humco calagesic

Generic: calamine and pramoxine hydrochloride

Labeler: humco holding group, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name humco calagesic
Generic Name calamine and pramoxine hydrochloride
Labeler humco holding group, inc.
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

pramoxine hydrochloride 10 mg/mL, zinc oxide 80 mg/mL

Manufacturer
Humco Holding Group, Inc.

Identifiers & Regulatory

Product NDC 0395-0420
Product ID 0395-0420_101d12b5-fd3a-678d-e063-6294a90a64ea
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 1998-03-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03950420
Hyphenated Format 0395-0420

Supplemental Identifiers

RxCUI
1234532 1234539
UNII
88AYB867L5 SOI2LOH54Z

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 humco calagesic (source: ndc)
Generic Name calamine and pramoxine hydrochloride (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
  • 80 mg/mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE, PLASTIC (0395-0420-96)
source: ndc

Packages (1)

0395-0420-96 177 mL in 1 BOTTLE, PLASTIC (0395-0420-96)

Ingredients (2)

pramoxine hydrochloride (10 mg/mL) zinc oxide (80 mg/mL)

Linked Drug Pages (1)

Humco Calagesic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "101d12b5-fd3a-678d-e063-6294a90a64ea", "openfda": {"unii": ["88AYB867L5", "SOI2LOH54Z"], "rxcui": ["1234532", "1234539"], "spl_set_id": ["8c43590d-56ec-4588-8076-99ba94a16685"], "manufacturer_name": ["Humco Holding Group, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (0395-0420-96)", "package_ndc": "0395-0420-96", "marketing_start_date": "20171113"}], "brand_name": "Humco Calagesic", "product_id": "0395-0420_101d12b5-fd3a-678d-e063-6294a90a64ea", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "0395-0420", "generic_name": "Calamine and Pramoxine Hydrochloride", "labeler_name": "Humco Holding Group, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Humco Calagesic", "active_ingredients": [{"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/mL"}, {"name": "ZINC OXIDE", "strength": "80 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19980325", "listing_expiration_date": "20261231"}