pramoxine hydrochloride anorectal

Generic: pramoxine hydrochloride

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

Drug Facts

Product Profile

Brand Name pramoxine hydrochloride anorectal
Generic Name pramoxine hydrochloride
Labeler stratus pharmaceuticals
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

pramoxine hydrochloride 1 mg/mL

Manufacturer
Stratus Pharmaceuticals

Identifiers & Regulatory

Product NDC 58980-522
Product ID 58980-522_a3ed95de-1df1-46d0-bc60-938274ffbc7d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2025-11-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58980522
Hyphenated Format 58980-522

Supplemental Identifiers

RxCUI
1246075
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 pramoxine hydrochloride anorectal (source: ndc)
Generic Name pramoxine hydrochloride (source: ndc)
Application Number M015 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (58980-522-40) / 118 mL in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (58980-522-80) / 237 mL in 1 BOTTLE
source: ndc

Packages (2)

58980-522-40 1 BOTTLE in 1 BOX (58980-522-40) / 118 mL in 1 BOTTLE 58980-522-80 1 BOTTLE in 1 BOX (58980-522-80) / 237 mL in 1 BOTTLE

Ingredients (1)

pramoxine hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Pramoxine Hydrochloride Anorectal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "a3ed95de-1df1-46d0-bc60-938274ffbc7d", "openfda": {"unii": ["88AYB867L5"], "rxcui": ["1246075"], "spl_set_id": ["39a16b66-b0e9-412f-8773-8dec0a1227e0"], "manufacturer_name": ["Stratus Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (58980-522-40)  / 118 mL in 1 BOTTLE", "package_ndc": "58980-522-40", "marketing_start_date": "20251101"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (58980-522-80)  / 237 mL in 1 BOTTLE", "package_ndc": "58980-522-80", "marketing_start_date": "20251101"}], "brand_name": "Pramoxine Hydrochloride Anorectal", "product_id": "58980-522_a3ed95de-1df1-46d0-bc60-938274ffbc7d", "dosage_form": "LOTION", "product_ndc": "58980-522", "generic_name": "Pramoxine Hydrochloride", "labeler_name": "Stratus Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pramoxine Hydrochloride Anorectal", "active_ingredients": [{"name": "PRAMOXINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251101", "listing_expiration_date": "20261231"}