Rite Aid Cool Therapy Gel

Product NDC: 11822-4217
Requested package NDC: 11822-4217-1
11-digit product format: 118224217
Labeler code: 11822
Product ID: 11822-4217_dfed13d5-8af0-7f07-e053-2a95a90a389e
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Rite Aid
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2022-05-01
Marketing end: 0000-00-00
Substance: MENTHOL
Active strength: 40 mg/mL
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	11822-4217	11822-4217-1	I	Inactivated by FDA		2026-10-15

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 · 8 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11822-4217-1	2025-07-29	C162847	48780-1	1030e365-3c57-111a-e063-dadaa90a10e2	Rite Aid Cool Therapy Gel
11822-4217-1	2024-12-19	C162847	48780-1	1030e365-3c57-111a-e063-dadaa90a10e2	Rite Aid Cool Therapy Gel
11822-4217-1	2024-01-30	C162847	48780-1	1030e365-3c57-111a-e063-dadaa90a10e2	Rite Aid Cool Therapy Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11822-4217-1	Rite Aid Cool Therapy Gel	88.72 mL in 1 BOTTLE	GEL	88.72		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11822-4217	RITE AID COOL THERAPY GEL (MENTHOL) GEL [RITE AID]	2	Legacy NDC, 1 package rows	20241222_dfed135a-b55e-93d6-e053-2a95a90a90d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
415974	menthol 4 % Topical Gel	PSN	dfed135a-b55e-93d6-e053-2a95a90a90d6	2
415974	menthol 0.04 MG/MG Topical Gel	SCD	dfed135a-b55e-93d6-e053-2a95a90a90d6	2
415974	menthol 4 % Topical Gel	SY	dfed135a-b55e-93d6-e053-2a95a90a90d6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11822-4217-1	11822421701	88.72 mL in 1 BOTTLE (11822-4217-1)	88.72 ml	2022-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rite Aid Cool Therapy Gel	Rite Aid \| Anicare Pharmaceuticals Pvt. Ltd.	2024-12-19	HUMAN OTC DRUG LABEL	2