Home NDC 10157-1194 Lip Medex Lip Balm
Product NDC 10157-1194
11-digit product format 101571194
Labeler code 10157
Product ID 10157-1194_310b31e0-2782-4a70-a62e-1f2e06b3e36a
Type HUMAN OTC DRUG
Nonproprietary name PETROLATUM, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, and PHENOL
Dosage form STICK
Route TOPICAL
Labeler Blistex Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-01
Substance PETROLATUM; CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; PHENOL
Active strength 42; 1; 1; .6 g/100g; g/100g; 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 Lip Medex Lip Balm
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PETROLATUM 42 g/100g CAMPHOR (SYNTHETIC) 1 g/100g MENTHOL, UNSPECIFIED FORM 1 g/100g PHENOL .6 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
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 10157-1194-1 Lip Medex Lip Balm 4.25 g in 1 CYLINDER STICK 4.25 1 10157-1194-3 Lip Medex Lip Balm 4.25 g in 1 CYLINDER STICK 4.25 1 10157-1194-3 Lip Medex Lip Balm 3 in 1 CARTON STICK 3 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10157-1194 LIP MEDEX LIP BALM (PETROLATUM, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOL) STICK [BLISTEX INC.] 1 Current NDC, 3 package rows 20240703_988f97e8-a59f-4bc0-9d71-60607364a686.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 152 · 3,029 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 10157-1194-1 10157119401 4.25 g in 1 CYLINDER (10157-1194-1) 4.25 g 2024-07-01 No No Current 10157-1194-3 10157119403 3 CYLINDER in 1 CARTON (10157-1194-3) / 4.25 g in 1 CYLINDER 3 cylinder 2024-07-01 No No Current