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
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
83033-1609-1	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 109 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health, Inc	26a55d74-f772-5d17-e063-6394a90a5583	2025-08-07	Warnings	Exact identifier application number: M012
Daytime Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	H E B	b7434978-44a8-4c51-979d-0bc446461e43	2025-08-06	Warnings	Exact identifier application number: M012
Tussin DM	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS Pharmacy	fc1e224c-5c57-43fc-ae6e-36aa0a4ae439	2025-08-06	Warnings	Exact identifier application number: M012
childrens cold cough dm	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Publix Super Markets Inc	6efe7097-2a99-4654-9d94-b47f2e64d19d	2025-08-05	Warnings	Exact identifier application number: M012
Quality Choice Throat Soothing Drops Creamy Strawberry	PECTIN	Chain Drug Marketing Association, Inc.	3b7548ee-7cd3-62c3-e063-6294a90a0612	2025-08-03	Warnings	Exact identifier application number: M012
Vaporizing chest rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	LJ Pharma	065bb666-e482-4e96-ac75-c6577dcc5b48	2025-08-01	Warnings	Exact identifier application number: M012
Nighttime Cough-Kids	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Genexa	024bb864-4214-1d8b-e063-6394a90aa573	2025-08-01	Warnings	Exact identifier application number: M012
Antigrip Cough and Cold	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Pharmadel LLC	3b53e5fc-f258-c2b9-e063-6394a90ab500	2025-08-01	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Major Pharmaceuticals	1b591e27-b00b-41c8-9fe9-c633aba09134	2025-08-01	Warnings	Exact identifier application number: M012
meijer Nighttime Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Meijer, Inc.	377248b6-d64d-8dff-e063-6394a90a43f6	2025-07-31	Warnings	Exact identifier application number: M012
meijer Daytime Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Meijer, Inc.	3771f778-7ac9-7108-e063-6394a90a1105	2025-07-31	Warnings	Exact identifier application number: M012
tussin dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS Pharmacy	087d7774-9b0f-44f6-bc1b-4dfbd2f2f6ca	2025-07-31	Warnings	Exact identifier application number: M012
Equate Nasal	OXYMETAZOLINE HCL	Wal-Mart Stores Inc	c38a2783-aed9-466d-8976-59d03a792c04	2025-07-30	Warnings	Exact identifier application number: M012
Quality Choice Throat Soothing Drops Creamy Strawberry	PECTIN	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3b15d2ea-f784-275d-e063-6394a90a800c	2025-07-29	Warnings	Exact identifier application number: M012
Respiratory Relief	GUAIFENESIN	Schwabe North America, Inc	f683041a-4ff9-42a5-9047-a9a3140a8758	2025-07-29	Warnings	Exact identifier application number: M012
Childrens Robitussin Honey Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	b87f700e-3414-463c-80d4-c3dbca89a488	2025-07-29	Warnings	Exact identifier application number: M012
Tussin DM	TUSSIN DM	Allegiant Health	7a2f8d48-3123-4c37-b238-bd7cc4242bb7	2025-07-23	Warnings	Exact identifier application number: M012
Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREE	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	GADAL Laboratories, Inc	5fb2438b-8f2d-4af2-9981-42d278d26800	2025-07-23	Warnings	Exact identifier application number: M012
DR. SANA COUGH AND CHEST CONGESTION DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	GADAL Laboratories, Inc	baca0580-4c30-4b94-89fa-a7cf06d4ff25	2025-07-22	Warnings	Exact identifier application number: M012
Defensol D	ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI	Menper Distributors, Inc.	f466c660-69eb-4581-81ff-1499fa421d8b	2025-07-22	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