FDA.reportPublic FDA data

TheraPlus

Product NDC
55621-004
11-digit product format
556210004
Labeler code
55621
Product ID
55621-004_08831525-5717-3c3d-e063-6394a90a5aed
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Zhejiang Jingwei Pharmaceutical Co., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-03-01
Substance
MENTHOL; MENTHYL SALICYLATE, (+/-)-
Active strength
10; 15 g/100g; g/100g
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
TheraPlus
Brand name suffix
Plus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL10 g/100g
MENTHYL SALICYLATE, (+/-)-15 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
43XOA705ZDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311499Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d4119f84-eb60-4134-b58e-de13d9601199Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55621-004-01TheraPlus Plus28 g in 1 TUBEOINTMENT286

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ATHERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]4
MENTHYL SALICYLATE, (+/-)-ACTIVE INGREDIENT43XOA705ZDTHERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]4
MENTHOLACTIVE MOIETYL7T10EIP3ATHERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]4
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZTHERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]4
LAURETH-23INACTIVE INGREDIENTN72LMW566GTHERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTHERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]4
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPTHERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3THERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTHERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTHERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]4
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YTHERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]4
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKTHERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]4
WATERINACTIVE INGREDIENT059QF0KO0RTHERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55621-004THERAPLUS PLUS (MENTHOL) OINTMENT [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]6Current NDC, Legacy NDC, 1 package rows20231025_d4119f84-eb60-4134-b58e-de13d9601199.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 20 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stud 100 Male Genital DesensitizerLIDOCAINEPound International Corpd075656e-b13f-4a1d-bbb6-501e642698d52026-05-12WarningsExact identifier
application number: M017
CeraVe Developed with Dermatologists Itch Relief MoisturizingPRAMOXINE HYDROCHLORIDEL'Oreal USA Products Inc13ce57d0-b1c5-4685-ad7d-a562d9d8fc862026-05-12WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYCVS Pharmacydb6f518d-3a0e-43f8-8d19-7382d9b7ff1c2026-05-11WarningsExact identifier
application number: M017
Cool and HeatMENTHOLAMERISOURCE BERGENf2bb0e8e-c4cd-0e8c-e053-2995a90a6df72026-05-11WarningsExact identifier
application number: M017
Instaflex Extra Strength Pain Relief CreamMENTHOL, METHYL SALICYLATEHealthy Directions, LLCd058c64d-0e4f-45aa-8f52-804961b562e32026-05-11WarningsExact identifier
application number: M017
BonicaEaseX Hot Capsicum Pain RelievingCAPSICUMPlanet (Anhui) Pharmaceutical Co.,Ltdca6e48af-af6d-4808-a576-0319d2080d382026-05-11WarningsExact identifier
application number: M017
BonicaEaseX Pain Relieving LidocaineLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.7486fe89-a377-4a37-997d-e3bd16b891a72026-05-11WarningsExact identifier
application number: M017
YYSDMVY NUMBING CreamLIDOCAINE 4% NUMBING CREAMJiangxi Yudexi Pharmaceutical Co., LTD5195f5ec-8524-77f5-e063-6294a90abdc22026-05-11WarningsExact identifier
application number: M017
Lightning X Burn Relief GelLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.515eb4cc-63af-c11d-e063-6294a90a13ca2026-05-09WarningsExact identifier
application number: M017
Albertson Lidocaine, Menthol Pain Relief Medicated PatchLIDOCAINE AND MENTHOLSafewaydc647647-90ec-6beb-e053-2a95a90a79822026-05-09WarningsExact identifier
application number: M017
5 Elementum Lidocaine Male Genital DesensitizerLIDOCAINE MALE GENITAL DESENSITIZERMSVENTURESGROUP O514b1738-886e-a95d-e063-6294a90aa7072026-05-08WarningsExact identifier
application number: M017
Kroger Muscle Rub CreamMENTHOL, CAMPHOR, METHYL SALICYLATEKroger Co.45c8c79a-b4b4-d4be-e063-6394a90a92512026-05-08WarningsExact identifier
application number: M017
Walmart Equate Aloe Sunburn Relief CoolingLIDOCAINEWAL-MART STORES INC.51540f6b-596f-bc47-e063-6294a90a46ae2026-05-08WarningsExact identifier
application number: M017
Capsaicin 0.035% creamCAPSAICINMedcore LLC0236e1e4-c26c-4fff-a83b-143ce26d93bf2026-05-07WarningsExact identifier
application number: M017
Lidocaine 4% CreamLIDOCAINEMedcore LLC111cb421-ba3b-4772-ab60-d31eb41831682026-05-07WarningsExact identifier
application number: M017
Lidocaine 5% CreamLIDOCAINEMedcore LLC15d02b42-bf8b-486a-a081-f6d17cc11ec72026-05-07WarningsExact identifier
application number: M017
JenGufun LIDOCAINE Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Kangdi Medical Devices Co., Ltd.51363a41-5dcc-6a3b-e063-6294a90a6c272026-05-07WarningsExact identifier
application number: M017
LidoxiLIDOCAINET&T Pharma Holdings LLC513c517e-c098-02aa-e063-6294a90ac8a42026-05-07WarningsExact identifier
application number: M017
Harris Teeter HydrocortisoneHYDROCORTISONEHARRIS TEETER LLC4e8199f8-96ec-5342-e063-6294a90afb2d2026-05-07WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Inc.5114cdba-96a1-c399-e063-6294a90aac122026-05-06WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311499menthol 10 % / methyl salicylate 15 % Topical OintmentPSNd4119f84-eb60-4134-b58e-de13d96011996
311499menthol 0.1 MG/MG / methyl salicylate 0.15 MG/MG Topical OintmentSCDd4119f84-eb60-4134-b58e-de13d96011996
311499menthol 10 % / methyl salicylate 15 % Topical OintmentSYd4119f84-eb60-4134-b58e-de13d96011996

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55621-004-015562100040128 g in 1 TUBE (55621-004-01) 28 g2013-03-010000-00-00NoNoCurrent