comfort shield barrier

Generic: dimethicone

Labeler: sage products llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name comfort shield barrier
Generic Name dimethicone
Labeler sage products llc
Dosage Form CLOTH
Routes
TOPICAL
Active Ingredients

dimethicone 30 mg/g

Manufacturer
Sage Products LLC

Identifiers & Regulatory

Product NDC 53462-915
Product ID 53462-915_419e18cd-fa52-b78d-e063-6294a90a467c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 1990-01-01

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53462915
Hyphenated Format 53462-915

Supplemental Identifiers

RxCUI
968663 1088604
UNII
92RU3N3Y1O
NUI
N0000010282

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 comfort shield barrier (source: ndc)
Generic Name dimethicone (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/g
source: ndc
Packaging
  • 24 APPLICATOR in 1 PACKAGE (53462-915-24) / 24 g in 1 APPLICATOR
  • 3 APPLICATOR in 1 PACKAGE (53462-915-50) / 26 g in 1 APPLICATOR
  • 3 APPLICATOR in 1 PACKAGE (53462-915-51) / 19 g in 1 APPLICATOR
  • 8 APPLICATOR in 1 PACKAGE (53462-915-80) / 27 g in 1 APPLICATOR
source: ndc

Packages (4)

53462-915-24 24 APPLICATOR in 1 PACKAGE (53462-915-24) / 24 g in 1 APPLICATOR 53462-915-50 3 APPLICATOR in 1 PACKAGE (53462-915-50) / 26 g in 1 APPLICATOR 53462-915-51 3 APPLICATOR in 1 PACKAGE (53462-915-51) / 19 g in 1 APPLICATOR 53462-915-80 8 APPLICATOR in 1 PACKAGE (53462-915-80) / 27 g in 1 APPLICATOR

Ingredients (1)

dimethicone (30 mg/g)

Linked Drug Pages (1)

Comfort Shield Barrier ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "419e18cd-fa52-b78d-e063-6294a90a467c", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O"], "rxcui": ["968663", "1088604"], "spl_set_id": ["cc08f571-84ae-4c2f-b09d-a83a8efc39f5"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Sage Products LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 APPLICATOR in 1 PACKAGE (53462-915-24)  / 24 g in 1 APPLICATOR", "package_ndc": "53462-915-24", "marketing_start_date": "20231211"}, {"sample": false, "description": "3 APPLICATOR in 1 PACKAGE (53462-915-50)  / 26 g in 1 APPLICATOR", "package_ndc": "53462-915-50", "marketing_start_date": "19900101"}, {"sample": false, "description": "3 APPLICATOR in 1 PACKAGE (53462-915-51)  / 19 g in 1 APPLICATOR", "package_ndc": "53462-915-51", "marketing_start_date": "19900101"}, {"sample": false, "description": "8 APPLICATOR in 1 PACKAGE (53462-915-80)  / 27 g in 1 APPLICATOR", "package_ndc": "53462-915-80", "marketing_start_date": "19900101"}], "brand_name": "Comfort Shield Barrier", "product_id": "53462-915_419e18cd-fa52-b78d-e063-6294a90a467c", "dosage_form": "CLOTH", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "53462-915", "generic_name": "dimethicone", "labeler_name": "Sage Products LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Comfort Shield Barrier", "active_ingredients": [{"name": "DIMETHICONE", "strength": "30 mg/g"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19900101", "listing_expiration_date": "20261231"}