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 |
|---|---|---|---|---|---|---|
| CVS Itch Relief | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | CVS Pharmacy | c60cfbf2-6788-43dc-b23a-e3433b7f3265 | 2023-12-20 | Warnings | M016 |
| Sunmark Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Strategic Sourcing Services LLC | c7467f21-56cc-43ca-abfa-e62d35c8baa6 | 2023-12-19 | Warnings | M016 |
| Sunmark Witch Hazel | WITCH HAZEL | Strategic Sourcing Services LLC | 08c00c1a-7ec8-4624-9db0-a0e8430cd126 | 2023-12-19 | Warnings | M016 |
| Sunmark Caldyphen Clear | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Strategic Sourcing Services LLC | 329cd4ef-b699-46ff-a5d6-907f7c327c03 | 2023-12-19 | Warnings | M016 |
| DDM Calaclear | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Discount Drug Mart | 5d536077-b5c6-29b8-e053-2a91aa0a9ae1 | 2023-12-19 | Warnings | M016 |
| Sunmark Phenolated Calamine | CALAMINE AND ZINC OXIDE AND PHENOL | Strategic Sourcing Services LLC | 8e68efc4-4c95-41c0-9fed-32297b1b2edc | 2023-12-19 | Warnings | M016 |
| Calm and Heal Melting Balm | ALLANTOIN | The Honest Company, Inc. | b08a1bd6-986d-9520-e053-2995a90a865e | 2023-12-19 | Warnings | M016 |
| TopCare Calagesic | CALAMINE AND PRAMOXINE HYDROCHLORIDE LOTION | TOPCO ASSOCIATES LLC | 8dced3ea-147b-3d46-e053-2a95a90aa1c0 | 2023-12-18 | Warnings | M016 |
| TopCare Calamine | CALAMINE 8% AND ZINC OXIDE 8% LOTION | TOPCO ASSOCIATES LLC | 8dcf134e-0427-0c43-e053-2995a90a7c26 | 2023-12-18 | Warnings | M016 |
| HEB Calaclear | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | H E B | 5d576794-88d1-484a-e053-2991aa0aa479 | 2023-12-18 | Warnings | M016 |
| Publix Calamine Medicated | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Publix | 5d6ba4cf-f2cb-0ecb-e053-2991aa0a5673 | 2023-12-18 | Warnings | M016 |
| TopCare Calaclear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION | TOPCO ASSOCIATES LLC | 8dce8817-b905-4064-e053-2995a90a071e | 2023-12-18 | Warnings | M016 |
| Assured Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Greenbriar International | 9d378cc5-9af0-1389-e053-2995a90a0b96 | 2023-12-18 | Warnings | M016 |
| HEB Calagesic | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | H E B | 5d579680-6bcb-1161-e053-2991aa0aead1 | 2023-12-18 | Warnings | M016 |
| Publix Clear Anti-Itch | ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE | Publix | 5d6b905f-ed30-1ab7-e053-2a91aa0a816b | 2023-12-18 | Warnings | M016 |
| Humco Calaclear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | Humco Holding Group, Inc. | 5fca3a73-6d66-496b-bd33-6e044f9039bc | 2023-12-15 | Warnings | M016 |
| Calamine Phenolated Topical Suspension | CALAMINE AND ZINC OXIDE AND PHENOL | Humco Holding Group, Inc | a3816729-be2b-4b4f-a609-953576cd2e3b | 2023-12-15 | Warnings | M016 |
| Humco Mineral Oil Light | MINERAL OIL | Humco Holding Group, Inc. | 753f35c3-1420-4817-ba63-b737a9c99a1d | 2023-12-15 | Warnings | M016 |
| Humco Witch Hazel | WITCH HAZEL | Humco Holding Group, Inc. | 3cf07016-a129-49ca-8fad-b67dda5aa009 | 2023-12-15 | Warnings | M016 |
| Rite Aid Calamine | CALAMINE 8% AND ZINC OXIDE 8% | Rite Aid Corporation | 5df71189-9b36-9dee-e053-2a91aa0a9e49 | 2023-12-15 | 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 |