEF DM	TopCo Associates, LLC	71674a9b-89ed-43d1-aadb-b9311fdfbdf9	2022-06-07	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu Relief Combo Pack	DAYTIME NIGHTTIME COLD AND FLU	Allegiant Health	fa7ed5db-4da7-46b4-a08d-1d79cb7a5674	2022-05-19	Warnings	Exact identifier application number: M012
Mucus Relief DM Immediate Release	MUCUS RELIEF DM	Good Sense	26a199bf-57e5-4f36-b40c-83a1187e4870	2022-05-18	Warnings	Exact identifier application number: M012
Mucus Relief DM Immediate Release	MUCUS RELIEF DM	Allegiant Health	731f8608-ad5b-491e-a4d4-2bb0c423fed5	2022-05-18	Warnings	Exact identifier application number: M012
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	OPMX LLC	b3c229a4-c772-70fb-e053-2a95a90a72db	2022-03-11	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	Good Sense	f88e2654-8e97-4cf6-9c36-01aeb51a9102	2021-11-30	Warnings	Exact identifier application number: M012
Cold Medicine	COLD MEDICINE	Allegiant Health	443fbc44-2c33-4316-ad31-dcc5a5aa8f52	2021-11-23	Warnings	Exact identifier application number: M012
Decongestant PE Non Drowsy	PHENYLEPHRINE HCL	Allegiant Health	7a3098b4-381c-4f32-97a7-87b53fd64428	2021-06-16	Warnings	Exact identifier application number: M012
Mucus Relief Immediate Release	GUAIFENESIN 400MG	Good Sense	e7c68746-7ec0-46cf-b4a3-174fab819b5e	2021-05-05	Warnings	Exact identifier application number: M012
Mucus Relief Immediate Release	GUAIFENESIN 400MG	TopCo Associates, LLC	7d91c6ab-d161-42b9-b353-0aa8f59619f8	2021-01-21	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MG	Allegiant Health	bed5f9dc-45ea-4e90-86c6-86599b6f3861	2020-11-16	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN	Allegiant Health	b97126d7-847d-483e-b3d1-e2b61ab1743f	2020-11-11	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