cetaphil cracked skin repair balm

Generic: dimethicone

Labeler: galderma laboratories, l.p.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cetaphil cracked skin repair balm
Generic Name dimethicone
Labeler galderma laboratories, l.p.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

dimethicone 10 mg/g

Manufacturer
Galderma Laboratories, L.P.

Identifiers & Regulatory

Product NDC 0299-4115
Product ID 0299-4115_40277fde-372e-4ded-b7f8-15168d11582a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2021-05-01

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02994115
Hyphenated Format 0299-4115

Supplemental Identifiers

RxCUI
200010
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 cetaphil cracked skin repair balm (source: ndc)
Generic Name dimethicone (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0299-4115-00) / 85 g in 1 TUBE
source: ndc

Packages (1)

0299-4115-00 1 TUBE in 1 CARTON (0299-4115-00) / 85 g in 1 TUBE

Ingredients (1)

dimethicone (10 mg/g)

Linked Drug Pages (1)

Cetaphil Cracked Skin Repair Balm ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "40277fde-372e-4ded-b7f8-15168d11582a", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O"], "rxcui": ["200010"], "spl_set_id": ["5efb3ef0-6ee9-4ef8-b81e-90bd1825c956"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Galderma Laboratories, L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0299-4115-00)  / 85 g in 1 TUBE", "package_ndc": "0299-4115-00", "marketing_start_date": "20210501"}], "brand_name": "Cetaphil Cracked Skin Repair Balm", "product_id": "0299-4115_40277fde-372e-4ded-b7f8-15168d11582a", "dosage_form": "CREAM", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "0299-4115", "generic_name": "Dimethicone", "labeler_name": "Galderma Laboratories, L.P.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetaphil Cracked Skin Repair Balm", "active_ingredients": [{"name": "DIMETHICONE", "strength": "10 mg/g"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210501", "listing_expiration_date": "20261231"}