Pramoxine Hydrochloride Anorectal
- Product NDC
- 58980-522
- 11-digit product format
- 589800522
- Labeler code
- 58980
- Product ID
- 58980-522_a3ed95de-1df1-46d0-bc60-938274ffbc7d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pramoxine Hydrochloride
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Stratus Pharmaceuticals
- Application
- M015
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-11-01
- Substance
- PRAMOXINE HYDROCHLORIDE
- Active strength
- 1 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pramoxine Hydrochloride Anorectal
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PRAMOXINE HYDROCHLORIDE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 88AYB867L5 |
| Rxcui | 1246075 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58980-522-40 | Pramoxine Hydrochloride Anorectal | 118 mL in 1 BOTTLE | LOTION | 118 | | 1 |
| 58980-522-40 | Pramoxine Hydrochloride Anorectal | 1 in 1 BOX | LOTION | 1 | | 1 |
| 58980-522-80 | Pramoxine Hydrochloride Anorectal | 1 in 1 BOX | LOTION | 1 | | 1 |
| 58980-522-80 | Pramoxine Hydrochloride Anorectal | 237 mL in 1 BOTTLE | LOTION | 237 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58980-522-40 | 58980052240 | 1 BOTTLE in 1 BOX (58980-522-40) / 118 mL in 1 BOTTLE | 1 bottle | 2025-11-01 | No | No | Current |
| 58980-522-80 | 58980052280 | 1 BOTTLE in 1 BOX (58980-522-80) / 237 mL in 1 BOTTLE | 1 bottle | 2025-11-01 | No | No | Current |