Home NDC 10578-131 Dr. Blue
Product NDC 10578-131
11-digit product format 105780131
Labeler code 10578
Product ID 10578-131_3b057467-ca8c-48c2-99ad-80a012b5f74b
Type HUMAN OTC DRUG
Nonproprietary name menthol
Dosage form GEL
Route TOPICAL
Labeler Indiana Botanic Gardens
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2016-11-01
Substance MENTHOL
Active strength 4.58 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 Dr. Blue
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 4.58 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1549850 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 10578-131-02 Dr. Blue 57 g in 1 TUBE GEL 57 1 10578-131-05 Dr. Blue 142 g in 1 JAR GEL 142 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10578-131 DR. BLUE (MENTHOL) GEL [INDIANA BOTANIC GARDENS] 1 Current NDC, Legacy NDC, 2 package rows 20161111_1b1150bd-e087-4d8f-b0d6-0d935cf6e31e.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 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10578-131-02 10578013102 57 g in 1 TUBE (10578-131-02) 57 g 2016-11-01 0000-00-00 No No Current 10578-131-05 10578013105 142 g in 1 JAR (10578-131-05) 142 g 2016-11-01 0000-00-00 No No Current