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 10 of 69 · 1,369 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BEVERLY HILLS MD HYDRARESCUE TREATMENTDIMETHICONEBeverly Hills MD, LLC4ed33a43-d059-2589-e063-6294a90a30b32026-04-09WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMWAL-MART STORES INC00faa772-53f3-9276-e063-6394a90a2dab2026-04-07WarningsExact identifier
application number: M016
ProCure Zinc OxideZINC OXIDETwin Med LLC37a30ee5-fd33-b410-e063-6294a90aef722026-04-07WarningsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALCVS Pharmacy, Inc.4a43b1a2-2156-e490-e063-6294a90a6f842026-04-07Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE 8%, ZINC OXIDE 8%Farmacias De Similares TX LLC4ecd0add-11c9-cf3b-e063-6394a90adff62026-04-06WarningsExact identifier
application number: M016
PetroleumWHITE PETROLATUMCVS Pharmacy, Inc.4dc08832-e610-4e62-a6af-cadaa339e39e2026-04-06Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZEL SPRAYCVS Pharmacy53db78a8-eb2d-431b-84c1-73e99bb9d3d12026-04-06WarningsExact identifier
application number: M016
PetroleumWHITE PETROLATUMAmazon.com Services LLC616ef87d-1518-46aa-8e12-9a1b678d49802026-04-06Warnings, Adverse reactionsExact identifier
application number: M016
Stabilizing Repair SerumOATMEALDermalogica, LLC.86b7b230-5424-46d3-8058-656f5172fc702026-04-02WarningsExact identifier
application number: M016
calamineCALAMINE AND ZINC OXIDESTRATEGIC SOURCING SERVICES4e6a7bdf-4ef1-65e2-e063-6394a90ae1242026-04-01WarningsExact identifier
application number: M016
Aveeno Eczema Therapy Rescue Relief Treatment Gel CreamCOLLOIDAL OATMEALKenvue Brands LLC4e4e1797-26e6-a67b-e063-6294a90af4382026-03-31WarningsExact identifier
application number: M016
ChapStick Classic SpearmintSKIN PROTECTANT LIP BALMSuave Brands Co., LLC42769bb4-f6e4-bf47-e063-6294a90ad9742026-03-31WarningsExact identifier
application number: M016
Target Advanced Scar GelADVANCED SCAR GELTarget Corporation86c215fe-aad4-45d1-bdb7-cde00a115c5c2026-03-31WarningsExact identifier
application number: M016
Zinc oxide, DimethiconeZINC OXIDE, DIMETHICONEWalmart Inc.4cbf9492-33cd-e6d4-e063-6294a90ab0012026-03-31Warnings, Adverse reactionsExact identifier
application number: M016
Critic-Aid ClearPETROLATUMColoplast Corpa92c18f7-52b2-43e4-bae3-2bab9de226712026-03-31WarningsExact identifier
application number: M016
3M Cavilon Durable BarrierDIMETHICONESolventum US LLCf3f8be33-4ad2-4f5f-ac94-ddfbe0280b832026-03-31WarningsExact identifier
application number: M016
XIMONTH Foot SanitizerGLYCERINShantou Ximonth Biotechnology Co., Ltd.4e38d24d-3745-c121-e063-6394a90abbb52026-03-30WarningsExact identifier
application number: M016
DynashieldZINC OXIDEDynarex Corporation59fd865c-b81d-43ad-8fa0-c37ca05577692026-03-30WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin ProtectantCOLLOIDAL OATMEALPort Jervis Laboratories, Inc4e43b65c-d5bb-f228-e063-6294a90ad08d2026-03-30WarningsExact identifier
application number: M016
ChapStick Classic OriginalSKIN PROTECTANT LIP BALMSuave Brands Co., LLC4275956d-275a-4e31-e063-6394a90a78d32026-03-30WarningsExact 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