calamine plus pramoxine hcl

Generic: calamine plus spray

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name calamine plus pramoxine hcl
Generic Name calamine plus spray
Labeler topco associates llc
Dosage Form AEROSOL, SPRAY
Routes
TOPICAL
Active Ingredients

ferric oxide red .345 mg/116g, pramoxine hydrochloride 2.72 mg/116g, zinc oxide 24.16 mg/116g

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-398
Product ID 36800-398_42f4abc5-8308-e7ed-e063-6394a90a748d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2017-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800398
Hyphenated Format 36800-398

Supplemental Identifiers

RxCUI
1544717
UNII
1K09F3G675 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 calamine plus pramoxine hcl (source: ndc)
Generic Name calamine plus spray (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .345 mg/116g
  • 2.72 mg/116g
  • 24.16 mg/116g
source: ndc
Packaging
  • 116 g in 1 CANISTER (36800-398-41)
source: ndc

Packages (1)

36800-398-41 116 g in 1 CANISTER (36800-398-41)

Ingredients (3)

ferric oxide red (.345 mg/116g) pramoxine hydrochloride (2.72 mg/116g) zinc oxide (24.16 mg/116g)

Linked Drug Pages (1)

Calamine Plus Pramoxine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "42f4abc5-8308-e7ed-e063-6394a90a748d", "openfda": {"unii": ["1K09F3G675", "88AYB867L5", "SOI2LOH54Z"], "rxcui": ["1544717"], "spl_set_id": ["af314adb-bd65-4233-b7e1-6cfb819615a3"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "116 g in 1 CANISTER (36800-398-41)", "package_ndc": "36800-398-41", "marketing_start_date": "20170101"}], "brand_name": "Calamine Plus Pramoxine HCl", "product_id": "36800-398_42f4abc5-8308-e7ed-e063-6394a90a748d", "dosage_form": "AEROSOL, SPRAY", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "36800-398", "generic_name": "Calamine Plus Spray", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Calamine Plus Pramoxine HCl", "active_ingredients": [{"name": "FERRIC OXIDE RED", "strength": ".345 mg/116g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "2.72 mg/116g"}, {"name": "ZINC OXIDE", "strength": "24.16 mg/116g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20170101", "listing_expiration_date": "20261231"}