all purpose healing baby cream

Generic: colloidal oatmeal

Labeler: spa de soleil
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name all purpose healing baby cream
Generic Name colloidal oatmeal
Labeler spa de soleil
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

oatmeal 1.18 mg/118mL

Manufacturer
Spa de Soleil

Identifiers & Regulatory

Product NDC 68062-3301
Product ID 68062-3301_48dea3cf-a1ab-1490-e063-6294a90aea66
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2027-12-31
Marketing Start 2025-06-13

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 680623301
Hyphenated Format 68062-3301

Supplemental Identifiers

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 all purpose healing baby cream (source: ndc)
Generic Name colloidal oatmeal (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1.18 mg/118mL
source: ndc
Packaging
  • 118 mL in 1 CANISTER (68062-3301-1)
source: ndc

Packages (1)

68062-3301-1 118 mL in 1 CANISTER (68062-3301-1)

Ingredients (1)

oatmeal (1.18 mg/118mL)

Linked Drug Pages (1)

All Purpose Healing Baby Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "48dea3cf-a1ab-1490-e063-6294a90aea66", "openfda": {"nui": ["N0000185371", "N0000185375", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962", "N0000185016"], "unii": ["8PI54V663Y"], "spl_set_id": ["377c2023-4cbb-cc01-e063-6294a90a7c68"], "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": ["Spa de Soleil"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 CANISTER (68062-3301-1)", "package_ndc": "68062-3301-1", "marketing_start_date": "20250713"}], "brand_name": "All Purpose Healing Baby Cream", "product_id": "68062-3301_48dea3cf-a1ab-1490-e063-6294a90aea66", "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": "68062-3301", "generic_name": "colloidal oatmeal", "labeler_name": "Spa de Soleil", "product_type": "HUMAN OTC DRUG", "brand_name_base": "All Purpose Healing Baby Cream", "active_ingredients": [{"name": "OATMEAL", "strength": "1.18 mg/118mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250613", "listing_expiration_date": "20271231"}