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
Ingredient	Strength
MENTHOL	2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
0249cfdf-b7c4-f27d-e063-6294a90aaa26	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58418-827-03	2024-08-22	C162847	48780-1	1030e365-340e-111a-e063-dadaa90a10e2	Therapain Plus Roll On
58418-827-03	2024-07-30	C162847	48780-1	1030e365-340e-111a-e063-dadaa90a10e2	Therapain Plus Roll On
58418-827-03	2024-01-30	C162847	48780-1	1030e365-340e-111a-e063-dadaa90a10e2	Therapain Plus Roll On

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58418-827-03	Therapain Plus	88.5 mL in 1 BOTTLE, DISPENSING	LIQUID	88.5		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58418-827	THERAPAIN PLUS (MENTHOL ROLL-ON) LIQUID [EPIC LABORATORIES, LLC]	4	Current NDC, 1 package rows	20250101_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 4 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HEMORRHOIDAL	MINERAL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY, INC	93482a9b-145b-42d4-96db-599c281a39f1	2026-06-10	Warnings	Exact identifier application number: M015
Oudetas Lidocaine Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	53f11395-f460-943f-e063-6294a90affef	2026-06-10	Warnings	Exact identifier application number: M015
Terramed Just Think Comfort Hemorrhoidal Wipes	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	Rida LLC	f6ad00e7-c7b8-40b8-80c2-6e6bf85098b3	2026-06-08	Warnings	Exact identifier application number: M015
Witch Hazel	WITCH HAZEL	CVS Pharmacy, Inc.	50f920da-b41a-480d-b3a0-df940caaee2d	2026-06-08	Warnings, Adverse reactions	Exact identifier application number: M015
Adellina Lidocaine Numbing Cream Topical Anorectal Cream	LIDOCAINE	Guangdong Aimu Biological Technology Co., Ltd	5356cf53-935d-a02f-e063-6394a90a6e5a	2026-06-05	Warnings	Exact identifier application number: M015
Hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	HyVee Inc	b867f691-7a13-4659-b664-06aa36899310	2026-06-03	Warnings	Exact identifier application number: M015
Healcome Lidocaine Numbing Cream	LIDOCAINE	YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD	9b4eac02-1b1f-4630-92b4-b1d8c21abab5	2026-05-29	Warnings	Exact identifier application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash Lavender and chamomile	TOLNAFTATE	Rida LLC	5517c43f-03b2-499a-a217-d9cba3fb9fd2	2026-05-27	Warnings	Exact identifier application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash Citrus	TOLNAFTATE	Rida LLC	b4c5da66-5928-4352-ab90-fd46039e7955	2026-05-27	Warnings	Exact identifier application number: M015
Terramed Just Think Comfort GynoCare BV Guard Intimate Wipes	PRAMOXINE HYDROCHLORIDE	Rida LLC	bb29f156-37b8-400e-802b-3e2671cb7dc8	2026-05-27	Warnings	Exact identifier application number: M015
myDerm MEDICAL NEW Soothing Hemorrhoidal	WITCH HAZEL PENYLEPHRINE LIDOCAINE	Inspec Solutions	2ff42501-7730-42de-99dd-6fc53bbdf25f	2026-05-27	Warnings	Exact identifier application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash Icy Cool Menthol	TOLNAFTATE	Rida LLC	8b15cb3b-f7cb-4a80-94b2-eeeafc9794e8	2026-05-27	Warnings	Exact identifier application number: M015
Lidocaine Roll-on	LIDOCAINE	YYBA Corp	52d060df-2095-dd68-e063-6394a90a7740	2026-05-27	Warnings	Exact identifier application number: M015
PUVIDA NUMBING Cream Anorectal (Hemorrhoidal) Cream	LIDOCAINE 5% NUMBING CREAM ANORECTAL (HEMORRHOIDAL) CREAM	Jiangxi Yudexi Pharmaceutical Co., LTD	52a25b97-7721-6410-e063-6394a90a228f	2026-05-25	Warnings	Exact identifier application number: M015
Arlun LIDOCAINE Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5241c26b-6c91-65a5-e063-6394a90a2477	2026-05-20	Warnings	Exact identifier application number: M015
tuiwaro LIDOCAINE Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5223b7fe-6aba-c77b-e063-6394a90ad27b	2026-05-18	Warnings	Exact identifier application number: M015
HEMORRHOIDAL WITH LIDOCAINE	GLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUM	CVS PHARMACY, INC	4d870c68-9e72-464e-b0b8-900d0d661e43	2026-05-14	Warnings	Exact identifier application number: M015
Oxify	LIDOCAINE 5%	Weeks & Leo Compnay, INC.	51cd58f7-c1c9-f4e2-e063-6294a90ad970	2026-05-14	Warnings	Exact identifier application number: M015
Lidocaine anorectal cream	LIDOCAINE 5%	EveryMarket Inc	1604daec-812f-4684-ba98-fbcda07a7461	2026-05-12	Warnings	Exact identifier application number: M015
PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES	WITCH HAZEL	Haleon US Holdings LLC	485437a8-b2e9-4acf-a20e-edb1f08a9cae	2026-05-11	Warnings	Exact identifier application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1146695	menthol 2 % Topical Solution	PSN	0249cfdf-b7c4-f27d-e063-6294a90aaa26	5
1146695	menthol 20 MG/ML Topical Solution	SCD	0249cfdf-b7c4-f27d-e063-6294a90aaa26	5
1146695	menthol 2 % Topical Solution	SY	0249cfdf-b7c4-f27d-e063-6294a90aaa26	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
58418-827-03	58418082703	88.5 mL in 1 BOTTLE, DISPENSING (58418-827-03)	88.5 ml	2023-08-25	No	No	Current