superbalm

Generic: colloidal oatmeal 1%

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

Drug Facts

Product Profile

Brand Name superbalm
Generic Name colloidal oatmeal 1%
Labeler era organics, inc.
Dosage Form SALVE
Routes
TOPICAL
Active Ingredients

oatmeal .57 g/.57g

Manufacturer
Era Organics, Inc.

Identifiers & Regulatory

Product NDC 72400-300
Product ID 72400-300_44994dfb-94c0-115b-e063-6294a90adff4
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M006
Listing Expiration 2026-12-31
Marketing Start 2024-09-19

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 72400300
Hyphenated Format 72400-300

Supplemental Identifiers

UPC
0712411779160
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 superbalm (source: ndc)
Generic Name colloidal oatmeal 1% (source: ndc)
Application Number M006 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .57 g/.57g
source: ndc
Packaging
  • 57 g in 1 JAR (72400-300-02)
  • 113 g in 1 JAR (72400-300-04)
  • 227 g in 1 JAR (72400-300-08)
source: ndc

Packages (3)

72400-300-02 57 g in 1 JAR (72400-300-02) 72400-300-04 113 g in 1 JAR (72400-300-04) 72400-300-08 227 g in 1 JAR (72400-300-08)

Ingredients (1)

oatmeal (.57 g/.57g)

Linked Drug Pages (1)

Superbalm ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "44994dfb-94c0-115b-e063-6294a90adff4", "openfda": {"nui": ["N0000185371", "N0000185375", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962", "N0000185016"], "upc": ["0712411779160"], "unii": ["8PI54V663Y"], "spl_set_id": ["f5298e5e-583d-d74c-e053-2995a90affb5"], "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": ["Era Organics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "57 g in 1 JAR (72400-300-02)", "package_ndc": "72400-300-02", "marketing_start_date": "20240919"}, {"sample": false, "description": "113 g in 1 JAR (72400-300-04)", "package_ndc": "72400-300-04", "marketing_start_date": "20240919"}, {"sample": false, "description": "227 g in 1 JAR (72400-300-08)", "package_ndc": "72400-300-08", "marketing_start_date": "20251001"}], "brand_name": "Superbalm", "product_id": "72400-300_44994dfb-94c0-115b-e063-6294a90adff4", "dosage_form": "SALVE", "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": "72400-300", "generic_name": "Colloidal Oatmeal 1%", "labeler_name": "Era Organics, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Superbalm", "active_ingredients": [{"name": "OATMEAL", "strength": ".57 g/.57g"}], "application_number": "M006", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240919", "listing_expiration_date": "20261231"}