la roche posay laboratoire dermatologique cicaplast defense b5 skin protectant

Generic: glycerin

Labeler: l'oreal usa products inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name la roche posay laboratoire dermatologique cicaplast defense b5 skin protectant
Generic Name glycerin
Labeler l'oreal usa products inc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

glycerin 10 mg/mL

Manufacturer
L'Oreal USA Products Inc

Identifiers & Regulatory

Product NDC 49967-586
Product ID 49967-586_7c83dea0-3331-4ad0-9a9d-036e7fa22ab2
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2023-01-01

Pharmacologic Class

Established (EPC)
non-standardized chemical allergen [epc]
Chemical Structure
allergens [cs] glycerol [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe] increased igg production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49967586
Hyphenated Format 49967-586

Supplemental Identifiers

UNII
PDC6A3C0OX
NUI
N0000185370 N0000175629 N0000184306 N0000185001 M0000728 M0009417

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name la roche posay laboratoire dermatologique cicaplast defense b5 skin protectant (source: ndc)
Generic Name glycerin (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (49967-586-01) / 40 mL in 1 TUBE
  • 1 TUBE in 1 CARTON (49967-586-02) / 3 mL in 1 TUBE
source: ndc

Packages (2)

49967-586-01 1 TUBE in 1 CARTON (49967-586-01) / 40 mL in 1 TUBE 49967-586-02 1 TUBE in 1 CARTON (49967-586-02) / 3 mL in 1 TUBE

Ingredients (1)

glycerin (10 mg/mL)

Linked Drug Pages (1)

La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "7c83dea0-3331-4ad0-9a9d-036e7fa22ab2", "openfda": {"nui": ["N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417"], "unii": ["PDC6A3C0OX"], "spl_set_id": ["32eaaaab-41bd-4efe-a71d-92e3a702c1e5"], "pharm_class_cs": ["Allergens [CS]", "Glycerol [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]"], "pharm_class_epc": ["Non-Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["L'Oreal USA Products Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (49967-586-01)  / 40 mL in 1 TUBE", "package_ndc": "49967-586-01", "marketing_start_date": "20230101"}, {"sample": false, "description": "1 TUBE in 1 CARTON (49967-586-02)  / 3 mL in 1 TUBE", "package_ndc": "49967-586-02", "marketing_start_date": "20230101"}], "brand_name": "La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant", "product_id": "49967-586_7c83dea0-3331-4ad0-9a9d-036e7fa22ab2", "dosage_form": "GEL", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Glycerol [CS]", "Increased Histamine Release [PE]", "Increased IgG Production [PE]", "Non-Standardized Chemical Allergen [EPC]"], "product_ndc": "49967-586", "generic_name": "Glycerin", "labeler_name": "L'Oreal USA Products Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant", "active_ingredients": [{"name": "GLYCERIN", "strength": "10 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230101", "listing_expiration_date": "20261231"}