FDA.reportPublic FDA data

Xpect Stopain Clinical

Product NDC
42961-256
11-digit product format
429610256
Labeler code
42961
Product ID
42961-256_17811bf5-a21f-422a-9506-4b689894974f
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Cintas Corporation
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-14
Substance
MENTHOL
Active strength
100 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Xpect Stopain Clinical
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL100 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
259249Internal RxNorm lookup
1865942Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
348e6062-b31e-435e-a153-6aa868b50efaAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42961-256-01Xpect Stopain Clinical3 g in 1 PACKETGEL34
42961-256-02Xpect Stopain Clinical5 in 1 BAGGEL54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42961-256XPECT STOPAIN CLINICAL (MENTHOL) GEL [CINTAS CORPORATION]1Current NDC, 2 package rows20240616_348e6062-b31e-435e-a153-6aa868b50efa.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 43 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BLT 2LIDOCAINE HCLCENTURA PHARMACEUTICALS INC41dc85ec-d79b-0a32-e054-00144ff8d46c2026-01-12WarningsExact identifier
application number: M017
Mineral Ice Pain RelievingMENTHOLCrown Laboratories7b30076a-0af6-2f74-e053-2a91aa0ae08d2026-01-12WarningsExact identifier
application number: M017
SarnaPRAMOXINE HYDROCHLORIDECrown Laboratories19b0ce1b-e147-01a1-e063-6394a90af8082026-01-12WarningsExact identifier
application number: M017
SarnaPRAMOXINE HYDROCHLORIDE, MENTHOLCrown Laboratories, Inc19c41e75-a654-90cf-e063-6394a90a7e972026-01-12WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEHY-VEE, INC48350b54-8d9a-48c4-e063-6394a90ac0402026-01-12WarningsExact identifier
application number: M017
LidoPlus Pain ReliefLIDOCAINE HYDROCHLORIDECentura Pharmaceuticals, Inc07bacc6c-60a6-4297-8663-904a22bdc0402026-01-12WarningsExact identifier
application number: M017
BlueStop MaxEXTERNAL ANALGESICClavel Corporationf1efb51c-5217-4cb2-e053-2a95a90a7f952026-01-12WarningsExact identifier
application number: M017
BlueStop MaxEXTERNAL ANALGESICClavel Corporationf2277e27-868b-57ef-e053-2a95a90abf282026-01-12WarningsExact identifier
application number: M017
BLT 3TETRACAINECENTURA PHARMACEUTICALS INC401a0d22-1181-02ac-e054-00144ff88e882026-01-12WarningsExact identifier
application number: M017
Sting Relief Prep PadBENZOCAINENINGBO TIANBO FIRST AID PRODUCT CO., LTD.0c901f64-6890-45c0-9ca7-ee9de87903c42026-01-12WarningsExact identifier
application number: M017
Goodsense Oral Pain ReliefBENZOCAINEGeiss, Destin and Dunn, Inc.eb461b70-d10f-4e11-8374-e43713f3504d2026-01-12WarningsExact identifier
application number: M017
Extra Strength BalmCAPSICUM AND MENTHOLSaje Natural Business Incf516e416-446b-8f21-e053-2a95a90afd882026-01-12WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.3df0e56a-7651-42dc-8ed8-f68836a63c612026-01-12WarningsExact identifier
application number: M017
Trauma LessMENTHOLSaje Natural Business Inc.650cba4c-6aba-48c3-9c41-841f199055482026-01-12WarningsExact identifier
application number: M017
MamisanLIDOCAINE HYDROCHLORIDE, MENTHOLMiramar Cosmetics, Inc DBA Miramar Lab4402e900-c6e9-4f32-8cc4-c84014384a9f2026-01-12WarningsExact identifier
application number: M017
Curist Lidocaine PatchLIDOCAINE 4% PATCHLittle Pharma, Inc.1a8fe44e-7a21-c2ab-e063-6394a90a61002026-01-11WarningsExact identifier
application number: M017
DG Health Pain RelievingLIDOCAINE HCLDOLGENCORP, LLC923aeb4c-049f-4ecc-a77e-9ffa0e236d4e2026-01-11WarningsExact identifier
application number: M017
Campho-Phenique AntisepticCAMPHOR (SYNTHETIC) AND PHENOLFoundation Consumer Healthcare46b84e0b-78a9-4cde-9f90-e165b54191622026-01-09WarningsExact identifier
application number: M017
MyDerm Pro Freeze Cooling Menthol Pain Relief Roll-OnMENTHOLInspec Solutions12ff9b9a-73e5-ce31-e063-6294a90aeaf82026-01-09WarningsExact identifier
application number: M017
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.bb0278c9-eaff-d435-e053-2995a90a202a2026-01-09WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259249menthol 10 % Topical GelPSN348e6062-b31e-435e-a153-6aa868b50efa4
1865942Stopain CLINICAL 10 % Topical GelPSN348e6062-b31e-435e-a153-6aa868b50efa4
1865942menthol 0.1 MG/MG Topical Gel [Stopain]SBD348e6062-b31e-435e-a153-6aa868b50efa4
259249menthol 0.1 MG/MG Topical GelSCD348e6062-b31e-435e-a153-6aa868b50efa4
259249menthol 10 % Topical GelSY348e6062-b31e-435e-a153-6aa868b50efa4
1865942Stopain 0.1 MG/MG Topical GelSY348e6062-b31e-435e-a153-6aa868b50efa4
1865942Stopain 10 % Topical GelSY348e6062-b31e-435e-a153-6aa868b50efa4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42961-256-01429610256013 g in 1 PACKET (42961-256-01) 3 g2025-07-30NoNoCurrent
42961-256-02429610256025 PACKET in 1 BAG (42961-256-02) / 3 g in 1 PACKET (42961-256-01) 5 packet2025-07-30NoNoCurrent