FDA.reportPublic FDA data

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 67 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EltaMD Laser BalmPETROLATUM SKIN PROTECTANTCP Skin Health Group, Inc1c67ce72-89d9-4c4f-a9b0-28b7e67d30eb2023-11-09WarningsExact identifier
application number: M016
DiaperDerm Diaper RashZINC OXIDEDiaperderm Inc4e1fce3e-c2b7-42da-9953-1dbb13e2467c2023-11-06WarningsExact identifier
application number: M016
Doctors Diaper Rash CreamZINC OXIDEDOCTOR'S DIAPER RASH CREAM, INC0988ccb1-7881-4d97-bcbf-d0cf4316e4be2023-11-06WarningsExact identifier
application number: M016
DERMOIA Manuka Honey Eczema CreamOATMEALTREASUREWISE LLCa48e52a3-b681-4489-a1fd-6b09d8bc9c552023-11-06WarningsExact identifier
application number: M016
GL HEALTH Barrier Skin ProtectantZINC OXIDEGL HEALTH, INC.76cfa330-fea9-48d4-b187-469154765d392023-11-06WarningsExact identifier
application number: M016
Skin-lubePETROLATUM, DIMETHICONEThe Hygenic Company, LLC.d1005dec-04f6-3f88-e053-2a95a90ad9cb2023-11-05WarningsExact identifier
application number: M016
Dr. Sheffield Anti Itch CreamANTI ITCH CREAMSheffield Pharmaceuticals LLC77f0593e-f694-4c02-9fd9-ad56ff2a920c2023-10-30WarningsExact identifier
application number: M016
calahistCALAMINE AND PRAMOXINE HYDROCHLORIDEWALGREEN COMPANYfed45e06-cc53-fbc5-e053-6294a90a1b192023-10-27WarningsExact identifier
application number: M016
calahist clearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEWALGREEN COMPANYfed469c2-fe13-6726-e053-6394a90a5f512023-10-27WarningsExact identifier
application number: M016
Dr. Sayman SalveSALVESheffield Pharmaceuticals LLC18bdcd0c-9c81-47e1-ae24-2239ff8fd0662023-10-24WarningsExact identifier
application number: M016
Theriac Advanced HealingLANOLINSheffield Pharmaceuticals LLCc780cd27-dc9e-45f3-97f0-e59b1b6b955a2023-10-24WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper RashZINC OXIDEBabo Botanicals, Inc.d66e369e-9b19-b084-e053-2995a90aa2592023-10-23WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby HealingCOLLOIDAL OATMEALBabo Botanicals, Inc.08659a5c-2d10-2f98-e063-6394a90a77602023-10-23WarningsExact identifier
application number: M016
White Rose Petroleum JellyPETROLATUMJ. Strickland & Co.1aeb090d-c103-4c2e-accc-d9d248315db92023-10-21WarningsExact identifier
application number: M016
Tricalm HydrogelALUMINUM ACETATEMODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES082c6441-be47-4466-e063-6394a90ad5002023-10-20WarningsExact identifier
application number: M016
EmpowerWHITE PETROLATUM, ZINC OXIDEBemis Manufacturing Company Inc08006b60-966b-155b-e063-6294a90a206a2023-10-18WarningsExact identifier
application number: M016
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
application number: M016
AnubisMedSODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREAANUBIS COSMETICS SLebf4b3ab-34e1-185a-e053-2a95a90ace3a2023-09-05WarningsExact identifier
application number: M016
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaDMAEANUBIS COSMETICS SLf22b212d-d21d-5984-e053-2995a90a683e2023-09-01WarningsExact 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