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 18 of 69 · 1,369 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Witch HazelWITCH HAZELUnited Natural Foods, Inc. dba UNFId2d1bd9e-7025-4151-95f2-a2f521dc2be82026-02-17Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMStrategic Sourcing Services LLC043375b2-e636-4822-9e05-df2327d299862026-02-17Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMStrategic Sourcing Services LLC3ade1f7f-a870-4f77-96b9-f63bf4cdf5ae2026-02-17Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMValu Merchandisers Company4113bb6e-070a-4116-a8d6-12c6b4475beb2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEValu Merchandisers Companye5465ddd-e38c-44a4-bb9b-3edbc636576d2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMValu Merchandisers Company8b8decec-e921-4ff9-bb49-7e38e34724f62026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONEValu Merchandisers Company0cccadd7-11f3-5d1f-e063-6294a90a55c42026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELValu Merchandisers Company7c6fa37f-79b8-4409-b7a9-3f02332f887a2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEUnited Natural Foods, Inc. dba UNFI014d0028-486e-4f1c-a14f-8162e393ebca2026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMUnited Natural Foods, Inc. dba UNFI29a3a719-5e8b-407d-b9d9-bdba267582922026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATEUnited Natural Foods, Inc. dba UNFI242adc68-f9e0-4f69-a580-a107d1634b502026-02-16Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDETopco Associates LLC8acb1b47-70ed-4aa2-a7c0-e807042affc72026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDTopco Associates LLC2b32e720-ac71-4d60-bc06-e28a00f8a4502026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMTopco Associates LLC3babe2cf-9e6c-4f22-940f-c1fdf489f1c72026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATETopco Associates LLC8d3d1ff5-4868-495d-807c-e45aa2176f632026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
HealingPETROLATUMTopco Associates LLCb929b159-4af5-4a03-8e7c-676a6ba2bf552026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLTopco Associates LLC15d1ae3f-509c-4e6b-8f0c-cf92656803582026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMTopco Associates LLCcd7f1727-0b6e-4993-9820-43783994efa12026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
DimethiconeDIMETHICONETopco Associates LLCf37f17f7-f084-4b74-8361-178d2315a4762026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Baby Eczema TherapyCOLLOIDAL OATMEALTopco Associates LLC4f6af42c-f41e-455f-b94b-3793bf0b9a3f2026-02-13Warnings, Adverse reactionsExact 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