Medline

Product NDC
53329-972
11-digit product format
533290972
Labeler code
53329
Product ID
53329-972_387c2d55-f00b-422f-e063-6294a90a898e
Type
HUMAN OTC DRUG
Nonproprietary name
menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Medline Industries, LP
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-01
Substance
MENTHOL
Active strength
5 mg/100mg
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Medline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL5 mg/100mg

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
420222Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0d947aa6-045e-d001-e063-6294a90a3657Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-972-05Medline5 in 1 BOXPATCH52
53329-972-05Medline1 in 1 POUCHPATCH12

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MedlineMENTHOLMedline Industries, LP0d947aa6-045e-d001-e063-6294a90a36572025-06-26WarningsExact identifier
ndc (product): 53329-972

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
420222menthol 5 % Medicated PatchPSN0d947aa6-045e-d001-e063-6294a90a36572
420222menthol 0.05 MG/MG Medicated PatchSCD0d947aa6-045e-d001-e063-6294a90a36572
420222menthol 5 % Medicated PatchSY0d947aa6-045e-d001-e063-6294a90a36572

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53329-972-05533290972055 POUCH in 1 BOX (53329-972-05) / 1 PATCH in 1 POUCH / 500 mg in 1 PATCH5 pouch2025-02-01NoNoCurrent