FDA.reportPublic FDA data

Rite Aid Hot and Cold Pain Relief

Product NDC
11822-4216
Requested package NDC
11822-4216-1
11-digit product format
118224216
Labeler code
11822
Product ID
11822-4216_e08e67d9-8e88-63a5-e053-2995a90ae9ee
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine HCl and Menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
Rite Aid
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-06-01
Marketing end
0000-00-00
Substance
LIDOCAINE; MENTHOL
Active strength
0 g/g; g/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11822-421611822-4216-1IInactivated by FDA2026-10-05

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11822-421611822-4216-1IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11822-421611822-4216-1IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-4216-12025-07-29C16284748780-13b156c62-313f-fb37-e063-e6dba90a4e07Rite Aid Hot & Cold Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-4216-1Rite Aid Hot and Cold Pain ReliefPain Relieving1 in 1 CARTONCREAM12
11822-4216-1Rite Aid Hot and Cold Pain ReliefPain Relieving76.5 g in 1 TUBECREAM76.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-4216RITE AID HOT AND COLD PAIN RELIEF PAIN RELIEVING (LIDOCAINE HCL AND MENTHOL) CREAM [RITE AID]2Legacy NDC, 2 package rows20241220_e08e7c5b-34ba-da8a-e053-2a95a90af497.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
250912lidocaine 4 % / menthol 1 % Topical CreamPSNe08e7c5b-34ba-da8a-e053-2a95a90af4972
250912lidocaine 40 MG/ML / menthol 10 MG/ML Topical CreamSCDe08e7c5b-34ba-da8a-e053-2a95a90af4972
250912lidocaine 4 % / menthol 1 % Topical CreamSYe08e7c5b-34ba-da8a-e053-2a95a90af4972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-4216-1118224216011 TUBE in 1 CARTON (11822-4216-1) > 76.5 g in 1 TUBE1 tube2022-06-010000-00-00NoNoCurrent