FDA.reportPublic FDA data

Satya ORGANIC FRAGRANCE-FREE ECZEMA RELIEF

Product NDC
82590-030
Requested package NDC
82590-030-03
11-digit product format
825900030
Labeler code
82590
Product ID
82590-030_4d20c6f9-de5f-48bd-8ab1-b82bccb157fb
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Satya Organic Inc.
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-08-17
Marketing end
0000-00-00
Substance
OATMEAL
Active strength
10 mg/mL
Pharmacologic classes
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]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage82590-03082590-030-03DDiscontinued by firm2026-10-15

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82590-030-012025-01-30C16284748780-12cef2736-6d93-d83d-e063-dadaa90ab31fSatya ORGANIC FRAGRANCE-FREE ECZEMA RELIEF
82590-030-022025-01-30C16284748780-12cef2736-61dc-d83d-e063-dadaa90ab31fSatya ORGANIC FRAGRANCE-FREE ECZEMA RELIEF
82590-030-032024-02-01C16284748780-11030e365-0375-111a-e063-dadaa90a10e2Satya ORGANIC FRAGRANCE-FREE ECZEMA RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82590-030-02Satya ORGANIC FRAGRANCE-FREE ECZEMA RELIEF10 mL in 1 BOXOINTMENT107
82590-030-03Satya ORGANIC FRAGRANCE-FREE ECZEMA RELIEF60 mL in 1 POUCHOINTMENT606
82590-030-01Satya ORGANIC FRAGRANCE-FREE ECZEMA RELIEF30 mL in 1 TUBEOINTMENT302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82590-030SATYA ORGANIC FRAGRANCE-FREE ECZEMA RELIEF (COLLOIDAL OATMEAL) OINTMENT [SATYA ORGANIC INC.]7Legacy NDC, 1 package rows20231005_df37848d-afca-45b0-80b3-d24353123d18.zip
82590-030SATYA ORGANIC FRAGRANCE-FREE ECZEMA RELIEF (COLLOIDAL OATMEAL) OINTMENT [SATYA ORGANIC INC.]6Legacy NDC, 1 package rows20240202_75c22084-7c77-41f2-b540-f9ef51aee9b1.zip
82590-030SATYA ORGANIC FRAGRANCE-FREE ECZEMA RELIEF (COLLOIDAL OATMEAL) OINTMENT [SATYA ORGANIC INC.]2Legacy NDC, 1 package rows20230121_9b724430-20d1-4081-b7f5-f5732595dd02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1545142colloidal oatmeal 1 % Topical OintmentPSNdf37848d-afca-45b0-80b3-d24353123d187
1545142colloidal oatmeal 0.01 MG/MG Topical OintmentSCDdf37848d-afca-45b0-80b3-d24353123d187
1545142colloidal oatmeal 1 % Topical OintmentSYdf37848d-afca-45b0-80b3-d24353123d187
1545142colloidal oatmeal 1 % Topical OintmentPSN75c22084-7c77-41f2-b540-f9ef51aee9b16
1545142colloidal oatmeal 0.01 MG/MG Topical OintmentSCD75c22084-7c77-41f2-b540-f9ef51aee9b16
1545142colloidal oatmeal 1 % Topical OintmentSY75c22084-7c77-41f2-b540-f9ef51aee9b16
1545142colloidal oatmeal 1 % Topical OintmentPSN9b724430-20d1-4081-b7f5-f5732595dd022
1545142colloidal oatmeal 0.01 MG/MG Topical OintmentSCD9b724430-20d1-4081-b7f5-f5732595dd022
1545142colloidal oatmeal 1 % Topical OintmentSY9b724430-20d1-4081-b7f5-f5732595dd022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82590-030-038259000300360 mL in 1 POUCH (82590-030-03) 60 ml2022-12-140000-00-00NoNoCurrent