Army Health Pain Reliever

Product NDC
53174-000
11-digit product format
531740000
Labeler code
53174
Product ID
53174-000_b69ae790-45f8-38e5-e053-2a95a90aad02
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Cas Group International
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-08-24
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
30 mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct53174-000DDiscontinued by firm2026-10-15
excluded packagepackage53174-00053174-000-04DDiscontinued by firm2026-10-15

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 · 24 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 packagepackage53174-000-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53174-000-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53174-000-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53174-000-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53174-000-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53174-000-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53174-000-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53174-000-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53174-000-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53174-000-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53174-000-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53174-000-04557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AARMY HEALTH PAIN RELIEVER (MENTHOL) GEL [CAS GROUP INTERNATIONAL]2
MENTHOLACTIVE MOIETYL7T10EIP3AARMY HEALTH PAIN RELIEVER (MENTHOL) GEL [CAS GROUP INTERNATIONAL]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ARMY HEALTH PAIN RELIEVER (MENTHOL) GEL [CAS GROUP INTERNATIONAL]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XARMY HEALTH PAIN RELIEVER (MENTHOL) GEL [CAS GROUP INTERNATIONAL]2
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZARMY HEALTH PAIN RELIEVER (MENTHOL) GEL [CAS GROUP INTERNATIONAL]2
BROMELAINSINACTIVE INGREDIENTU182GP2CF3ARMY HEALTH PAIN RELIEVER (MENTHOL) GEL [CAS GROUP INTERNATIONAL]2
CAPSAICININACTIVE INGREDIENTS07O44R1ZMARMY HEALTH PAIN RELIEVER (MENTHOL) GEL [CAS GROUP INTERNATIONAL]2
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FTARMY HEALTH PAIN RELIEVER (MENTHOL) GEL [CAS GROUP INTERNATIONAL]2
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUARMY HEALTH PAIN RELIEVER (MENTHOL) GEL [CAS GROUP INTERNATIONAL]2
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662ARMY HEALTH PAIN RELIEVER (MENTHOL) GEL [CAS GROUP INTERNATIONAL]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDARMY HEALTH PAIN RELIEVER (MENTHOL) GEL [CAS GROUP INTERNATIONAL]2
GLUCOSAMINE SULFATEINACTIVE INGREDIENT1FW7WLR731ARMY HEALTH PAIN RELIEVER (MENTHOL) GEL [CAS GROUP INTERNATIONAL]2
HORSE CHESTNUTINACTIVE INGREDIENT3C18L6RJAZARMY HEALTH PAIN RELIEVER (MENTHOL) GEL [CAS GROUP INTERNATIONAL]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ARMY HEALTH PAIN RELIEVER (MENTHOL) GEL [CAS GROUP INTERNATIONAL]2
MATRICARIA RECUTITAINACTIVE INGREDIENTG0R4UBI2ZZARMY HEALTH PAIN RELIEVER (MENTHOL) GEL [CAS GROUP INTERNATIONAL]2
MELISSA OFFICINALISINACTIVE INGREDIENTYF70189L0NARMY HEALTH PAIN RELIEVER (MENTHOL) GEL [CAS GROUP INTERNATIONAL]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TARMY HEALTH PAIN RELIEVER (MENTHOL) GEL [CAS GROUP INTERNATIONAL]2
ROSEMARYINACTIVE INGREDIENTIJ67X351P9ARMY HEALTH PAIN RELIEVER (MENTHOL) GEL [CAS GROUP INTERNATIONAL]2
SALIX ALBA BARKINACTIVE INGREDIENT205MXS71H7ARMY HEALTH PAIN RELIEVER (MENTHOL) GEL [CAS GROUP INTERNATIONAL]2
TILIA CORDATA FLOWERINACTIVE INGREDIENTCFN6G1F6YKARMY HEALTH PAIN RELIEVER (MENTHOL) GEL [CAS GROUP INTERNATIONAL]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKARMY HEALTH PAIN RELIEVER (MENTHOL) GEL [CAS GROUP INTERNATIONAL]2
WATERINACTIVE INGREDIENT059QF0KO0RARMY HEALTH PAIN RELIEVER (MENTHOL) GEL [CAS GROUP INTERNATIONAL]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53174-000-0453174000004120 mL in 1 TUBE (53174-000-04) 120 ml2017-02-220000-00-00NoNoCurrent