calamine plus pramoxine hcl

Generic: calamine plus spray

Labeler: fsa store 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 spray
Labeler fsa store 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
FSA Store Inc.

Identifiers & Regulatory

Product NDC 81522-959
Product ID 81522-959_3cd1933c-6340-50d6-e063-6294a90aca32
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2025-08-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81522959
Hyphenated Format 81522-959

Supplemental Identifiers

RxCUI
1544717
UPC
0810025928988
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
  • 5 mg/g
  • 10 mg/g
  • 75 mg/g
source: ndc
Packaging
  • 116 g in 1 CAN (81522-959-01)
source: ndc

Packages (1)

81522-959-01 116 g in 1 CAN (81522-959-01)

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": "3cd1933c-6340-50d6-e063-6294a90aca32", "openfda": {"upc": ["0810025928988"], "unii": ["1K09F3G675", "88AYB867L5", "SOI2LOH54Z"], "rxcui": ["1544717"], "spl_set_id": ["3cd18f96-34f7-3f2c-e063-6294a90a3b7e"], "manufacturer_name": ["FSA Store Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "116 g in 1 CAN (81522-959-01)", "package_ndc": "81522-959-01", "marketing_start_date": "20250812"}], "brand_name": "Calamine Plus Pramoxine HCl", "product_id": "81522-959_3cd1933c-6340-50d6-e063-6294a90aca32", "dosage_form": "AEROSOL, SPRAY", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "81522-959", "generic_name": "Calamine Plus Spray", "labeler_name": "FSA Store 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": "20250812", "listing_expiration_date": "20261231"}