FDA.reportPublic FDA data

Rexall ICE COLD ANALGESIC

Product NDC
55910-088
Requested package NDC
55910-088-08
11-digit product format
559100088
Labeler code
55910
Product ID
55910-088_7769fdbb-be39-7fc6-e053-2991aa0aa088
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Dolgencorp, LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-10-01
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
2 g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage55910-08855910-088-08IInactivated 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 packagepackage55910-08855910-088-08IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55910-08855910-088-08IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…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 conceptRelationVersionEffective
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55910-088-082025-07-29C16284748780-13b156c62-266f-fb37-e063-e6dba90a4e077769ca14-3159-4bfa-e053-2a91aa0a65f1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-088-08Rexall ICE COLD ANALGESIC227 g in 1 JARGEL2271

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-088REXALL ICE COLD ANALGESIC (MENTHOL) GEL [DOLGENCORP, LLC]1Legacy NDC, 1 package rows20181010_7769ca14-3159-4bfa-e053-2a91aa0a65f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311502menthol 2 % Topical GelPSN7769ca14-3159-4bfa-e053-2a91aa0a65f11
311502menthol 0.02 MG/MG Topical GelSCD7769ca14-3159-4bfa-e053-2a91aa0a65f11
311502menthol 2 % Topical GelSY7769ca14-3159-4bfa-e053-2a91aa0a65f11
311502menthol 2 % topical stickSY7769ca14-3159-4bfa-e053-2a91aa0a65f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-088-0855910008808227 g in 1 JAR (55910-088-08) 227 g2018-10-010000-00-00NoNoCurrent