Home NDC 55758-417 Milagroso
Product NDC 55758-417
11-digit product format 557580417
Labeler code 55758
Product ID 55758-417_4df21676-902c-2e91-e063-6394a90afffb
Type HUMAN OTC DRUG
Nonproprietary name Camphor
Dosage form OINTMENT
Route TOPICAL
Labeler Pharmadel LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-01
Substance CAMPHOR (SYNTHETIC)
Active strength 10 g/100g
NDC exclude flag No
Listing certified through 2027-12-31
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 Milagroso
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAMPHOR (SYNTHETIC) 10 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5TJD82A1ET Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 418604 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55758-417-02 Milagroso 57 g in 1 JAR OINTMENT 57 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55758-417 MILAGROSO (CAMPHOR) OINTMENT [PHARMADEL LLC] 2 Current NDC, 1 package rows 20240402_12b0401c-84d5-07cd-e063-6394a90a052c.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 55758-417-02 55758041702 57 g in 1 JAR (55758-417-02) 57 g 2024-04-01 No No Current