First Aid Beauty FAB Ultra Repair Skin Protectant Winter Mint
- Product NDC
- 84126-044
- 11-digit product format
- 841260044
- Labeler code
- 84126
- Product ID
- 84126-044_46429cd9-bfee-523a-e063-6394a90a5080
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Colloidal Oatmeal
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- The Procter & Gamble Manufacturing Company
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-10-01
- 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
- 2026-12-31
- 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 Skin Protectant Winter Mint
- Listing expiration
- 2026-12-31
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 |
|---|---|
| 275ece2b-deb9-c95b-e063-6394a90aa939 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84126-044-56 | First Aid Beauty FAB Ultra Repair Skin Protectant Winter Mint | 56.7 g in 1 TUBE | CREAM | 56.7 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 84126-044 | FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT WINTER MINT (COLLOIDAL OATMEAL) CREAM [THE PROCTER & GAMBLE MANUFACTURING COMPANY] | 1 | Current NDC, 1 package rows | 20241122_275ece2b-deb9-c95b-e063-6394a90aa939.zip |
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 |
|---|---|---|---|---|---|---|
| DawnMist White Petrolatum | WHITE PETROLATUM | Dukal LLC | 598e9d46-6450-af60-e063-6394a90a3a6b | 2026-08-21 | Warnings | M016 |
| MUSTELA Diaper Rash 1 2 3 | ZINC OXIDE | Expanscience Laboratories d/b/a Mustela | 163f388e-849d-4b7e-93c1-9045d77a9ec2 | 2026-08-21 | Warnings | M016 |
| Medline | WHITE PETROLATUM, ZINC OXIDE | Medline Industries, LP | 0073de92-585d-e01a-e063-6394a90a2ec2 | 2026-08-21 | Warnings | M016 |
| Mederma PM | DIMETHICONE | L Perrigo Company | 8c728904-28f4-4333-a9ea-20996fd1b007 | 2026-08-21 | Warnings | M016 |
| Earths Care Hemorrhoid Relief | WITCH HAZEL AND MENTHOL, UNSPECIFIED FORM | DLC Laboratories, Inc. | e860d65b-126d-4d77-8003-9d1381849ab5 | 2026-08-20 | Warnings | M016 |
| ClaraVie | PETROLATUM | Gentell LLC | 596987e4-4205-b911-e063-6294a90aa570 | 2026-08-19 | Warnings | M016 |
| ClaraVie | ZINC OXIDE | Gentell LLC | 596abd98-17d7-2a22-e063-6294a90af57d | 2026-08-19 | Warnings | M016 |
| Claravie Skin Repair Cream | DIMETHICONE | Gentell LLC | 596ae269-172e-aef5-e063-6394a90a4e2a | 2026-08-19 | Warnings | M016 |
| Claravie | LANOLIN | Gentell LLC | 596c1b73-e34d-c97d-e063-6394a90ada1b | 2026-08-19 | Warnings | M016 |
| ClaraVie | MENTHOL, ZINC OXIDE | Gentell LLC | 596c467f-a056-ea78-e063-6394a90a79f2 | 2026-08-19 | Warnings | M016 |
| ClaraVie | LANOLIN | Gentell LLC | 596fe32d-be34-0635-e063-6394a90a2fc0 | 2026-08-19 | Warnings | M016 |
| Medpride | ZINC OXIDE | Shield Line LLC | e2689cae-e347-4c0b-825b-6281a0b7c2f1 | 2026-08-18 | Warnings | M016 |
| Eczema Skin Relief Cream | COLLOIDAL OATMEAL | CVS Health | 98fac854-f7b0-4c6e-888d-1bdc6b9323b9 | 2026-08-17 | Warnings | M016 |
| Zinc Oxide | ZINC OXIDE | ADUSA Distribution, LLC | 5940399c-31e3-6d51-e063-6294a90a8e7c | 2026-08-17 | Warnings, Adverse reactions | M016 |
| Intimate CareGel | HYALURONIC ACID | Guangzhou Yilong Cosmetics.,Ltd | 5918d204-52db-e6d0-e063-6394a90ab78c | 2026-08-14 | Warnings | M016 |
| TENA Proskin protective cream | ZINC OXIDE | Essity HMS North America Inc. | b840377f-a297-4aff-900e-7ea8b7c98717 | 2026-08-13 | Warnings, Adverse reactions | M016 |
| Medline | WHITE PETROLATUM, ZINC OXIDE | Medline Industries, LP | 087d66ff-1a8c-dcb2-e063-6294a90a2f8c | 2026-08-11 | Warnings | M016 |
| Nail Renewal Liquid | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 581f7192-fc17-a706-e063-6394a90a3ffa | 2026-08-11 | Warnings | M016 |
| Intertrigo Relief Cream | GLYCERIN | Shantou South Moon Biotechnology Co., Ltd. | 587220c9-0ae9-3438-e063-6394a90a0a86 | 2026-08-07 | Warnings | M016 |
| Calamine | FERRIC OXIDE RED | The Kroger Co. | 9ddcd6ba-1aed-48f8-a91a-54bd6f0d9308 | 2026-08-06 | Warnings, Adverse reactions | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1654149 | colloidal oatmeal 0.5 % Topical Cream | PSN | 275ece2b-deb9-c95b-e063-6394a90aa939 | 2 |
| 1654149 | colloidal oatmeal 5 MG/ML Topical Cream | SCD | 275ece2b-deb9-c95b-e063-6394a90aa939 | 2 |
| 1654149 | colloidal oatmeal 0.5 % Topical Cream | SY | 275ece2b-deb9-c95b-e063-6394a90aa939 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 84126-044-56 | 84126004456 | 56.7 g in 1 TUBE (84126-044-56) | 56.7 g | 2024-10-01 | No | No | Current |