Home NDC 49967-586 La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant
Product NDC 49967-586
11-digit product format 499670586
Labeler code 49967
Product ID 49967-586_7c83dea0-3331-4ad0-9a9d-036e7fa22ab2
Type HUMAN OTC DRUG
Nonproprietary name Glycerin
Dosage form GEL
Route TOPICAL
Labeler L'Oreal USA Products Inc
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-01
Substance GLYCERIN
Active strength 10 mg/mL
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
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 La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLYCERIN 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PDC6A3C0OX Internal UNII 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 49967-586-01 La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant 40 mL in 1 TUBE GEL 40 3 49967-586-01 La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant 1 in 1 CARTON GEL 1 3 49967-586-02 La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant 3 mL in 1 TUBE GEL 3 3 49967-586-02 La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant 1 in 1 CARTON GEL 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49967-586 LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE CICAPLAST DEFENSE B5 SKIN PROTECTANT (GLYCERIN) GEL [L'OREAL USA PRODUCTS INC] 3 Current NDC, 4 package rows 20231212_32eaaaab-41bd-4efe-a71d-92e3a702c1e5.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 39 of 68 · 1,357 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 49967-586-01 49967058601 1 TUBE in 1 CARTON (49967-586-01) / 40 mL in 1 TUBE 1 tube 2023-01-01 No No Current 49967-586-02 49967058602 1 TUBE in 1 CARTON (49967-586-02) / 3 mL in 1 TUBE 1 tube 2023-01-01 No No Current