calahist

Generic: calamine and pramoxine hydrochloride

Labeler: walgreen company
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name calahist
Generic Name calamine and pramoxine hydrochloride
Labeler walgreen company
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

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

Manufacturer
WALGREEN COMPANY

Identifiers & Regulatory

Product NDC 0363-9411
Product ID 0363-9411_079d3e20-150d-ce65-e063-6294a90af07f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2023-10-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03639411
Hyphenated Format 0363-9411

Supplemental Identifiers

RxCUI
1234532
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 calahist (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 (0363-9411-97)
source: ndc

Packages (1)

0363-9411-97 177 mL in 1 BOTTLE (0363-9411-97)

Ingredients (2)

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

Linked Drug Pages (1)

calahist ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "079d3e20-150d-ce65-e063-6294a90af07f", "openfda": {"unii": ["88AYB867L5", "SOI2LOH54Z"], "rxcui": ["1234532"], "spl_set_id": ["fed45e06-cc53-fbc5-e053-6294a90a1b19"], "manufacturer_name": ["WALGREEN COMPANY"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE (0363-9411-97)", "package_ndc": "0363-9411-97", "marketing_start_date": "20231016"}], "brand_name": "calahist", "product_id": "0363-9411_079d3e20-150d-ce65-e063-6294a90af07f", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "0363-9411", "generic_name": "Calamine and Pramoxine Hydrochloride", "labeler_name": "WALGREEN COMPANY", "product_type": "HUMAN OTC DRUG", "brand_name_base": "calahist", "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": "20231016", "listing_expiration_date": "20261231"}