NewTralize Gel
- Product NDC
- 75519-002
- 11-digit product format
- 755190002
- Labeler code
- 75519
- Product ID
- 75519-002_4aba66f2-b4d9-4aba-8d61-e38c995d2557
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Alcohol
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Newpark Industrial Blending Solutions LLC
- Application
- part333A
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2020-07-01
- Marketing end
- 0000-00-00
- Substance
- ALCOHOL
- Active strength
- 70 L/100L
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 75519-002 | | I | Inactivated by FDA | | 2026-07-31 |
| excluded package | package | 75519-002 | 75519-002-01 | I | Inactivated by FDA | | 2026-07-31 |
| excluded package | package | 75519-002 | 75519-002-02 | I | Inactivated by FDA | | 2026-07-31 |
| excluded package | package | 75519-002 | 75519-002-03 | I | Inactivated by FDA | | 2026-07-31 |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
For external use only. Flammable. Keep away from children.
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75519-002-01 | NewTralize Gel | 1211 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK | GEL | 1211 | | 3 |
| 75519-002-02 | NewTralize Gel | 1003 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK | GEL | 1003 | | 3 |
| 75519-002-03 | NewTralize Gel | 3.79 L in 1 BOTTLE, PLASTIC | GEL | 3.79 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75519-002 | NEWTRALIZE GEL (ALCOHOL) GEL [NEWPARK INDUSTRIAL BLENDING SOLUTIONS LLC] | 3 | Legacy NDC, 3 package rows | 20211120_60f14dc2-3f4c-4d9f-a0e0-46c644064a4b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 75519-002-01 | 75519000201 | 1211 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (75519-002-01) | 1211 l | 2020-07-01 | 0000-00-00 | No | No | Current |
| 75519-002-02 | 75519000202 | 1003 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (75519-002-02) | 1003 l | 2020-07-01 | 0000-00-00 | No | No | Current |
| 75519-002-03 | 75519000203 | 3.79 L in 1 BOTTLE, PLASTIC (75519-002-03) | 3.79 l | 2020-07-01 | 0000-00-00 | No | No | Current |