peviderm pramoxine hydrocholride 1%

Generic: pramoxine hydrochloride

Labeler: stratus pharmaceuticals inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name peviderm pramoxine hydrocholride 1%
Generic Name pramoxine hydrochloride
Labeler stratus pharmaceuticals inc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

pramoxine hydrochloride 1 mg/mL

Manufacturer
Stratus Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 58980-913
Product ID 58980-913_119ef16e-c873-41df-9e98-4ccade286a85
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2024-11-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58980913
Hyphenated Format 58980-913

Supplemental Identifiers

UNII
88AYB867L5

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name peviderm pramoxine hydrocholride 1% (source: ndc)
Generic Name pramoxine hydrochloride (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (58980-913-80) / 222 mL in 1 BOTTLE
source: ndc

Packages (1)

58980-913-80 1 BOTTLE in 1 BOX (58980-913-80) / 222 mL in 1 BOTTLE

Ingredients (1)

pramoxine hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Peviderm Pramoxine Hydrocholride 1% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "119ef16e-c873-41df-9e98-4ccade286a85", "openfda": {"unii": ["88AYB867L5"], "spl_set_id": ["680b40fa-1922-443a-a4b0-7c3f6a2b847d"], "manufacturer_name": ["Stratus Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (58980-913-80)  / 222 mL in 1 BOTTLE", "package_ndc": "58980-913-80", "marketing_start_date": "20241101"}], "brand_name": "Peviderm Pramoxine Hydrocholride 1%", "product_id": "58980-913_119ef16e-c873-41df-9e98-4ccade286a85", "dosage_form": "LOTION", "product_ndc": "58980-913", "generic_name": "Pramoxine Hydrochloride", "labeler_name": "Stratus Pharmaceuticals Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Peviderm Pramoxine Hydrocholride 1%", "active_ingredients": [{"name": "PRAMOXINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241101", "listing_expiration_date": "20261231"}