FDA.reportPublic FDA data

Eczema Relief

Product NDC
55910-653
11-digit product format
559100653
Labeler code
55910
Product ID
55910-653_4c0f4eee-c522-76ed-e063-6294a90a1dca
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Old East Main Co.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-12-07
Substance
OATMEAL
Active strength
10 mg/11g
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Eczema Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL10 mg/11g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8PI54V663YInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b2dba027-c295-4a41-8d30-144904e1aa34Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-653-34Eczema Relief226 g in 1 TUBEOINTMENT2269

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-653ECZEMA RELIEF (COLLOIDAL OATMEAL) OINTMENT [OLD EAST MAIN CO]7Current NDC, Legacy NDC, 1 package rows20240925_b2dba027-c295-4a41-8d30-144904e1aa34.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 20 of 69 · 1,369 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PetroleumWHITE PETROLATUMSalado Sales Inc.f973e3a5-3b45-4842-99ce-dff676ae1f962026-02-06Warnings, Adverse reactionsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMPharmacy Value Alliance, LLC0ce03cd1-c48d-45cf-b11f-08bade55dcb62026-02-05Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONEPublix Super Markets, Inc.28ac9de4-2a63-4839-bed5-9bcc59ebeb2a2026-02-05Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELPublix Super Markets, Inc.0098c983-c518-4a14-8635-c7bdde7bff4f2026-02-05Warnings, Adverse reactionsExact identifier
application number: M016
TN Dickinsons Pain and Itch ReliefPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEDickinson Brands Inc.537c9c27-ee81-4920-8e3f-21edb844c9cf2026-02-05WarningsExact identifier
application number: M016
Aveeno Eczema Therapy Nighttime Itch Relief BalmCOLLOIDAL OATMEALKenvue Brands LLCe3350a8f-b983-7c4d-e053-2a95a90a53f52026-02-04WarningsExact identifier
application number: M016
TENA Proskin protective creamZINC OXIDEEssity Professional Hygiene North America LLCb840377f-a297-4aff-900e-7ea8b7c987172026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMHarris Teeterde380df6-cc6e-4b2a-98de-fc08eeb6e8ea2026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMHy-Vee, Inc.45867f42-9562-c111-e063-6394a90adb702026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONELidl US, LLCc82f236d-c27f-458c-bcd8-19877d09e9a32026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONELidl US, LLC5e83811f-773f-43e7-bab8-f9e558fb0e002026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDMajor Pharmaceuticalsc25be68d-834a-4959-8d47-01ec789406ba2026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMMajor Pharmaceuticals0e7e11c5-a1f8-43c4-b8a6-2114910524042026-02-04Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)d76e116f-4b22-4633-8487-17ad3b5778c72026-02-04WarningsExact identifier
application number: M016
Comforts Petroleum JellyWHITE PETROLATUMKROGER3feb3638-1cdc-62d4-e063-6294a90a1d892026-02-03WarningsExact identifier
application number: M016
Daily MoisturizingDIMETHICONECVS Pharmacy, Inc.edc20df4-561e-486f-b9f1-900672a0f2a42026-02-03Warnings, Adverse reactionsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALCVS Pharmacy, Inc.a153842c-d9ce-4658-912b-362a6f20b0aa2026-02-03Warnings, Adverse reactionsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMDemoulas Super Markets, Inc702215f0-4cfd-4a23-b47a-da691c1366342026-02-03Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMDemoulas Super Markets, Inca3400c92-d37d-4f80-87b2-2a8e1a4468e42026-02-03Warnings, Adverse reactionsExact identifier
application number: M016
NeurexaCOLLOIDAL OATMEALMETHODIQ INC.494d7915-acad-260e-e063-6394a90a182c2026-02-03WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-653-3455910065334226 g in 1 TUBE (55910-653-34) 226 g2021-12-070000-00-00NoNoCurrent