First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant
- Product NDC
- 10637-1901
- 11-digit product format
- 106371901
- Labeler code
- 10637
- Product ID
- 10637-1901_4e43bf3d-2852-f801-e063-6294a90a8746
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Colloidal Oatmeal
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Port Jervis Laboratories, Inc
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-11-30
- Substance
- OATMEAL
- Active strength
- .5 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
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OATMEAL | .5 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8PI54V663Y | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1654149 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4e43b65c-d5bb-f228-e063-6294a90ad08d | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10637-1901-1 | First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant | 28.3 g in 1 TUBE | CREAM | 28.3 | 1 |
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 |
|---|---|---|---|---|---|---|
| Honest Eczema Balm | COLLOIDAL OATMEAL | The Honest Company, Inc. | 35b8bc5c-420e-4d31-9659-f36cabbd897a | 2024-05-14 | Warnings | M016 |
| Extra Strength Itch Stopping | ITCH STOPPING CREAM | Universal Distribution Centre LLC | b9a42aa3-1903-76f0-e053-2a95a90a51d1 | 2024-05-13 | Warnings | M016 |
| Calamine Clear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION | Cardinal Health, 110 dba Leader | 7f733c0a-82b2-d3b0-e053-2991aa0a6b0f | 2024-05-13 | Warnings | M016 |
| Walgreens Maximum Diaper Rash | ZINC OXIDE | Walgreens Company | 5eb2152f-6fa2-4191-878a-207416e69818 | 2024-05-07 | Warnings | M016 |
| Cetaphil Eczema Rapid Relief Cream | COLLOIDAL OATMEAL | Galderma Laboratories, L.P. | 02a405fa-8ae9-41e9-b86f-ef5fb6e3844a | 2024-05-02 | Warnings | M016 |
| Chapstick | AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM | Haleon US Holdings LLC | 0e34fc74-772e-48fd-a353-58807ef412c1 | 2024-05-01 | Warnings | M016 |
| Diaper Rash Cream 40% ZINC | ZINC OXIDE | ASTONEA LABS PRIVATE LIMITED | 16da985a-6210-ec82-e063-6294a90a132d | 2024-04-24 | Warnings | M016 |
| Petrolatum Jelly | PETROLATUM | ASTONEA LABS PRIVATE LIMITED | 16dac8e5-aeb8-592d-e063-6394a90ae2b6 | 2024-04-24 | Warnings | M016 |
| Monistat Complete Care Chafing Relief | DIMETHICONE | Insight Pharmaceuticals LLC | 07d7c883-1fa3-4786-905c-a1fab649765e | 2024-04-19 | Warnings | M016 |
| zinc oxide 20% | ZINC OXIDE 20% | Bionpharma Inc | 1549500a-0941-0fba-e063-6394a90a564e | 2024-04-18 | Warnings | M016 |
| ARC Skin Protectant | ALLANTOIN | Anjon Biologics, Inc | f4ff79dd-cb38-4cca-9631-a2758a171873 | 2024-04-18 | Warnings | M016 |
| Zinctral | ZINC OXIDE | PureTek Corporation | de990834-00da-0c7a-e053-2995a90a7c37 | 2024-04-15 | Warnings | M016 |
| Chapstick Moisturizer Variety Pack | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM | Haleon US Holdings LLC | bfb9a2d5-1ad2-45b8-a215-9d1370af5337 | 2024-04-12 | Warnings | M016 |
| ChapStick Classic Spearmint | PETROLATUM | Haleon US Holdings LLC | d39786e8-bcd8-479d-8990-142a21788a47 | 2024-04-12 | Warnings | M016 |
| Chapstick 12 Days of Christmas | WHITE PETROLATUM | Haleon US Holdings LLC | d6eb2ea6-27c7-40a6-a1f0-789ea2131de3 | 2024-04-11 | Warnings | M016 |
| Chapstick Active 2in1 Variety Pack | ZINC OXIDE | Haleon US Holdings LLC | d1998a9e-d61f-4b4c-91b0-5e66754bcc4a | 2024-04-11 | Warnings | M016 |
| Chapstick 12 Days of Christmas | WHITE PETROLATUM | Haleon US Holdings LLC | 040694f0-b5ba-4203-bde9-699fa9b1afef | 2024-04-11 | Warnings | M016 |
| Chapstick Holiday Classics Kit | WHITE PETROLATUM | Haleon US Holdings LLC | 6df216dc-c03d-463a-8029-5e54c1dc3d27 | 2024-04-11 | Warnings | M016 |
| Carmex Classic Lip Balm Medicated SPF15 Triple Force Formula | OCTINOXATE, OXYBENZONE, WHITE PETROLATUM | Carma Laboratories, Inc. | 3eb0f8ff-89e7-4410-8573-3349e4946548 | 2024-04-02 | Warnings | M016 |
| Pure Cornstarch Baby | CORN STARCH | Walgreen Company | d0e9bd13-b568-4f7e-b036-8d23e71ad8bf | 2024-03-25 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1654149 | colloidal oatmeal 0.5 % Topical Cream | PSN | 4e43b65c-d5bb-f228-e063-6294a90ad08d | 1 |
| 1654149 | colloidal oatmeal 5 MG/ML Topical Cream | SCD | 4e43b65c-d5bb-f228-e063-6294a90ad08d | 1 |
| 1654149 | colloidal oatmeal 0.5 % Topical Cream | SY | 4e43b65c-d5bb-f228-e063-6294a90ad08d | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 10637-1901-1 | 10637190101 | 28.3 g in 1 TUBE (10637-1901-1) | 28.3 g | 2025-11-30 | No | No | Current |