FDA.reportPublic FDA data

Therapain Plus

Product NDC
58418-827
11-digit product format
584180827
Labeler code
58418
Product ID
58418-827_4c12906d-43bf-553f-e063-6394a90a6edd
Type
HUMAN OTC DRUG
Nonproprietary name
menthol roll-on
Dosage form
LIQUID
Route
TOPICAL
Labeler
Epic Laboratories, LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-25
Substance
MENTHOL
Active strength
2 g/100mL
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
Therapain Plus
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL2 g/100mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1146695Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0249cfdf-b7c4-f27d-e063-6294a90aaa26Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58418-827-032024-08-22C16284748780-11030e365-340e-111a-e063-dadaa90a10e2Therapain Plus Roll On
58418-827-032024-07-30C16284748780-11030e365-340e-111a-e063-dadaa90a10e2Therapain Plus Roll On
58418-827-032024-01-30C16284748780-11030e365-340e-111a-e063-dadaa90a10e2Therapain Plus Roll On

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58418-827-03Therapain Plus88.5 mL in 1 BOTTLE, DISPENSINGLIQUID88.55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58418-827THERAPAIN PLUS (MENTHOL ROLL-ON) LIQUID [EPIC LABORATORIES, LLC]4Current NDC, 1 package rows20250101_0249cfdf-b7c4-f27d-e063-6294a90aaa26.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 1 of 23 · 441 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flarestop Hemorrhoid LidocaineLIDOCAINEChelsea Pharmacceuticals LLCb8a589f7-7131-4807-9bcb-84af3078e2582026-09-10WarningsExact identifier
application number: M015
BCBCYC Numbing CreamLIDOCAINE 5% NUMBING CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5ab36566-ba2f-06ef-e063-6394a90a71b52026-09-10WarningsExact identifier
application number: M015
5% Lidocaine 10g5% LIDOCAINEChongqing Mandongzi Technology Co., Ltd5b10530f-47cd-c4bd-e063-6294a90aaa0a2026-09-09WarningsExact identifier
application number: M015
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
application number: M015
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
application number: M015
Flushable Hemorrhoidal Medicated Wipes Maximum StrengthWITCH HAZELAmazon.com Services LLC41d756f3-e523-ed14-e063-6394a90ab8172026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
Signature Care Medicated Wipes Hemorrhoidal Wipes with Witch HazelHEMORRHOIDAL WIPES WITH WITCH HAZELBetter Living Brands LLCadf26111-70ba-596c-e053-2995a90ac6f12026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
up and up medicated wipes manixim strengthGENTLE HEMORRHOIDAL CARETarget Corporation271eab2b-ed13-39f1-e054-00144ff88e882026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
KROGER MEDICATED WIPES HEMORRHOIDAL WIPE WITH WITCH HAZEL AND ALOEWITCH HAZEL CLOTHThe Kroger Co.48c1598d-6667-446f-ac90-10ab945d06172026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
Rexall Medicated WipesHemorrhoidal wipe Hemorrhoidal wipes with witch hazelWITCH HAZELOld East Main Co.2055289d-962e-46a9-b371-b5bb93dd46b42026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
Equate Hemorrhoidal Medicated WipesWITCH HAZELWalmart Inc.8d57f054-77dc-4205-85f1-b65dcfde677b2026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
Lidocaine CreamLIDOCAINEInvaDerm Corporation5a7273d1-1dbc-420e-e063-6294a90a86292026-09-01WarningsExact identifier
application number: M015
Lidocaine PhenylephrineLIDOCAINE PHENYLEPHRINEYYBA CORP5a72a190-2129-411e-e063-6394a90a08c22026-09-01WarningsExact identifier
application number: M015
INICEI 5% LIDOCAINE Numbing Cream5% LIDOCAINE NUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5a65842f-27a1-268b-e063-6294a90a60542026-08-31WarningsExact identifier
application number: M015
AnievaLCLIDOCAINEBlackstone Products, LLCddaba14c-10de-44e2-ae13-9217e20cb48e2026-08-29WarningsExact identifier
application number: M015
Norms Hemorrhoid WipesWITCH HAZELTotally Normal Company5a1af50b-8d00-f589-e063-6394a90af86c2026-08-28WarningsExact identifier
application number: M015
LAIYINHE Numbing Cream Anorectal (Hemorrhoidal) CreamLIDOCAINEGuangzhou Hechuang Commercial Service Co.,Ltd.59f0fa16-5eb0-e6bb-e063-6294a90aacf52026-08-26WarningsExact identifier
application number: M015
Dude Hemorrhoidal WipesWITCH HAZELDude Productsfdf408ef-9392-a812-e053-6394a90a00172026-08-25WarningsExact identifier
application number: M015
Norms Medicated WipesWITCH HAZELTotally Normal Company3a78e109-3f7c-fb19-e063-6394a90ae78e2026-08-22WarningsExact identifier
application number: M015
Lidocaine Numbing CreamLIDOCAINEShanghai Chuangshi Medical Technology (Group) Co., Ltd.599b425a-0e96-76df-e063-6394a90a48ff2026-08-21WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1146695menthol 2 % Topical SolutionPSN0249cfdf-b7c4-f27d-e063-6294a90aaa265
1146695menthol 20 MG/ML Topical SolutionSCD0249cfdf-b7c4-f27d-e063-6294a90aaa265
1146695menthol 2 % Topical SolutionSY0249cfdf-b7c4-f27d-e063-6294a90aaa265

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58418-827-035841808270388.5 mL in 1 BOTTLE, DISPENSING (58418-827-03) 88.5 ml2023-08-25NoNoCurrent