eczema care moisturizing 3 oz.

Generic: colloidal oatmeal

Labeler: rejoice international inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH FINAL Inactive Finished

Drug Facts

Product Profile

Brand Name eczema care moisturizing 3 oz.
Generic Name colloidal oatmeal
Labeler rejoice international inc.
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

oatmeal 10 mg/mL

Manufacturer
Rejoice International Inc.

Identifiers & Regulatory

Product NDC 57337-101
Product ID 57337-101_83966e75-3cf0-410b-e053-2a91aa0a90f3
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH FINAL
Application Number part347
Listing Expiration 2026-12-31
Marketing Start 2019-03-08

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
increased histamine release [pe] cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57337101
Hyphenated Format 57337-101

Supplemental Identifiers

UPC
0849607065490
UNII
8PI54V663Y
NUI
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 eczema care moisturizing 3 oz. (source: ndc)
Generic Name colloidal oatmeal (source: ndc)
Application Number part347 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 85 mL in 1 TUBE (57337-101-01)
source: ndc

Packages (1)

57337-101-01 85 mL in 1 TUBE (57337-101-01)

Ingredients (1)

oatmeal (10 mg/mL)

Linked Drug Pages (1)

Eczema Care Moisturizing 3 oz. ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "83966e75-3cf0-410b-e053-2a91aa0a90f3", "openfda": {"nui": ["N0000185371", "N0000185375", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962", "N0000185016"], "upc": ["0849607065490"], "unii": ["8PI54V663Y"], "spl_set_id": ["83967d26-159a-e95c-e053-2991aa0af53a"], "pharm_class_cs": ["Allergens [CS]", "Dietary Proteins [CS]", "Plant Proteins [CS]"], "pharm_class_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": ["Rejoice International Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "85 mL in 1 TUBE (57337-101-01)", "package_ndc": "57337-101-01", "marketing_start_date": "20190308"}], "brand_name": "Eczema Care Moisturizing 3 oz.", "product_id": "57337-101_83966e75-3cf0-410b-e053-2a91aa0a90f3", "dosage_form": "LOTION", "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]"], "product_ndc": "57337-101", "generic_name": "Colloidal Oatmeal", "labeler_name": "Rejoice International Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Eczema Care Moisturizing", "brand_name_suffix": "3 oz.", "active_ingredients": [{"name": "OATMEAL", "strength": "10 mg/mL"}], "application_number": "part347", "marketing_category": "OTC MONOGRAPH FINAL", "marketing_start_date": "20190308", "listing_expiration_date": "20261231"}