Kids Eczema

Product NDC
82960-245
11-digit product format
829600245
Labeler code
82960
Product ID
82960-245_e932aa34-c461-b6ed-e053-2a95a90a2b3a
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
CREAM
Route
TOPICAL
Labeler
Rosemont Ventures, Inc.
Application
M016
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-09-15
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct82960-245DDiscontinued by firm2026-10-21
excluded packagepackage82960-24582960-245-01DDiscontinued by firm2026-10-21

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage82960-245-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage82960-245-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage82960-245-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage82960-245-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage82960-245-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage82960-245-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage82960-245-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage82960-245-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage82960-245-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage82960-245-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage82960-245-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage82960-245-01557ba5c1ecfa…9c80585c8c6e…

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 39 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmeriDerm Vitamin A DWHITE PETROLATUMShield Line LLCb73a8fc9-fa00-774a-e053-2995a90afd1e2025-08-15WarningsExact identifier
application number: M016
Baby Petrolatum JellyPETROLATUMSHIELD LINE LLC35c163e6-ae41-2791-e054-00144ff8d46c2025-08-15WarningsExact identifier
application number: M016
MedPride EN SHIELD ALOE SOFT VITAMIN ENRICHEDZINC OXIDEShield Line LLC890ba245-ef37-4c62-ae82-980cb78acfb62025-08-15WarningsExact identifier
application number: M016
Earth Mama Eczema CreamCOLLOIDAL OATMEALEarth Mama Angel Baby, LLCbd30b525-f68c-4786-9fbc-745e2634c6bb2025-08-12WarningsExact identifier
application number: M016
Vitacilina Bebe Diaper RashZINC OXIDETaisho Pharmaceutical California Inc.6701e929-700e-40a4-9117-81e36577bfe12025-08-07WarningsExact identifier
application number: M016
Durma DynaGelDURMA DYNAGELDynarex Corporation3bcbe314-98ca-78f1-e063-6394a90a13ad2025-08-07WarningsExact identifier
application number: M016
Bath Bomb 2-pack (Lemon)ALLANTOINCarolina Cannabis Creations LLC08c7c313-cf36-fb46-e063-6294a90a73042025-08-06WarningsExact identifier
application number: M016
Earthmed Lip Balm Strawberry RhubarbALLANTOINEarthmed LLC3b54eea1-2e09-2ee1-e063-6294a90a52e52025-08-05WarningsExact identifier
application number: M016
ProCure Skin Repair CreamDIMETHICONE 1.5%Twin Med LLC3ba3d3b3-ab13-ea80-e063-6394a90ad4592025-08-05WarningsExact identifier
application number: M016
Earthmed FS Hand and footALLANTOINEarthmed LLC3ba592e9-2ef1-d20a-e063-6394a90a9bae2025-08-05WarningsExact identifier
application number: M016
Earthmed FS massage oilALLANTOINEarthmed LLC3ba64ad2-61b1-8021-e063-6294a90a73352025-08-05WarningsExact identifier
application number: M016
Petroleum JellyBABY PETROLEUM JELLYNeilMed Pharmaceuticals Inc.3b861e02-671a-c9e5-e063-6394a90a8d0f2025-08-04WarningsExact identifier
application number: M016
Earthmed Sport massage oilALLANTOINEarthmed LLC3b92e87d-ba8d-4bac-e063-6294a90a106e2025-08-04WarningsExact identifier
application number: M016
EA EIGHT HOUR SKIN PROTECTANTPETROLATUMREVLONb590991c-8ec8-67c2-e053-2a95a90a3acf2025-08-01WarningsExact identifier
application number: M016
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82960-245-01829600245011 TUBE in 1 CARTON (82960-245-01) > 59 mL in 1 TUBE1 tube2022-09-150000-00-00NoNoCurrent