Evereden Intensive Eczema Balm

Product NDC
72113-109
11-digit product format
721130109
Labeler code
72113
Product ID
72113-109_2243d4ca-5ca5-54d0-e063-6394a90a3940
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Eden Brands Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-18
Substance
OATMEAL
Active strength
2 g/100g
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
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Evereden Intensive Eczema Balm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1486142Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2243d4ca-5ca4-54d0-e063-6394a90a3940Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72113-109-21Evereden Intensive Eczema Balm45 g in 1 JAROINTMENT451
72113-109-21Evereden Intensive Eczema Balm1 in 1 CARTONOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72113-109EVEREDEN INTENSIVE ECZEMA BALM (COLLOIDAL OATMEAL) OINTMENT [EDEN BRANDS INC.]1Current NDC, 2 package rows20241119_2243d4ca-5ca4-54d0-e063-6394a90a3940.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 66 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Petrolatum JellyPETROLATUMNEW PRIDE CORPf6634410-fa1f-7987-e053-2995a90abb062023-12-01WarningsExact identifier
application number: M016
Cetaphil Cracked Skin Repair BalmDIMETHICONEGalderma Laboratories, L.P.5efb3ef0-6ee9-4ef8-b81e-90bd1825c9562023-11-30WarningsExact identifier
application number: M016
Cetaphil Cracked Skin RepairDIMETHICONEGalderma Laboratories, L.P.27d74e0f-8359-4c59-bf7f-acade7f4545c2023-11-30WarningsExact identifier
application number: M016
Sheffield Advanced Scar GelADVANCED SCAR GELSheffield Pharmaceuticals LLCab78b946-81ed-442c-a167-26c26c7fe8a12023-11-30WarningsExact identifier
application number: M016
Akin Diaper RashZINC OXIDESouthern Sales & Service, Inc.f5515517-7977-48f9-aab6-cf0d2f2a04a02023-11-29WarningsExact identifier
application number: M016
Dr. Sheffield Diaper RashZINC OXIDESheffield Pharmaceuticals LLCcac77320-b5cf-4edf-9693-ebabfb61390c2023-11-28WarningsExact identifier
application number: M016
Sheffield Zinc OxideZINC OXIDESheffield Pharmaceuticals LLC60b54c04-4387-4954-951d-1658099473102023-11-28WarningsExact identifier
application number: M016
Cetaphil Baby Soothe and Protect CreamALLANTOINGalderma Laboratories, L.P.38254e03-3716-4e45-86b7-06430ebadc862023-11-22WarningsExact identifier
application number: M016
Cetaphil Baby Eczema SoothingCOLLOIDAL OATMEALGalderma Laboratories, L.P.d18aa7a8-15e3-4ca0-a501-fd11e8f7d85b2023-11-22WarningsExact identifier
application number: M016
EczemaHoneyBodyLotionCOLLOIDAL OATMEALAllure Labs0a710be0-562e-8368-e063-6294a90a3b1b2023-11-18WarningsExact identifier
application number: M016
Zinc OxideSKIN PROTECTANTBluePoint Laboratoriesd9b752e6-655a-19a6-e053-2995a90a9a372023-11-17WarningsExact identifier
application number: M016
UNIVERSAL ORIGINAL PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLC47b8c720-ad1e-4ac7-ba73-872e409b38bf2023-11-17WarningsExact identifier
application number: M016
UNIVERSAL LAVENDER SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLC1ac9ee69-339d-4426-b3bf-13e5386f1a9b2023-11-17WarningsExact identifier
application number: M016
UNIVERSAL COCOA BUTTER SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLCcf888bf3-6950-43aa-b4be-5a32961b4d962023-11-15WarningsExact identifier
application number: M016
UNIVERSAL BABY FRESH SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLCb6e0ddb8-3761-482a-83d0-15d612d142eb2023-11-15WarningsExact identifier
application number: M016
DERMA SANTE Anti Eczema CreamOATMEALHope Science Inc.1492a6ad-016c-4307-8286-5c564de9e1602023-11-11WarningsExact identifier
application number: M016
M3 NATURALS Eczema CreamOATMEALM3 Naturals LLC45e2cdde-58fb-4eea-a54d-f53f9ad0d8542023-11-11WarningsExact identifier
application number: M016
THERAPLEX Eczema TherapyOATMEALTHERAPLEX, LLC53900588-5c9e-4164-816d-017bdbb0f31b2023-11-11WarningsExact identifier
application number: M016
Boudreauxs Butt Diaper Rash Max StrengthZINC OXIDEGeodis Logistics LLC1b4fd6cb-f2dc-40a2-b958-e99caec917932023-11-10WarningsExact identifier
application number: M016
Boudreauxs Butt Diaper Rash OriginalZINC OXIDEGeodis Logistics LLC97587458-4ca0-4de3-9bb9-148346d859c02023-11-10WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1486142colloidal oatmeal 2 % Topical OintmentPSN2243d4ca-5ca4-54d0-e063-6394a90a39401
1486142colloidal oatmeal 0.02 MG/MG Topical OintmentSCD2243d4ca-5ca4-54d0-e063-6394a90a39401
1486142colloidal oatmeal 2 % Topical OintmentSY2243d4ca-5ca4-54d0-e063-6394a90a39401
1486142colloidal oatmeal 2 % Topical StickSY2243d4ca-5ca4-54d0-e063-6394a90a39401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72113-109-21721130109211 JAR in 1 CARTON (72113-109-21) / 45 g in 1 JAR1 jar2024-11-18NoNoCurrent