Eczema

Product NDC
73517-425
11-digit product format
735170425
Labeler code
73517
Product ID
73517-425_ec9769f6-68e7-7c92-e053-2a95a90a0bf6
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
LOTION
Route
TOPICAL
Labeler
Amyris, Inc
Application
M016
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-02-01
Marketing end
0000-00-00
Substance
OATMEAL
Active strength
1 g/100mL
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
2023-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

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

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 40 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EIGHT HOUR SKIN FRAGRANCE FREEPETROLATUMREVLONb61d6e2e-18dd-37d2-e053-2a95a90af57b2025-08-01WarningsExact identifier
application number: M016
Vigority Wild Yam CreamESTRIOL CREAMFOUNDATION COMMERCE INC39b2bef7-46c5-9ad5-e063-6294a90ae9832025-07-30WarningsExact identifier
application number: M016
Rugby Caldyphen ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONRugby Laboratories9af3a740-ef97-26ce-e053-2a95a90a0ee12025-07-28WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy Soothing Bath TreatmentOATMEALKenvue Brands LLCe7eb10b7-3950-49cb-ba73-11e7581b6be92025-07-25WarningsExact identifier
application number: M016
ProCure SkinGuardPETROLATUM 49.9%Twin Med LLC3a1721f6-1bb0-cd47-e063-6394a90a148e2025-07-25WarningsExact identifier
application number: M016
ProCure HydroCerinPETROLATUM 33%Twin Med LLC3ab7248d-b914-9fdd-e063-6294a90ac4c82025-07-24WarningsExact identifier
application number: M016
AD PREVENT OriginalAD PREVENT ORIGINALWellSpring Pharmaceutical Corporationcf73246e-81c1-42e9-a107-dc6c99cf7d012025-07-24WarningsExact identifier
application number: M016
Dimethicone 1 Skin ProtectantDIMETHICONEUniversal Distribution Center LLC2c5b96b9-24d6-4223-a63d-fe83d7c023682025-07-24WarningsExact identifier
application number: M016
Dr Butlers Soothing IncontinenceMINERAL OIL 59.8%, PETROLATUM 36.0%Beyond Health PA3a9d3796-fd05-fe57-e063-6294a90a0ac62025-07-23WarningsExact identifier
application number: M016
A and D plus EVITAMIN A, D AND E OINTMENTDerma Sciences Canada Inc.35aca592-bfd0-652f-e063-6394a90ac53e2025-07-22WarningsExact identifier
application number: M016
Petroleum JellyPETROLATUMDerma Sciences Canada Inc.3a895e6c-da8d-db9b-e063-6394a90ace402025-07-22WarningsExact identifier
application number: M016
Petroleum JellyPETROLEUM JELLYNeilMed Pharmaceuticals Inc.36bbbb1e-78e9-98f6-e063-6294a90a66d12025-07-21WarningsExact identifier
application number: M016
Mountain Ice EczemaCOLLOIDAL OATMEALMountainside Medical Equipment, Inc.1a91f33e-dd85-4d5a-b61c-e460a507e2922025-07-21WarningsExact identifier
application number: M016
Our Eczema RemedyCOLLOIDAL OATMEALFewer Better Things3a755b4c-47c8-9ca5-e063-6394a90af84a2025-07-21WarningsExact identifier
application number: M016
Aveeno DAILY MOISTURIZINGDIMETHICONEKenvue Brands LLC54a13b85-32b5-439d-a27a-8fba2cf442512025-07-16WarningsExact identifier
application number: M016
ProCure Moisture Barrier1% DIMETHICONE, 12% ZINC OXIDETwin Med LLC3988c83b-d4eb-1f09-e063-6394a90a45ad2025-07-14WarningsExact identifier
application number: M016
Avalon Organics Antidandruff ConditionerSALICYLIC ACIDThe Hain Celestial Group, Inc.66db1071-022a-aa19-e053-2a91aa0a8e392025-07-11WarningsExact identifier
application number: M016
Avalon Organics AntidandruffSALICYLIC ACIDThe Hain Celestial Group, Inc.66c7f730-64f3-4eef-e053-2a91aa0a42252025-07-11WarningsExact identifier
application number: M016
terrasil Infection Protection Wound Care Maximum StrengthALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions9e7843e2-ca69-40f5-a4ce-da6b03ebe7f72025-07-11WarningsExact identifier
application number: M016
terrasil Skin RepairALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions92a23c7f-6b89-49cb-93e2-49ab7a85c86d2025-07-11WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73517-425-01735170425011 TUBE in 1 CARTON (73517-425-01) > 177 mL in 1 TUBE1 tube2021-02-010000-00-00NoNoCurrent
73517-425-027351704250230 mL in 1 TUBE (73517-425-02) 30 ml2021-02-010000-00-00NoNoCurrent