rugby caldyphen clear

Generic: pramoxine hydrochloride and zinc acetate lotion

Labeler: rugby laboratories
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name rugby caldyphen clear
Generic Name pramoxine hydrochloride and zinc acetate lotion
Labeler rugby laboratories
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

pramoxine hydrochloride 10 mg/mL, zinc acetate 1 mg/mL

Manufacturer
Rugby Laboratories

Identifiers & Regulatory

Product NDC 0536-1269
Product ID 0536-1269_3afc5367-562d-b4a0-e063-6294a90a2560
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Marketing Start 2019-12-30
Marketing End 2027-09-30

Pharmacologic Class

Classes
copper absorption inhibitor [epc] decreased copper ion absorption [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05361269
Hyphenated Format 0536-1269

Supplemental Identifiers

RxCUI
1234546
UNII
88AYB867L5 FM5526K07A

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 rugby caldyphen clear (source: ndc)
Generic Name pramoxine hydrochloride and zinc acetate lotion (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
  • 1 mg/mL
source: ndc
Packaging
  • 177 mL in 1 CONTAINER (0536-1269-58)
source: ndc

Packages (1)

0536-1269-58 177 mL in 1 CONTAINER (0536-1269-58)

Ingredients (2)

pramoxine hydrochloride (10 mg/mL) zinc acetate (1 mg/mL)

Linked Drug Pages (1)

Rugby Caldyphen Clear ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3afc5367-562d-b4a0-e063-6294a90a2560", "openfda": {"unii": ["88AYB867L5", "FM5526K07A"], "rxcui": ["1234546"], "spl_set_id": ["9af3a740-ef97-26ce-e053-2a95a90a0ee1"], "manufacturer_name": ["Rugby Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 CONTAINER (0536-1269-58)", "package_ndc": "0536-1269-58", "marketing_end_date": "20270930", "marketing_start_date": "20191230"}], "brand_name": "Rugby Caldyphen Clear", "product_id": "0536-1269_3afc5367-562d-b4a0-e063-6294a90a2560", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "0536-1269", "generic_name": "pramoxine hydrochloride and zinc acetate lotion", "labeler_name": "Rugby Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Rugby Caldyphen Clear", "active_ingredients": [{"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/mL"}, {"name": "ZINC ACETATE", "strength": "1 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20270930", "marketing_start_date": "20191230"}