pediadermics eczema 3

Generic: colloidal oatmeal, dimethicone

Labeler: renu laboratories, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name pediadermics eczema 3
Generic Name colloidal oatmeal, dimethicone
Labeler renu laboratories, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

dimethicone 3.36 g/168g, oatmeal .168 g/168g

Manufacturer
Renu Laboratories, LLC

Identifiers & Regulatory

Product NDC 76348-580
Product ID 76348-580_44fe1bad-8844-9960-e063-6394a90a8a7a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2020-10-01

Pharmacologic Class

Established (EPC)
non-standardized food allergenic extract [epc] non-standardized plant allergenic extract [epc]
Chemical Structure
allergens [cs] dietary proteins [cs] plant proteins [cs]
Physiologic Effect
skin barrier activity [pe] increased histamine release [pe] cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76348580
Hyphenated Format 76348-580

Supplemental Identifiers

UNII
92RU3N3Y1O 8PI54V663Y
NUI
N0000010282 N0000185371 N0000185375 N0000175629 N0000184306 M0000728 M0006342 M0016962 N0000185016

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 pediadermics eczema 3 (source: ndc)
Generic Name colloidal oatmeal, dimethicone (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 3.36 g/168g
  • .168 g/168g
source: ndc
Packaging
  • 168 g in 1 TUBE (76348-580-06)
source: ndc

Packages (1)

76348-580-06 168 g in 1 TUBE (76348-580-06)

Ingredients (2)

dimethicone (3.36 g/168g) oatmeal (.168 g/168g)

Linked Drug Pages (1)

Pediadermics eczema 3 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "44fe1bad-8844-9960-e063-6394a90a8a7a", "openfda": {"nui": ["N0000010282", "N0000185371", "N0000185375", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962", "N0000185016"], "unii": ["92RU3N3Y1O", "8PI54V663Y"], "spl_set_id": ["af861f0b-4387-6861-e053-2995a90a8bfa"], "pharm_class_cs": ["Allergens [CS]", "Dietary Proteins [CS]", "Plant Proteins [CS]"], "pharm_class_pe": ["Skin Barrier Activity [PE]", "Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Non-Standardized Food Allergenic Extract [EPC]", "Non-Standardized Plant Allergenic Extract [EPC]"], "manufacturer_name": ["Renu Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "168 g in 1 TUBE (76348-580-06)", "package_ndc": "76348-580-06", "marketing_start_date": "20201001"}], "brand_name": "Pediadermics eczema 3", "product_id": "76348-580_44fe1bad-8844-9960-e063-6394a90a8a7a", "dosage_form": "CREAM", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Dietary Proteins [CS]", "Grain Proteins [EXT]", "Increased Histamine Release [PE]", "Non-Standardized Food Allergenic Extract [EPC]", "Non-Standardized Plant Allergenic Extract [EPC]", "Plant Proteins [CS]", "Skin Barrier Activity [PE]"], "product_ndc": "76348-580", "generic_name": "Colloidal Oatmeal, Dimethicone", "labeler_name": "Renu Laboratories, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pediadermics eczema 3", "active_ingredients": [{"name": "DIMETHICONE", "strength": "3.36 g/168g"}, {"name": "OATMEAL", "strength": ".168 g/168g"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20201001", "listing_expiration_date": "20261231"}