Home NDC 69625-587-01 La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5
Product NDC 69625-587
Requested package NDC 69625-587-01
11-digit product format 696250587
Labeler code 69625
Product ID 69625-587_ffa0730d-097a-45f4-96a5-f56763bb26bd
Type HUMAN OTC DRUG
Nonproprietary name Glycerin
Dosage form GEL
Route TOPICAL
Labeler Cosmetique Active Production
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
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 69625-587-01 La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 40 mL in 1 TUBE GEL 40 2 69625-587-01 La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 1 in 1 CARTON GEL 1 2 69625-587-02 La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 3 mL in 1 TUBE GEL 3 2 69625-587-02 La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 1 in 1 CARTON GEL 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69625-587 LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE CICAPLAST DEFENSE B5 (GLYCERIN) GEL [COSMETIQUE ACTIVE PRODUCTION] 2 Current NDC, 4 package rows 20231212_01c8a0d5-bcd1-4639-be45-530a226401f0.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 51 of 68 · 1,350 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69625-587-01 69625058701 1 TUBE in 1 CARTON (69625-587-01) / 40 mL in 1 TUBE 1 tube 2023-01-01 No No Current