FDA.reportPublic FDA data

BioFlexor

Product NDC
62391-100
Requested package NDC
62391-100-30
11-digit product format
623910100
Labeler code
62391
Product ID
62391-100_edff9018-f1fa-34da-e053-2a95a90a8bed
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Health Care Laboratories Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1998-03-01
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
3 g/100g
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 packagepackage62391-10062391-100-30IInactivated 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
62391-100-022024-07-30BioFlexor Deep Penetrating Gel
62391-100-042024-07-30BioFlexor Deep Penetrating Gel
62391-100-302024-07-30BioFlexor Deep Penetrating Gel
62391-100-022024-01-30BioFlexor Deep Penetrating Gel
62391-100-042024-01-30BioFlexor Deep Penetrating Gel
62391-100-302024-01-30BioFlexor Deep Penetrating Gel
62391-100-022023-12-18BioFlexor Deep Penetrating Gel
62391-100-042023-12-18BioFlexor Deep Penetrating Gel
62391-100-302023-12-18BioFlexor Deep Penetrating Gel
62391-100-022023-07-28BioFlexor Deep Penetrating Gel
62391-100-042023-07-28BioFlexor Deep Penetrating Gel
62391-100-302023-07-28BioFlexor Deep Penetrating Gel
62391-100-022022-12-06BioFlexor Deep Penetrating Gel
62391-100-042022-12-06BioFlexor Deep Penetrating Gel
62391-100-302022-12-06BioFlexor Deep Penetrating Gel
62391-100-022022-07-29BioFlexor Deep Penetrating Gel
62391-100-042022-07-29BioFlexor Deep Penetrating Gel
62391-100-302022-07-29BioFlexor Deep Penetrating Gel
62391-100-022021-11-12BioFlexor Deep Penetrating Gel
62391-100-042021-11-12BioFlexor Deep Penetrating Gel
62391-100-302021-11-12BioFlexor Deep Penetrating Gel
62391-100-022021-07-23BioFlexor Deep Penetrating Gel
62391-100-042021-07-23BioFlexor Deep Penetrating Gel
62391-100-302021-07-23BioFlexor Deep Penetrating Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62391-100-02BioFlexor0467.5 g in 1 JARGEL67.514
62391-100-04BioFlexor04135 g in 1 JARGEL13514
62391-100-30BioFlexor04960 g in 1 JARGEL96014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62391-100BIOFLEXOR 04 (MENTHOL) GEL [HEALTH CARE LABORATORIES INC.]14Legacy NDC, 3 package rows20231219_7f49ad9a-4062-69ee-e053-2a91aa0a6bd5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1304408BioFlexor 3 % Topical GelPSN7f49ad9a-4062-69ee-e053-2a91aa0a6bd514
259150menthol 3 % Topical GelPSN7f49ad9a-4062-69ee-e053-2a91aa0a6bd514
1304408menthol 0.03 MG/MG Topical Gel [Bioflexor]SBD7f49ad9a-4062-69ee-e053-2a91aa0a6bd514
259150menthol 0.03 MG/MG Topical GelSCD7f49ad9a-4062-69ee-e053-2a91aa0a6bd514
1304408Bioflexor 0.03 MG/MG Topical GelSY7f49ad9a-4062-69ee-e053-2a91aa0a6bd514
1304408Bioflexor 3 % Topical GelSY7f49ad9a-4062-69ee-e053-2a91aa0a6bd514
259150menthol 3 % Topical GelSY7f49ad9a-4062-69ee-e053-2a91aa0a6bd514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62391-100-3062391010030960 g in 1 JAR (62391-100-30) 960 g1998-03-010000-00-00NoNoCurrent