dermatitis face balm

Generic: colloidal oatmeal

Labeler: skinfix, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dermatitis face balm
Generic Name colloidal oatmeal
Labeler skinfix, inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

oatmeal 5 g/100g

Manufacturer
Skinfix, Inc.

Identifiers & Regulatory

Product NDC 61328-121
Product ID 61328-121_47ebdead-4009-888b-e063-6394a90a1362
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2027-12-31
Marketing Start 2022-02-03

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 61328121
Hyphenated Format 61328-121

Supplemental Identifiers

RxCUI
1738987
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 dermatitis face balm (source: ndc)
Generic Name colloidal oatmeal (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 5 g/100g
source: ndc
Packaging
  • 13.5 g in 1 TUBE (61328-121-12)
source: ndc

Packages (1)

61328-121-12 13.5 g in 1 TUBE (61328-121-12)

Ingredients (1)

oatmeal (5 g/100g)

Linked Drug Pages (1)

DERMATITIS FACE BALM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "47ebdead-4009-888b-e063-6394a90a1362", "openfda": {"nui": ["N0000185371", "N0000185375", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962", "N0000185016"], "unii": ["8PI54V663Y"], "rxcui": ["1738987"], "spl_set_id": ["86d2db7d-f1d4-4bca-aba4-d4c96b83c1a6"], "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": ["Skinfix, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "13.5 g in 1 TUBE (61328-121-12)", "package_ndc": "61328-121-12", "marketing_start_date": "20220203"}], "brand_name": "DERMATITIS FACE BALM", "product_id": "61328-121_47ebdead-4009-888b-e063-6394a90a1362", "dosage_form": "OINTMENT", "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": "61328-121", "generic_name": "Colloidal Oatmeal", "labeler_name": "Skinfix, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DERMATITIS FACE BALM", "active_ingredients": [{"name": "OATMEAL", "strength": "5 g/100g"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220203", "listing_expiration_date": "20271231"}