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 12 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Numb cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3d2ecb86-6bb1-2528-e063-6394a90a8d892025-08-25WarningsExact identifier
application number: M015
Cooling Perineal Pad LinersCOOLING PERINEALELEEO BRANDS LLC29a433bc-a833-ffc7-e063-6294a90a465a2025-08-25WarningsExact identifier
application number: M015
Signature numbing cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3d3b771f-5e30-b23e-e063-6294a90a3fb22025-08-25WarningsExact identifier
application number: M015
Exchange Select HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLArmy & Air Force Exchange Service6c32af3e-5b60-4e3e-95c2-ada37a7d3b2a2025-08-22WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLPadagis Israel Pharmaceuticals Ltd43826c68-0a20-460d-a7b5-f3e12395a7d02025-08-22WarningsExact identifier
application number: M015
Barrier Protectant CreamBARRIER CREAMCardinal Health539d9aac-75cf-4efd-bb3e-b465563304ca2025-08-21WarningsExact identifier
application number: M015
Lidocaine PatchLIDOCAINE 4%SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS0a31ba9a-8283-4bf8-b6c6-6e331465622f2025-08-20WarningsExact identifier
application number: M015
VBBV Anorectal(Hemorrhoidal) CreamsLIDOCAINEJiashen International Trading Co., Ltd.3cba84ea-5ee0-7ee3-e063-6294a90af11b2025-08-19WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLPublix Super Markets Inc7b360d3b-fb2b-4f35-a04d-203dd352933d2025-08-19WarningsExact identifier
application number: M015
Good Sense HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLL. Perrigo Company2492ee1b-01f1-46e7-8790-b6ebc48f2aff2025-08-19WarningsExact identifier
application number: M015
Norms HemorrhoidPHENYLEPHRINE HYDROCHLORIDE, WITCH HAZELTotally Normal Company3c98cc12-2476-9f73-e063-6394a90a6f232025-08-17WarningsExact identifier
application number: M015
Upside Down Pain ReliefBENZOCAINE, GLYCERINFridababy, LLC31c2cd25-1fec-5ec5-e063-6394a90a24b42025-08-15WarningsExact identifier
application number: M015
DG Health HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLDolgencorp, LLCd9f12a34-7bd1-4ba5-b34b-1b641f58271a2025-08-12WarningsExact identifier
application number: M015
Norms HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLTotally Normal Company3bdf8c74-3db6-1805-e063-6394a90aaba02025-08-08WarningsExact identifier
application number: M015
AsteroidMENTHOL, PETROLATUM, ZINC OXIDEHEALTHTEX LIMITED29d1e46d-0189-4f9e-9963-8a9de2757f282025-07-30WarningsExact identifier
application number: M015
Comfort Candy HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEBOWLER ESTHETICS, INC4951d984-3e86-4eb6-9505-2c506e22fda22025-07-23WarningsExact identifier
application number: M015
Doctor Butler Hemorrhoid and Fissure Advanced FormulaGLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5%Beyond Health, PAd2a769e2-afd0-aed2-e053-2995a90ad4292025-07-23WarningsExact identifier
application number: M015
Dr Butlers HemorrhoidWITCH HAZEL 50%Beyond Health, PA3a9fea0c-b189-c77e-e063-6294a90a05832025-07-23WarningsExact identifier
application number: M015
Dr Butlers Advanced Hemorrhoid ReliefLIDOCAINE HCL 5%, PHENYLEPHRINE HCL 0.25%, WITCH HAZEL 50%Beyond Health. PA3aa0ee7a-3863-254d-e063-6394a90ad40e2025-07-23WarningsExact identifier
application number: M015
Dr. Butler Hemorrhoid TreatmentPHENYLEPHRINE HYDROCHLORIDE 0.25%, WITCH HAZEL 50%Beyond Health P.A.d2d1c81c-6443-c4b7-e053-2995a90a14d72025-07-22WarningsExact 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