Triple 3x Max Diaper Rash
- Product NDC
- 16864-061
- 11-digit product format
- 168640061
- Labeler code
- 16864
- Product ID
- 16864-061_51d0a7c7-f1fa-2e15-e063-6394a90a678b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ZINC OXIDE
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Advantice Health, LLC
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-05-15
- Substance
- ZINC OXIDE
- Active strength
- 40 g/100g
- 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
- Triple 3x Max Diaper Rash
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 40 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e554046b-cd0a-4a6e-8f24-2e610c697432 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 16864-061-01 | Triple 3x Max Diaper Rash | 1 in 1 CARTON | OINTMENT | 1 | 5 | |
| 16864-061-01 | Triple 3x Max Diaper Rash | 57 g in 1 TUBE | OINTMENT | 57 | 5 | |
| 16864-061-02 | Triple 3x Max Diaper Rash | 170 g in 1 TUBE | OINTMENT | 170 | 5 | |
| 16864-061-03 | Triple 3x Max Diaper Rash | 284 g in 1 JAR | OINTMENT | 284 | 5 | |
| 16864-061-04 | Triple 3x Max Diaper Rash | 340 g in 1 JAR | OINTMENT | 340 | 5 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| First Aid Beauty FAB Ultra Repair Body Skin Protectant | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 1a9d86fc-ef32-baed-e063-6394a90a7d74 | 2026-03-12 | Warnings | M016 |
| Meijer Scar Gel | ALLANTOIN 0.5% | Meijer | 4c108c34-72f3-1382-e063-6394a90a7f2c | 2026-03-11 | Warnings | M016 |
| E2 hand wash | E2 SANITIZING HAND SOAP | Horizon Tool Inc. | a40afa46-a07d-f864-e053-2a95a90aef8a | 2026-03-11 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Skin Protectant Sugar Cookie | COLLOIDAL OATMEAL | The Procter & Gamble Manufacturing Company | 4576cd28-9530-4db4-e063-6394a90a9fd3 | 2026-03-10 | Warnings | M016 |
| Diaper Rash | ZINC OXIDE | Lidl US, LLC | e399b33f-5f7c-47eb-8e9b-1721ae4680b5 | 2026-03-10 | Warnings, Adverse reactions | M016 |
| Vitamin A D | WHITE PETROLATUM | Sion Biotext Medical Ltd. | 503c4ab9-1f60-48e2-af47-7ef996466a5b | 2026-03-09 | Warnings | M016 |
| Trstay | RETINOL SERUM | Shenzhen yuehaotong Technology Co.,Ltd | 4c6e20dd-0a71-a96b-e063-6294a90ab833 | 2026-03-07 | Warnings | M016 |
| 2-Pack Facial Serum | 2-PACK FACIAL SERUM | Guangzhou Ariel Biotech Co., Ltd. | 27c7f645-cfb3-6db1-e063-6394a90a42ff | 2026-03-06 | Warnings | M016 |
| 2-Pack Facial Serum | 2-PACK FACIAL SERUM | Guangzhou Ariel Biotech Co., Ltd. | 27c89fc6-016b-d359-e063-6394a90a5602 | 2026-03-06 | Warnings | M016 |
| Boudreauxs | ZINC OXIDE | C.B. Fleet Company, Inc. | f8f626c8-13ae-4b3b-ae3f-e0dc800fcb4a | 2026-03-06 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin Protectant | DIMETHICONE | The Procter & Gamble Manufacturing Company | 276c68d4-e273-4e48-e063-6294a90ab16f | 2026-03-04 | Warnings | M016 |
| Nicotine Patches | NICOTINE PATCHES | Zhejiang FTA Shengzuozhi Biotechnology Co., LTD | 4c1d00b3-313b-933f-e063-6294a90ac46f | 2026-03-03 | Warnings | M016 |
| Zinc Oxide | ZINC OXIDE | Amazon.com Services LLC | 495fffd7-7b64-954a-e063-6394a90a81fd | 2026-03-03 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE, PRAMOXINE HCL | Amazon.com Services LLC | aceb0b10-8c90-4a06-8c47-cd1a2b4676a3 | 2026-03-03 | Warnings, Adverse reactions | M016 |
| Witch Hazel | WITCH HAZEL | Amazon.com Services LLC | 134e07a1-5236-4088-baf9-1ff33126f793 | 2026-03-03 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | Old East Main Co. | 7f56ab98-dbd8-412a-8c31-bb6302b7f329 | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Calamine | FERRIC OXIDE RED | Old East Main Co. | c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Pure petroleum | WHITE PETROLATUM | Old East Main Co. | ae8583c0-1b52-461d-8506-ec7524f1b4c4 | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Healing for Babies | PETROLATUM | Old East Main Co. | aa1acc24-56af-4708-bf76-23d4de3d089e | 2026-03-02 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Old East Main Co. | de8d8071-ecb2-4719-8c7b-7944f27810d6 | 2026-03-02 | Warnings, Adverse reactions | M016 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 16864-061-01 | 16864006101 | 1 TUBE in 1 CARTON (16864-061-01) / 57 g in 1 TUBE | 1 tube | 2024-05-15 | No | No | Current |
| 16864-061-02 | 16864006102 | 170 g in 1 TUBE (16864-061-02) | 170 g | 2024-10-15 | No | No | Current |
| 16864-061-03 | 16864006103 | 284 g in 1 JAR (16864-061-03) | 284 g | 2025-12-01 | No | No | Current |
| 16864-061-04 | 16864006104 | 340 g in 1 JAR (16864-061-04) | 340 g | 2024-05-15 | No | No | Current |