FDA.reportPublic FDA data

Flexall Pain Relieving

Product NDC
63187-107
11-digit product format
631870107
Labeler code
63187
Product ID
63187-107_72d9021b-a7bf-4043-a505-9142bf00301b
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Proficient Rx LP
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1997-01-01
Marketing end
0000-00-00
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
0 g/g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63187-107DDiscontinued by firm2026-10-05
excluded packagepackage63187-10763187-107-03DDiscontinued by firm2026-10-05

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-107-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-107-03f5e01cc5f278…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
63187-107-032019-12-04C16284748780-19855e2a2-39e1-60a7-e053-dbdaa90a05bdFlexall Max
63187-107-032019-11-27C16284748780-19855e2a2-39e1-60a7-e053-dbdaa90a05bdFlexall Max

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AFLEXALL PAIN RELIEVING (MENTHOL) GEL [PROFICIENT RX LP]1
MENTHOLACTIVE MOIETYL7T10EIP3AFLEXALL PAIN RELIEVING (MENTHOL) GEL [PROFICIENT RX LP]1
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4NFLEXALL PAIN RELIEVING (MENTHOL) GEL [PROFICIENT RX LP]1
ALLANTOININACTIVE INGREDIENT344S277G0ZFLEXALL PAIN RELIEVING (MENTHOL) GEL [PROFICIENT RX LP]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XFLEXALL PAIN RELIEVING (MENTHOL) GEL [PROFICIENT RX LP]1
CORYMBIA CITRIODORA LEAF OILINACTIVE INGREDIENTM63U6N96EBFLEXALL PAIN RELIEVING (MENTHOL) GEL [PROFICIENT RX LP]1
DIISOPROPYL ADIPATEINACTIVE INGREDIENTP7E6YFV72XFLEXALL PAIN RELIEVING (MENTHOL) GEL [PROFICIENT RX LP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFLEXALL PAIN RELIEVING (MENTHOL) GEL [PROFICIENT RX LP]1
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YFLEXALL PAIN RELIEVING (MENTHOL) GEL [PROFICIENT RX LP]1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHFLEXALL PAIN RELIEVING (MENTHOL) GEL [PROFICIENT RX LP]1
STEARETH-2INACTIVE INGREDIENTV56DFE46J5FLEXALL PAIN RELIEVING (MENTHOL) GEL [PROFICIENT RX LP]1
STEARETH-21INACTIVE INGREDIENT53J3F32P58FLEXALL PAIN RELIEVING (MENTHOL) GEL [PROFICIENT RX LP]1
THYME OILINACTIVE INGREDIENT2UK410MY6BFLEXALL PAIN RELIEVING (MENTHOL) GEL [PROFICIENT RX LP]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKFLEXALL PAIN RELIEVING (MENTHOL) GEL [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RFLEXALL PAIN RELIEVING (MENTHOL) GEL [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-107FLEXALL PAIN RELIEVING (MENTHOL) GEL [PROFICIENT RX LP]3Legacy NDC20231212_3590f862-1148-4e8e-ad8a-aa8abc8945af.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-107-03631870107031 TUBE in 1 CARTON (63187-107-03) > 85 g in 1 TUBE1 tube2014-07-010000-00-00NoNoCurrent