M3 NATURALS Eczema Cream

Product NDC
81985-186
11-digit product format
819850186
Labeler code
81985
Product ID
81985-186_09e2e2ce-d85c-0711-e063-6294a90a9213
Type
HUMAN OTC DRUG
Nonproprietary name
OATMEAL
Dosage form
CREAM
Route
TOPICAL
Labeler
M3 Naturals LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-19
Substance
OATMEAL
Active strength
10 mg/mL
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
M3 NATURALS Eczema Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL10 mg/mL

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
240651Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
45e2cdde-58fb-4eea-a54d-f53f9ad0d854Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81985-186-012023-11-11C16284748780-1f386c64a-2ed2-0266-e053-dadaa90a7c1aM3 NATURALS: Eczema Cream
81985-186-012023-01-30C16284748780-1f386c64a-2ed2-0266-e053-dadaa90a7c1aM3 NATURALS: Eczema Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81985-186-01M3 NATURALS Eczema Cream118 mL in 1 JARCREAM1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81985-186M3 NATURALS ECZEMA CREAM (OATMEAL) CREAM [M3 NATURALS LLC]2Current NDC, Legacy NDC, 1 package rows20231112_45e2cdde-58fb-4eea-a54d-f53f9ad0d854.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 65 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEB CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d579680-6bcb-1161-e053-2991aa0aead12023-12-18WarningsExact identifier
application number: M016
Publix Clear Anti-ItchZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6b905f-ed30-1ab7-e053-2a91aa0a816b2023-12-18WarningsExact identifier
application number: M016
Humco CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEHumco Holding Group, Inc.5fca3a73-6d66-496b-bd33-6e044f9039bc2023-12-15WarningsExact identifier
application number: M016
Calamine Phenolated Topical SuspensionCALAMINE AND ZINC OXIDE AND PHENOLHumco Holding Group, Inca3816729-be2b-4b4f-a609-953576cd2e3b2023-12-15WarningsExact identifier
application number: M016
Humco Mineral Oil LightMINERAL OILHumco Holding Group, Inc.753f35c3-1420-4817-ba63-b737a9c99a1d2023-12-15WarningsExact identifier
application number: M016
Humco Witch HazelWITCH HAZELHumco Holding Group, Inc.3cf07016-a129-49ca-8fad-b67dda5aa0092023-12-15WarningsExact identifier
application number: M016
Rite Aid CalamineCALAMINE 8% AND ZINC OXIDE 8%Rite Aid Corporation5df71189-9b36-9dee-e053-2a91aa0a9e492023-12-15WarningsExact identifier
application number: M016
GNP Witch HazelWITCH HAZELAmerisource Bergen45ac839d-215d-4c5f-8ae5-5e111d1700612023-12-14WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin ProtectantGLYCERINL'Oreal USA Products Inc32eaaaab-41bd-4efe-a71d-92e3a702c1e52023-12-11WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Lipikar Eczema ReliefOATMEALCOSMETIQUE ACTIVE PRODUCTIONe555de17-9b42-4125-a17b-467bc1d179d72023-12-11WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing ReliefOATMEALL'Oreal USA Products Incf7b71606-0044-4729-82e8-4514331806a02023-12-11WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5GLYCERINCosmetique Active Production01c8a0d5-bcd1-4639-be45-530a226401f02023-12-11WarningsExact identifier
application number: M016
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.0bc6812a-5c2a-7bb9-e063-6294a90a36e32023-12-05WarningsExact identifier
application number: M016
Carmex Classic Lip Balm Medicated Free Strawberry Stick Sunscreen SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.34fae56e-367d-4659-af2d-1c9ddaf1639c2023-12-05WarningsExact identifier
application number: M016
Diaper Rash Cream 2.5ozZINC OXIDERejoice International Corp.0ba98cdf-489e-dc2a-e063-6294a90adb382023-12-04WarningsExact identifier
application number: M016
Diaper Rash Cream 2.5ozZINC OXIDEChina Ningbo Shangge Cosmetics Technology Corp.0baa8a14-8655-d77c-e063-6294a90ab8aa2023-12-04WarningsExact identifier
application number: M016
THERAPLEX Eczema TherapyOATMEALTHERAPLEX, LLC86472a3d-7138-4141-8422-ab20c17a46e02023-12-04WarningsExact identifier
application number: M016
SOOTHE Moisturizing Rescue CreamOATMEALRodan & Fields91163267-c2aa-47b3-b290-d1605536d8062023-12-04WarningsExact identifier
application number: M016
Manzatin-E Diaper Rash Skin ProtectantZINC OXIDELaboratorios Zepol S.A.cafd084f-8493-4d6e-b256-2d4b4282f8662023-12-01WarningsExact identifier
application number: M016
Manzatin Diaper Rash Skin ProtectantZINC OXIDELaboratorios Zepol S.A.5c1618a4-ca08-4814-a556-74e79db618b92023-12-01WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240651colloidal oatmeal 1 % Topical CreamPSN45e2cdde-58fb-4eea-a54d-f53f9ad0d8542
240651colloidal oatmeal 10 MG/ML Topical CreamSCD45e2cdde-58fb-4eea-a54d-f53f9ad0d8542
240651Avena sativa 1 % Topical CreamSY45e2cdde-58fb-4eea-a54d-f53f9ad0d8542
240651colloidal oatmeal 1 % Topical CreamSY45e2cdde-58fb-4eea-a54d-f53f9ad0d8542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81985-186-0181985018601118 mL in 1 JAR (81985-186-01) 118 ml2021-04-190000-00-00NoNoCurrent