Home NDC 55715-008 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 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 Zpol ULTRA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 2.84 g/100g METHYL SALICYLATE 18.24 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup LAV5U5022Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2684042 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55715-008-01 Zpol ULTRA 29 g in 1 BOTTLE, PLASTIC CREAM 29 3 55715-008-02 Zpol ULTRA 59 g in 1 BOTTLE, PLASTIC CREAM 59 3 55715-008-03 Zpol ULTRA 119 g in 1 BOTTLE, PLASTIC CREAM 119 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55715-008 ZPOL ULTRA (MENTHOL, METHYL SALICYLATE) CREAM [LABORATORIOS ZEPOL S.A.] 3 Current NDC, 3 package rows 20250403_1a1433a6-8d04-96df-e063-6394a90a987b.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55715-008-01 55715000801 29 g in 1 BOTTLE, PLASTIC (55715-008-01) 29 g 2025-04-01 No No Current 55715-008-02 55715000802 59 g in 1 BOTTLE, PLASTIC (55715-008-02) 59 g 2025-04-01 No No Current 55715-008-03 55715000803 119 g in 1 BOTTLE, PLASTIC (55715-008-03) 119 g 2025-04-01 No No Current