FDA.reportPublic FDA data

Zpol ULTRA

Product NDC
55715-008
11-digit product format
557150008
Labeler code
55715
Product ID
55715-008_315525bd-c7a7-77aa-e063-6394a90a89bf
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, METHYL SALICYLATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Laboratorios Zepol S.A.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-01
Substance
MENTHOL; METHYL SALICYLATE
Active strength
2.84; 18.24 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
Zpol ULTRA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL2.84 g/100g
METHYL SALICYLATE18.24 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A, LAV5U5022Y
Rxcui2684042

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55715-008-01Zpol ULTRA29 g in 1 BOTTLE, PLASTICCREAM293
55715-008-02Zpol ULTRA59 g in 1 BOTTLE, PLASTICCREAM593
55715-008-03Zpol ULTRA119 g in 1 BOTTLE, PLASTICCREAM1193

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55715-008ZPOL ULTRA (MENTHOL, METHYL SALICYLATE) CREAM [LABORATORIOS ZEPOL S.A.]3Current NDC, 3 package rows20250403_1a1433a6-8d04-96df-e063-6394a90a987b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2684042menthol 2.84 % / methyl salicylate 18.24 % Topical CreamPSN1a1433a6-8d04-96df-e063-6394a90a987b3
2684042menthol 28.4 MG/ML / methyl salicylate 182 MG/ML Topical CreamSCD1a1433a6-8d04-96df-e063-6394a90a987b3
2684042menthol 2.84 % / methyl salicylate 18.24 % Topical CreamSY1a1433a6-8d04-96df-e063-6394a90a987b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55715-008-015571500080129 g in 1 BOTTLE, PLASTIC (55715-008-01) 29 g2025-04-01NoNoCurrent
55715-008-025571500080259 g in 1 BOTTLE, PLASTIC (55715-008-02) 59 g2025-04-01NoNoCurrent
55715-008-0355715000803119 g in 1 BOTTLE, PLASTIC (55715-008-03) 119 g2025-04-01NoNoCurrent