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

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 18 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biofreeze Overnight Roll-onMENTHOLReckitt Benckiser LLCf67d7b7a-8922-73f6-e053-2995a90a2e802026-05-15WarningsExact identifier
application number: M017
Biofreeze Overnight ReliefMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC07be6e88-1850-4d6a-946d-f03830b8c4a22026-05-15WarningsExact identifier
application number: M017
Biofreeze Roll-On and Overnight Roll-OnMENTHOLReckitt Benckiser LLC4d3dcb8f-2075-6bbc-e063-6394a90a49922026-05-15WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC6bef9ccb-7a5a-4c67-b1bc-a92b167312da2026-05-15WarningsExact identifier
application number: M017
Biofreeze Roll-OnMENTHOLReckitt Benckiser LLCebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb2026-05-15WarningsExact identifier
application number: M017
Biofreeze Precision Relief PenMENTHOLReckitt Benckiser LLCb4cc1db5-a33f-17bc-e053-2995a90ab7eb2026-05-15WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCdb982baf-31ea-4f09-90e3-cd5facb5dfe52026-05-15WarningsExact identifier
application number: M017
Biofreeze Professional Roll-OnMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCf62f8ec3-593d-480a-85a0-01fcd7f1790c2026-05-15WarningsExact identifier
application number: M017
PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ONMENTHOLReckitt Benckiser LLC8af185ad-719e-4684-89c0-9c17c12774992026-05-15WarningsExact identifier
application number: M017
PERFORM COOL and SOOTHING PAIN RELIEVINGMENTHOLReckitt Benckiser LLCef158f63-2d75-47a3-b94a-2d821d5118632026-05-15WarningsExact identifier
application number: M017
KY Duration for HimLIDOCAINEReckitt Benckiser LLC83cc86bd-3303-4956-a198-fae85b6e34e12026-05-15WarningsExact identifier
application number: M017
4% LIDOCAINE PATCHES4% LIDOCAINEShenzhen Huayuan Hengsheng Technology Co., Ltd.4f53cfd3-a7c4-e308-e063-6294a90ad6982026-05-14WarningsExact identifier
application number: M017
Cold and Heat Lidocaine Patch Plus MentholLIDOCAINE, MENTHOLCardinal Health, 110 dba LEADER77066d01-75b0-4a8d-88d3-c639626d33262026-05-14WarningsExact identifier
application number: M017
Pain Relief Gel-Roll OnLIDOCAINETrifecta Pharmaceuticals USA51cb6797-55ec-7a7a-e063-6294a90a90ee2026-05-14WarningsExact identifier
application number: M017
Pain Relief Gel-Roll OnMENTHOLTrifecta Pharmaceuticals USA51b403dc-fc9b-0cad-e063-6394a90af0812026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC5edddb99-6596-4a3b-b361-1cc04d032c312026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC684faf63-5e44-4471-8384-e8fa7c0d842a2026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC4c798b06-6ee5-41d1-8a14-f6889512ade32026-05-13WarningsExact identifier
application number: M017
BIOFREEZEMENTHOLReckitt Benckiser LLC83d5c2f2-2413-4d28-83b2-0808d0917b4d2026-05-13WarningsExact identifier
application number: M017
Scalpicin Anti-Itch Maximum StrengthHYDROCORTISONEReckitt Benckiser LLC7b1a29fa-b266-43e6-a87b-aa3c96ab40412026-05-13WarningsExact 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