calamine plus pramoxine hcl

Generic: calamine plus no touch spray

Labeler: premier brands of america inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name calamine plus pramoxine hcl
Generic Name calamine plus no touch spray
Labeler premier brands of america inc.
Dosage Form AEROSOL, SPRAY
Routes
TOPICAL
Active Ingredients

ferric oxide red 5 mg/g, pramoxine hydrochloride 10 mg/g, zinc oxide 75 mg/g

Manufacturer
Premier Brands of America Inc.

Identifiers & Regulatory

Product NDC 56104-100
Product ID 56104-100_42b813fe-1a86-a199-e063-6394a90a1eff
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2025-05-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 56104100
Hyphenated Format 56104-100

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 no touch spray (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/g
  • 10 mg/g
  • 75 mg/g
source: ndc
Packaging
  • 116 g in 1 CAN (56104-100-10)
source: ndc

Packages (1)

56104-100-10 116 g in 1 CAN (56104-100-10)

Ingredients (3)

ferric oxide red (5 mg/g) pramoxine hydrochloride (10 mg/g) zinc oxide (75 mg/g)

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": "42b813fe-1a86-a199-e063-6394a90a1eff", "openfda": {"unii": ["1K09F3G675", "88AYB867L5", "SOI2LOH54Z"], "rxcui": ["1544717"], "spl_set_id": ["36481d67-2346-470b-e063-6294a90aae99"], "manufacturer_name": ["Premier Brands of America Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "116 g in 1 CAN (56104-100-10)", "package_ndc": "56104-100-10", "marketing_start_date": "20250528"}], "brand_name": "Calamine Plus Pramoxine HCl", "product_id": "56104-100_42b813fe-1a86-a199-e063-6394a90a1eff", "dosage_form": "AEROSOL, SPRAY", "product_ndc": "56104-100", "generic_name": "Calamine Plus No Touch Spray", "labeler_name": "Premier Brands of America Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Calamine Plus Pramoxine HCl", "active_ingredients": [{"name": "FERRIC OXIDE RED", "strength": "5 mg/g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/g"}, {"name": "ZINC OXIDE", "strength": "75 mg/g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250528", "listing_expiration_date": "20261231"}