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 28 of 69 · 1,369 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Soteri Skin Baby Eczema Relief CreamCOLLOIDAL OATMEALSoteri Skin, Inc41d88ff2-22aa-8447-e063-6294a90aea0e2025-12-10WarningsExact identifier
application number: M016
Soteri Skin Active Flare-Up Eczema Relief CreamCOLLOIDAL OATMEALSoteri Skin, Inc.41b558d9-55ba-97ff-e063-6394a90a963b2025-12-10WarningsExact identifier
application number: M016
CeraVe Developed With Dermatologist Baby Eczema Relief CreamOATMEALL'Oreal USA Products Inc5d392529-9f0c-40bc-92ca-7003f8e64b1c2025-12-09WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Eczema Relief MoisturizingCOLLOIDAL OATMEALL'Oreal USA Products Incc4dde987-fe4e-4f8e-8f3a-1bc12c9588ed2025-12-09WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin ProtectantCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company446ddb19-4bdb-6827-e063-6394a90a6af82025-12-09WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Warm VanillaCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company45864832-51bb-4e24-e063-6294a90ab5542025-12-09WarningsExact identifier
application number: M016
AquaSootheAQUASOOTHEDynarex Corporation45878c3c-d05d-984c-e063-6294a90a46612025-12-09WarningsExact identifier
application number: M016
Soteri Skin Long-Term Eczema Relief CreamCOLLOIDAL OATMEALSoteri Skin, Inc41d752cb-3866-e840-e063-6394a90acc372025-12-09WarningsExact identifier
application number: M016
Earths Care EczemaOATMEALDLC Laboratories, Inc.f72e2adf-8930-458f-a6cc-9b240b2f5eba2025-12-08WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Sparkling GrapefruitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company4575ba40-009c-26e0-e063-6394a90adee62025-12-08WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Chai CinnamonCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company4576cd28-9531-4db4-e063-6394a90a9fd32025-12-08WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin ProtectantCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companybeb22d69-8a83-65dc-e053-2a95a90ad8122025-12-08WarningsExact identifier
application number: M016
Medicated Hemorrhoidal PadsWITCH HAZELCardinal Health0b49db40-7abc-4e62-b6da-4b9f5b0ae16d2025-12-05WarningsExact identifier
application number: M016
CVS Health MedicatedWITCH HAZELCVS Pharmacya74ab253-cafc-4f00-9b8f-e5c1e6e7f2212025-12-05WarningsExact identifier
application number: M016
Major Medi-PadsWITCH HAZELMajor Pharmaceuticalsd2a314a2-98ab-4ac0-9e90-1a8c1303958f2025-12-05WarningsExact identifier
application number: M016
Good Sense MedicatedWITCH HAZELGeiss, Destin & Dunn, Inc5f122db5-4391-4957-9c25-76834c356c4f2025-12-05WarningsExact identifier
application number: M016
Witch HazelMEDICATED HEMORRHOIDAL WIPESGiant Eaglecdd9d6b7-cbc9-2839-e053-2a95a90ada002025-12-05WarningsExact identifier
application number: M016
Cool ComfortORGANIC WITCH HAZELNaticura Incde14c19c-56b5-4727-9194-94e85425ca8a2025-12-05WarningsExact identifier
application number: M016
GOODSENSE Maximum Strength MedicatedWITCH HAZELGEISS, DESTIN & DUNN, INC5453a12b-e775-4101-bd3a-337857e9e1672025-12-05WarningsExact identifier
application number: M016
Medicated Multipurpose WipesWITCH HAZELQUEST USA CORP.0f28d5f9-b20a-ac6f-e063-6394a90ac2082025-12-05WarningsExact 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