Pramoxine hydrochloride
- Product NDC
- 51862-180
- 11-digit product format
- 518620180
- Labeler code
- 51862
- Product ID
- 51862-180_920da7e2-796f-41c2-a6dc-f01a90537d90
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pramoxine hydrochloride
- Dosage form
- AEROSOL, FOAM
- Route
- TOPICAL
- Labeler
- Mayne Pharma
- Application
- part346
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2011-10-31
- Marketing end
- 0000-00-00
- Substance
- PRAMOXINE HYDROCHLORIDE
- Active strength
- 10 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 | 51862-180 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 51862-180 | 51862-180-15 | D | Discontinued by firm | | 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
WARNINGS For external use only. When using this product, avoid contact with eyes.
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PRAMOXINE HYDROCHLORIDE | ACTIVE INGREDIENT | 88AYB867L5 | PRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [LIBERTAS PHARMA, INC.] | 1 | |
| PRAMOXINE | ACTIVE MOIETY | 068X84E056 | PRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [LIBERTAS PHARMA, INC.] | 1 | |
| CETETH-20 | INACTIVE INGREDIENT | I835H2IHHX | PRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [LIBERTAS PHARMA, INC.] | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | PRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [LIBERTAS PHARMA, INC.] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | PRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [LIBERTAS PHARMA, INC.] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | PRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [LIBERTAS PHARMA, INC.] | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | PRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [LIBERTAS PHARMA, INC.] | 1 | |
| SORBITAN TRIOLEATE | INACTIVE INGREDIENT | QE6F49RPJ1 | PRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [LIBERTAS PHARMA, INC.] | 1 | |
| TETRAFLUOROMETHANE | INACTIVE INGREDIENT | 94WG9QG0JN | PRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [LIBERTAS PHARMA, INC.] | 1 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | PRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [LIBERTAS PHARMA, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | PRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [LIBERTAS PHARMA, INC.] | 1 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | PRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [LIBERTAS PHARMA, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51862-180 | PRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [MAYNE PHARMA] | 3 | Legacy NDC | 20171216_54a5e0e3-a400-4cc8-87eb-bcab8309786d.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51862-180-15 | 51862018015 | 1 CONTAINER in 1 CARTON (51862-180-15) > 15 g in 1 CONTAINER | 1 container | 2011-10-31 | 0000-00-00 | No | No | Current |