NDC 65112-250-01 - EczaCalm

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
65112-250
Requested NDC
65112-250-01
Package NDCs from labels
65112-250-01, 65112-250-02
Manufacturer
I Shay Cosmetics Inc
Effective date
2024-10-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
EczaCalm - I Shay Cosmetics IncI Shay Cosmetics Inc2024-10-08HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65112-250-022024-10-08C16284748780-11030e365-0a94-111a-e063-dadaa90a10e2EczaCalm Cream
65112-250-022024-01-30C16284748780-11030e365-0a94-111a-e063-dadaa90a10e2EczaCalm Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65112-250-01EczaCalm48.2 g in 1 TUBEOINTMENT48.25
65112-250-02EczaCalm1 in 1 BOXOINTMENT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65112-250ECZACALM (SKIN PROTECTANT) OINTMENT [I SHAY COSMETICS INC]5Legacy NDC, 2 package rows20241010_b9e51c5c-e4c9-ed0b-e053-2995a90ad193.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 12 of 12 · 234 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetaphil Baby Eczema SoothingCOLLOIDAL OATMEALGalderma Laboratories, L.P.d18aa7a8-15e3-4ca0-a501-fd11e8f7d85b2023-11-22WarningsExact identifier
unii: 8PI54V663Y
EczemaHoneyBodyLotionCOLLOIDAL OATMEALAllure Labs0a710be0-562e-8368-e063-6294a90a3b1b2023-11-18WarningsExact identifier
unii: 8PI54V663Y
DERMA SANTE Anti Eczema CreamOATMEALHope Science Inc.1492a6ad-016c-4307-8286-5c564de9e1602023-11-11WarningsExact identifier
unii: 8PI54V663Y
M3 NATURALS Eczema CreamOATMEALM3 Naturals LLC45e2cdde-58fb-4eea-a54d-f53f9ad0d8542023-11-11WarningsExact identifier
unii: 8PI54V663Y
THERAPLEX Eczema TherapyOATMEALTHERAPLEX, LLC53900588-5c9e-4164-816d-017bdbb0f31b2023-11-11WarningsExact identifier
unii: 8PI54V663Y
DERMOIA Manuka Honey Eczema CreamOATMEALTREASUREWISE LLCa48e52a3-b681-4489-a1fd-6b09d8bc9c552023-11-06WarningsExact identifier
unii: 8PI54V663Y
Babo Botanicals Sensitive Baby HealingCOLLOIDAL OATMEALBabo Botanicals, Inc.08659a5c-2d10-2f98-e063-6394a90a77602023-10-23WarningsExact identifier
unii: 8PI54V663Y
First Aid Beauty FAB Ultra Repair Skin Protectant Candy CaneCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companybec2f702-5ff5-ea66-e053-2a95a90ad1ec2023-01-01WarningsExact identifier
unii: 8PI54V663Y
Badger After-BUG BalmCOLLOIDAL OATMEALW.S. Badger Company, Inc.a623da47-cef2-146f-e053-2a95a90afe3a2021-11-17WarningsExact identifier
unii: 8PI54V663Y
LMNOOP Eczema Relief CreamLMNOOP ECZEMA RELIEF CREAMShenzhen Ishan Technology Co., Ltd52ecd5ef-91a1-4ad0-e063-6394a90ab5962020-11-01WarningsExact identifier
unii: 8PI54V663Y
Derma-e Eczema ReliefOATMEALTopiderm, Ince1797f81-af4b-49e1-9906-dbfd904a282b2020-08-19WarningsExact identifier
unii: 8PI54V663Y
Eczema Care Moisturizing 3 oz.COLLOIDAL OATMEALRejoice International Inc.83967d26-159a-e95c-e053-2991aa0af53a2019-03-08WarningsExact identifier
unii: 8PI54V663Y
MG217 Eczema FaceCOLLOIDAL OATMEALWisconsin Pharmacal Company5f10697e-7f0c-f2b7-e053-2991aa0aabde2017-11-30WarningsExact identifier
unii: 8PI54V663Y
MG217 Baby EczemaCOLLOIDAL OATMEALWisconsin Pharmacal Company5d65052d-2972-544d-e053-2a91aa0afa3e2017-11-28WarningsExact identifier
unii: 8PI54V663Y

Reported adverse events (FAERS/openFDA)#

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