sarna

Generic: colloidal oatmeal

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

Drug Facts

Product Profile

Brand Name sarna
Generic Name colloidal oatmeal
Labeler crown laboratories, inc.
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

oatmeal 20 mg/mL

Manufacturer
Crown Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0316-0256
Product ID 0316-0256_483418a9-057e-f63f-e063-6294a90a4f38
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2027-12-31
Marketing Start 2025-01-12

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 03160256
Hyphenated Format 0316-0256

Supplemental Identifiers

RxCUI
1591951
UPC
0303160256752
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 sarna (source: ndc)
Generic Name colloidal oatmeal (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 5 mL in 1 TUBE (0316-0256-17)
  • 222 mL in 1 TUBE (0316-0256-75)
source: ndc

Packages (2)

0316-0256-17 5 mL in 1 TUBE (0316-0256-17) 0316-0256-75 222 mL in 1 TUBE (0316-0256-75)

Ingredients (1)

oatmeal (20 mg/mL)

Linked Drug Pages (1)

Sarna ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "483418a9-057e-f63f-e063-6294a90a4f38", "openfda": {"nui": ["N0000185371", "N0000185375", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962", "N0000185016"], "upc": ["0303160256752"], "unii": ["8PI54V663Y"], "rxcui": ["1591951"], "spl_set_id": ["2d6b1872-9f4d-9eb3-e063-6394a90ab675"], "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": ["Crown Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "5 mL in 1 TUBE (0316-0256-17)", "package_ndc": "0316-0256-17", "marketing_start_date": "20251111"}, {"sample": false, "description": "222 mL in 1 TUBE (0316-0256-75)", "package_ndc": "0316-0256-75", "marketing_start_date": "20250112"}], "brand_name": "Sarna", "product_id": "0316-0256_483418a9-057e-f63f-e063-6294a90a4f38", "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": "0316-0256", "generic_name": "Colloidal Oatmeal", "labeler_name": "Crown Laboratories, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sarna", "active_ingredients": [{"name": "OATMEAL", "strength": "20 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250112", "listing_expiration_date": "20271231"}