OKeeffes Eczema Relief

Product NDC
71564-004
11-digit product format
715640004
Labeler code
71564
Product ID
71564-004_e5c2343d-c47c-9c1d-e053-2a95a90a1d3c
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
CREAM
Route
TOPICAL
Labeler
The Gorilla Glue Company/O'Keeffe's Company
Application
M016
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-07-01
Marketing end
0000-00-00
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
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71564-004DDiscontinued by firm2026-10-15
excluded packagepackage71564-00471564-004-05DDiscontinued by firm2026-10-15
excluded packagepackage71564-00471564-004-07DDiscontinued by firm2026-10-15
excluded packagepackage71564-00471564-004-08DDiscontinued by firm2026-10-15

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 · 16 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 packagepackage71564-004-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71564-004-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71564-004-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71564-004-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71564-004-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71564-004-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71564-004-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71564-004-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71564-004-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71564-004-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71564-004-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71564-004-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71564-004-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71564-004-08cdf11ea48f46…ba0047e9e063…

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 11 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daily MoisturizingDIMETHICONEAldi, Inc118a1a07-7283-4353-97b5-6ac3b1cc14302026-05-08Warnings, Adverse reactionsExact identifier
application number: M016
DoveANTIBACTERIAL CARE MOISTURIZING CREAMConopco Inc. d/b/a/ Unilever5150f48c-ff0c-ce39-e063-6394a90ad4242026-05-08WarningsExact identifier
application number: M016
Seedlings Diaper Rash CreamZINC OXIDEYoung Living Essential Oils, LC.4d8aeaba-ddb1-6f74-e054-00144ff88e882026-05-08WarningsExact identifier
application number: M016
Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.5120b708-047a-1182-e063-6394a90a74c32026-05-06WarningsExact identifier
application number: M016
AOAO Acne Buster Salicylic Acid Drying SerumZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.Guangzhou Senmai Biotechnology Co.,Ltd.512185a5-5c1d-ef9f-e063-6394a90a81af2026-05-06WarningsExact identifier
application number: M016
AKOLKOL TOENAIL FUNGUS TREATMENTGLYCERINShantou Ximonth Biotechnology Co., Ltd.5121c341-e5e9-2b36-e063-6394a90a93b82026-05-06WarningsExact identifier
application number: M016
Beyond Good Diaper RashZINC OXIDEBabylist, Inc512b62df-4f08-d839-e063-6294a90ab52f2026-05-06WarningsExact identifier
application number: M016
Acne Buster Salicylic Acid Drying SerumZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.Guangzhou Senmai Biotechnology Co.,Ltd.4c531280-bc5b-1cf2-e063-6394a90a034a2026-05-05WarningsExact identifier
application number: M016
PEGO Acne Buster Salicylic Acid Drying SerumZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.Guangzhou Senmai Biotechnology Co.,Ltd.511eaced-c4d8-ae94-e063-6394a90a320e2026-05-05WarningsExact identifier
application number: M016
Rugby Gas reliefSIMETHICONERugby Laboratories9b84f74f-8609-489d-b411-3103afa1b5c22026-05-04WarningsExact identifier
application number: M016
Vitamin A and DPETROLATUMAldermed Inc.3f13a15c-8b64-48f0-a459-853b9097bc312026-05-04WarningsExact identifier
application number: M016
Zinc Oxide Skin ProtectantZINC OXIDE 20%Aldermed Inc.a55ac5b4-bac7-4d2a-8ac8-c3eaf7e89e522026-05-04WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMAldermed Inc.4e02af41-db86-46d8-a97d-332d84eced6f2026-05-04WarningsExact identifier
application number: M016
Daily MoisturizerLOTIONWalgreensfc65f673-b23d-1ffa-e053-6394a90a09662026-05-03WarningsExact identifier
application number: M016
Dry Skin HealingPETROLATUMWalgreen0397507d-4b6e-c679-e063-6294a90a0b332026-05-03WarningsExact identifier
application number: M016
Daily MoisturizerLOTIONWalgreenfc67037a-ed31-f678-e053-6394a90a71752026-05-03WarningsExact identifier
application number: M016
Skin ReliefLOTIONWalgreenfc678e80-e63d-e3fe-e053-6394a90aa7d62026-05-03WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMWalmart INCf76ceecc-ef11-3839-e053-6394a90a8d4a2026-05-03WarningsExact identifier
application number: M016
Herpecin LDIMETHICONE AND MERADIMATE AND OCTINOXATE AND OCTISALATE AND OXYBENZONEFocus Consumer Healthcare, LLC5b6ed4e9-3e69-c773-e053-2991aa0a7dfe2026-05-01WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDRetail Business Services, LLC7291e175-a9b6-4c47-93ce-227ce11e45992026-04-30Warnings, Adverse reactionsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71564-004-0571564000405142 g in 1 TUBE (71564-004-05) 142 g2022-08-080000-00-00NoNoCurrent
71564-004-07715640004077 g in 1 TUBE (71564-004-07) 7 g2020-08-060000-00-00YesNoCurrent
71564-004-0871564000408227 g in 1 TUBE (71564-004-08) 227 g2020-07-010000-00-00NoNoCurrent