FDA.reportPublic FDA data

Theracare Ice Blue Gel

Product NDC
71101-217
Requested package NDC
71101-217-01
11-digit product format
711010217
Labeler code
71101
Product ID
71101-217_d61eb82f-782c-e08b-e053-2a95a90a10ff
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Veridian Healthcare
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-01-01
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
20 mg/g
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 packagepackage71101-21771101-217-01IInactivated 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 packagepackage71101-21771101-217-01IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71101-21771101-217-01IInactivated 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
71101-217-012025-07-29C16284748780-13b156c62-2cc1-fb37-e063-e6dba90a4e07Theracare Ice Blue Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71101-217-01Theracare Ice Blue GelPain Relieving226.8 g in 1 JARGEL226.83

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71101-217THERACARE ICE BLUE GEL PAIN RELIEVING (MENTHOL) GEL [VERIDIAN HEALTHCARE]3Legacy NDC, 1 package rows20241220_d61eb82f-782b-e08b-e053-2a95a90a10ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311502menthol 2 % Topical GelPSNd61eb82f-782b-e08b-e053-2a95a90a10ff3
311502menthol 0.02 MG/MG Topical GelSCDd61eb82f-782b-e08b-e053-2a95a90a10ff3
311502menthol 2 % Topical GelSYd61eb82f-782b-e08b-e053-2a95a90a10ff3
311502menthol 2 % topical stickSYd61eb82f-782b-e08b-e053-2a95a90a10ff3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71101-217-0171101021701226.8 g in 1 JAR (71101-217-01) 226.8 g2022-01-010000-00-00NoNoCurrent