colloidal oatmeal

Generic: colloidal oatmeal

Labeler: h e b
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name colloidal oatmeal
Generic Name colloidal oatmeal
Labeler h e b
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

oatmeal 10 mg/g

Manufacturer
H E B

Identifiers & Regulatory

Product NDC 37808-128
Product ID 37808-128_4b93fc15-eb48-5e70-e063-6394a90a09bc
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2027-12-31
Marketing Start 2019-04-11

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 37808128
Hyphenated Format 37808-128

Supplemental Identifiers

RxCUI
240651
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 colloidal oatmeal (source: ndc)
Generic Name colloidal oatmeal (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 141 g in 1 TUBE (37808-128-28)
source: ndc

Packages (1)

37808-128-28 141 g in 1 TUBE (37808-128-28)

Ingredients (1)

oatmeal (10 mg/g)

Linked Drug Pages (1)

Colloidal oatmeal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4b93fc15-eb48-5e70-e063-6394a90a09bc", "openfda": {"nui": ["N0000185371", "N0000185375", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962", "N0000185016"], "unii": ["8PI54V663Y"], "rxcui": ["240651"], "spl_set_id": ["ce9ffcc1-a4c3-4771-ae27-ba99c74bb1ba"], "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": ["H E B"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "141 g in 1 TUBE (37808-128-28)", "package_ndc": "37808-128-28", "marketing_start_date": "20190411"}], "brand_name": "Colloidal oatmeal", "product_id": "37808-128_4b93fc15-eb48-5e70-e063-6394a90a09bc", "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]"], "product_ndc": "37808-128", "generic_name": "Colloidal oatmeal", "labeler_name": "H E B", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Colloidal oatmeal", "active_ingredients": [{"name": "OATMEAL", "strength": "10 mg/g"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190411", "listing_expiration_date": "20271231"}