COOLING

Product NDC: 82551-119
Requested package NDC: 82551-119-14
11-digit product format: 825510119
Labeler code: 82551
Product ID: 82551-119_deeb20db-6247-965f-e053-2a95a90a1164
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: GEL
Route: TOPICAL
Labeler: FULL EIGHT LLC
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2022-01-26
Marketing end: 0000-00-00
Substance: MENTHOL
Active strength: 1 g/100mL
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	82551-119	82551-119-14	I	Inactivated by FDA		2026-10-05

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	82551-119	82551-119-14	I	Inactivated by FDA		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	82551-119	82551-119-14	I	Inactivated by FDA		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
82551-119-14	2025-07-29	C162847	48780-1	3b156c62-28d6-fb37-e063-e6dba90a4e07	FULL EIGHT - COOLING GEL (82551-119)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82551-119-14	COOLING	118 mL in 1 BOTTLE	GEL	118		13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82551-119	COOLING (MENTHOL) GEL [FULL EIGHT INC]	13	Legacy NDC, 1 package rows	20241016_d699de4e-f6a8-5255-e053-2a95a90a4fe7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2045038	menthol 1.2 % Topical Gel	PSN	d699de4e-f6a8-5255-e053-2a95a90a4fe7	13
2045038	menthol 0.012 MG/MG Topical Gel	SCD	d699de4e-f6a8-5255-e053-2a95a90a4fe7	13
2045038	menthol 1.2 % Topical Gel	SY	d699de4e-f6a8-5255-e053-2a95a90a4fe7	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82551-119-14	82551011914	118 mL in 1 BOTTLE (82551-119-14)	118 ml	2022-01-26	0000-00-00	No	No	Current