Home NDC 49967-494 Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALM
Product NDC 49967-494
11-digit product format 499670494
Labeler code 49967
Product ID 49967-494_611ae21f-a874-492d-9ffe-4be59e8629b5
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form LIPSTICK
Route TOPICAL
Labeler L'Oreal USA Products Inc
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-06-01
Substance MENTHOL
Active strength 5 mg/g
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 Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 5 mg/g
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 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 49967-494-01 Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALM 4.4 g in 1 TUBE LIPSTICK 4.4 1 49967-494-01 Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALM 1 in 1 BLISTER PACK LIPSTICK 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49967-494 MAYBELLINE NEW YORK BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALM (MENTHOL) LIPSTICK [L'OREAL USA PRODUCTS INC] 1 Current NDC, 2 package rows 20240704_d580982f-dda6-4b03-bf84-342b9f2c6d93.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 49967-494-01 49967049401 1 TUBE in 1 BLISTER PACK (49967-494-01) / 4.4 g in 1 TUBE 1 tube 2016-06-01 No No Current