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 |
|---|---|---|---|---|---|---|
| Colloidal oatmeal | COLLOIDAL OATMEAL | CVS Pharmacy, Inc. | 4a43b1a2-2156-e490-e063-6294a90a6f84 | 2026-04-07 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE 8%, ZINC OXIDE 8% | Farmacias De Similares TX LLC | 4ecd0add-11c9-cf3b-e063-6394a90adff6 | 2026-04-06 | Warnings | M016 |
| Petroleum | WHITE PETROLATUM | CVS Pharmacy, Inc. | 4dc08832-e610-4e62-a6af-cadaa339e39e | 2026-04-06 | Warnings, Adverse reactions | M016 |
| Witch Hazel | WITCH HAZEL SPRAY | CVS Pharmacy | 53db78a8-eb2d-431b-84c1-73e99bb9d3d1 | 2026-04-06 | Warnings | M016 |
| Petroleum | WHITE PETROLATUM | Amazon.com Services LLC | 616ef87d-1518-46aa-8e12-9a1b678d4980 | 2026-04-06 | Warnings, Adverse reactions | M016 |
| Stabilizing Repair Serum | OATMEAL | Dermalogica, LLC. | 86b7b230-5424-46d3-8058-656f5172fc70 | 2026-04-02 | Warnings | M016 |
| calamine | CALAMINE AND ZINC OXIDE | STRATEGIC SOURCING SERVICES | 4e6a7bdf-4ef1-65e2-e063-6394a90ae124 | 2026-04-01 | Warnings | M016 |
| Aveeno Eczema Therapy Rescue Relief Treatment Gel Cream | COLLOIDAL OATMEAL | Kenvue Brands LLC | 4e4e1797-26e6-a67b-e063-6294a90af438 | 2026-03-31 | Warnings | M016 |
| Target Advanced Scar Gel | ADVANCED SCAR GEL | Target Corporation | 86c215fe-aad4-45d1-bdb7-cde00a115c5c | 2026-03-31 | Warnings | M016 |
| Zinc oxide, Dimethicone | ZINC OXIDE, DIMETHICONE | Walmart Inc. | 4cbf9492-33cd-e6d4-e063-6294a90ab001 | 2026-03-31 | Warnings, Adverse reactions | M016 |
| Critic-Aid Clear | PETROLATUM | Coloplast Corp | a92c18f7-52b2-43e4-bae3-2bab9de22671 | 2026-03-31 | Warnings | M016 |
| 3M Cavilon Durable Barrier | DIMETHICONE | Solventum US LLC | f3f8be33-4ad2-4f5f-ac94-ddfbe0280b83 | 2026-03-31 | Warnings | M016 |
| XIMONTH Foot Sanitizer | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 4e38d24d-3745-c121-e063-6394a90abbb5 | 2026-03-30 | Warnings | M016 |
| Dynashield | ZINC OXIDE | Dynarex Corporation | 59fd865c-b81d-43ad-8fa0-c37ca0557769 | 2026-03-30 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant | COLLOIDAL OATMEAL | Port Jervis Laboratories, Inc | 4e43b65c-d5bb-f228-e063-6294a90ad08d | 2026-03-30 | Warnings | M016 |
| ChapStick Classic Original | SKIN PROTECTANT LIP BALM | Suave Brands Co., LLC | 4275956d-275a-4e31-e063-6394a90a78d3 | 2026-03-30 | Warnings | M016 |
| ChapStick Classic Cherry | SKIN PROTECTANT LIP BALM | Suave Brands Co., LLC | 42762471-e5cd-505e-e063-6294a90afb7d | 2026-03-30 | Warnings | M016 |
| ChapStick Classic Variety Cherry-Strawberry-Spearmint | SKIN PROTECTANT LIP BALM | Suave Brands Co., LLC | 450e46d2-de86-e5fa-e063-6294a90ac6ff | 2026-03-30 | Warnings | M016 |
| ChapStick Classic Original | SKIN PROTECTANT LIP BALM | Suave Brands Co., LLC | 4512220a-9fc2-8816-e063-6394a90a9d15 | 2026-03-30 | Warnings | M016 |
| ChapStick Classic Original Military | SKIN PROTECTANT LIP BALM | Suave Brands Co., LLC | 45136b7e-136b-0283-e063-6394a90a599a | 2026-03-30 | 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 |