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
2026-12-31
Current FDA listing
Yes

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 Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A, 43XOA705ZD
Rxcui311499

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

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