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 |
|---|---|---|---|---|---|---|
| Diaper Rash | ZINC OXIDE | Target Corporation | 8059f489-f144-4de5-9454-ac6c1af35dd2 | 2026-02-18 | Warnings, Adverse reactions | M016 |
| Coconut Milk and Shea Petroleum Jelly | WHITE PETROLATUM | Target Corporation | c78d9864-92e0-4ad8-8a9b-9752ac6784e8 | 2026-02-18 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Strategic Sourcing Services LLC | 043375b2-e636-4822-9e05-df2327d29986 | 2026-02-17 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Strategic Sourcing Services LLC | 3ade1f7f-a870-4f77-96b9-f63bf4cdf5ae | 2026-02-17 | Warnings, Adverse reactions | M016 |
| Pure petroleum | WHITE PETROLATUM | Valu Merchandisers Company | 4113bb6e-070a-4116-a8d6-12c6b4475beb | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | Valu Merchandisers Company | e5465ddd-e38c-44a4-bb9b-3edbc636576d | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Valu Merchandisers Company | 8b8decec-e921-4ff9-bb49-7e38e34724f6 | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Daily Moisturizing | DIMETHICONE | Valu Merchandisers Company | 0cccadd7-11f3-5d1f-e063-6294a90a55c4 | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Witch Hazel | WITCH HAZEL | Valu Merchandisers Company | 7c6fa37f-79b8-4409-b7a9-3f02332f887a | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | United Natural Foods, Inc. dba UNFI | 014d0028-486e-4f1c-a14f-8162e393ebca | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | United Natural Foods, Inc. dba UNFI | 29a3a719-5e8b-407d-b9d9-bdba26758292 | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | Topco Associates LLC | 8acb1b47-70ed-4aa2-a7c0-e807042affc7 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Calamine | FERRIC OXIDE RED | Topco Associates LLC | 2b32e720-ac71-4d60-bc06-e28a00f8a450 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Pure petroleum | WHITE PETROLATUM | Topco Associates LLC | 3babe2cf-9e6c-4f22-940f-c1fdf489f1c7 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Clear Anti Itch | PRAMOXINE HCL, ZINC ACETATE | Topco Associates LLC | 8d3d1ff5-4868-495d-807c-e45aa2176f63 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Healing | PETROLATUM | Topco Associates LLC | b929b159-4af5-4a03-8e7c-676a6ba2bf55 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE, PRAMOXINE HCL | Topco Associates LLC | 15d1ae3f-509c-4e6b-8f0c-cf9265680358 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Topco Associates LLC | cd7f1727-0b6e-4993-9820-43783994efa1 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Dimethicone | DIMETHICONE | Topco Associates LLC | f37f17f7-f084-4b74-8361-178d2315a476 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Baby Eczema Therapy | COLLOIDAL OATMEAL | Topco Associates LLC | 4f6af42c-f41e-455f-b94b-3793bf0b9a3f | 2026-02-13 | 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 |