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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 71564-004 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 71564-004 | 71564-004-05 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 71564-004 | 71564-004-07 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 71564-004 | 71564-004-08 | D | Discontinued by firm | 2026-10-15 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71564-004-07 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71564-004-08 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71564-004-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71564-004-07 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71564-004-08 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71564-004-05 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71564-004-07 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71564-004-08 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71564-004-07 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71564-004-08 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71564-004-07 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71564-004-08 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71564-004-07 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71564-004-08 | cdf11ea48f46… | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Herpecin Pain Relief | ALLANTOIN, BENZETHONIUM CHLORIDE, LIDOCAINE HCL | Focus Consumer Healthcare, LLC | beeb6043-6547-4fe9-e053-2995a90a5d74 | 2026-04-30 | Warnings | M016 |
| CVS | PETROLATUM | Apollo Health and Beauty Care | 47d2b9be-91ad-e9e2-e063-6294a90ac29f | 2026-04-30 | Warnings | M016 |
| Dr. Numb | LIDOCAINE | Shinpharma Inc | 0578fbcb-875a-4606-acde-dcecb29756e6 | 2026-04-30 | Warnings | M016 |
| Colloidal oatmeal | COLLOIDAL OATMEAL | Amazon.com Services LLC | 423c821d-92af-47f0-b9ee-8b68ecbcc44e | 2026-04-29 | Warnings, Adverse reactions | M016 |
| MICRO INFUSIONSYSTEM | SEEK GLO | Ningbo Kenwei International Trade Co., Ltd. | 50746cab-bfcc-fe0b-e063-6394a90adc01 | 2026-04-27 | Warnings | M016 |
| Pharmacy Choice | MENTHOL, ZINC OXIDE | PHARMACY CHOICE INC | 5031fc05-e1c7-40b1-e063-6394a90aa12c | 2026-04-24 | Warnings | M016 |
| Sel pH baby PH-BALANCED ECZEMA DRYNESS BABYLOTION | SEL PH BABY PH-BALANCED ECZEMA DRYNESS BABY | Guangzhou Ariel Biotech Co., Ltd. | 5040b707-87af-3859-e063-6294a90afb3d | 2026-04-24 | Warnings | M016 |
| Caldesene Baby | STARCH, CORN AND ZINC OXIDE | Insight Pharmaceuticals LLC | 9f12dee2-7afa-45e9-a729-0fd42bb77715 | 2026-04-22 | Warnings | M016 |
| Caldesene Medicated Protecting | CORNSTARCH AND ZINC OXIDE | Insight Pharmaceuticals LLC | ffc92a0f-a7cf-4a46-b2f1-089df2bbb96b | 2026-04-22 | Warnings | M016 |
| Arm and Hammer Baking Soda | SODIUM BICARBONATE | Church & Dwight Co., Inc. | 643fe204-4a7b-00e4-e053-2a91aa0aef06 | 2026-04-21 | Warnings | M016 |
| PURE PETROLATUM | PETROLATUM | MY IMPORTS USA LLC | 4fba8bc7-590d-f621-e063-6294a90ad8c9 | 2026-04-18 | Warnings | M016 |
| Anti-Itch Regular Strength | HYDROCORTISONE | CVS Pharmacy | 9fe7768b-9023-c9ee-e053-2a95a90a55b3 | 2026-04-17 | Warnings | M016 |
| Calamine Clear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION | Pharma Nobis, LLC | 4f853183-5925-2c73-e063-6394a90adf6c | 2026-04-15 | Warnings | M016 |
| Freskaro Calamine Plus | ZINC OXIDE LOTION | Pharma Nobis, LLC | 4f85bdc7-8fed-f1f5-e063-6394a90a6358 | 2026-04-15 | Warnings | M016 |
| Zinc Oxide | ZINC OXIDE OINTMENT | Dynarex Corporation | 11d79dd6-35f7-4399-e063-6294a90ac7dd | 2026-04-13 | Warnings | M016 |
| FB HYDRATING HAND SANITIZER | FB HYDRATING HAND SANITIZER | FAMILY DOLLAR SERVICES, LLC | 4f261746-37e9-7b30-e063-6294a90a9224 | 2026-04-10 | Warnings | M016 |
| FB HYDRATING HAND SANITIZER | FB HYDRATING HAND SANITIZER | FAMILY DOLLAR SERVICES, LLC | 4f268501-6cd7-7edd-e063-6294a90ac649 | 2026-04-10 | Warnings | M016 |
| BEVERLY HILLS MD HYDRARESCUE TREATMENT | DIMETHICONE | Beverly Hills MD, LLC | 4ed33a43-d059-2589-e063-6294a90a30b3 | 2026-04-09 | Warnings | M016 |
| Petroleum Jelly | WHITE PETROLATUM | WAL-MART STORES INC | 00faa772-53f3-9276-e063-6394a90a2dab | 2026-04-07 | Warnings | M016 |
| ProCure Zinc Oxide | ZINC OXIDE | Twin Med LLC | 37a30ee5-fd33-b410-e063-6294a90aef72 | 2026-04-07 | Warnings | M016 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71564-004-05 | 71564000405 | 142 g in 1 TUBE (71564-004-05) | 142 g | 2022-08-08 | 0000-00-00 | No | No | Current |
| 71564-004-07 | 71564000407 | 7 g in 1 TUBE (71564-004-07) | 7 g | 2020-08-06 | 0000-00-00 | Yes | No | Current |
| 71564-004-08 | 71564000408 | 227 g in 1 TUBE (71564-004-08) | 227 g | 2020-07-01 | 0000-00-00 | No | No | Current |