caladryl

Generic: ferric oxide red, zinc oxide, and pramoxine hydrochloride

Labeler: bausch health us, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name caladryl
Generic Name ferric oxide red, zinc oxide, and pramoxine hydrochloride
Labeler bausch health us, llc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

ferric oxide red 1.36 mg/mL, pramoxine hydrochloride 10 mg/mL, zinc oxide 78.65 mg/mL

Manufacturer
Bausch Health US, LLC

Identifiers & Regulatory

Product NDC 0187-5465
Product ID 0187-5465_24add3ce-a1f0-0b6a-e063-6394a90a77c2
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M014
Listing Expiration 2026-12-31
Marketing Start 2013-08-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01875465
Hyphenated Format 0187-5465

Supplemental Identifiers

RxCUI
1234532 1234533
UPC
0301875465063
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 caladryl (source: ndc)
Generic Name ferric oxide red, zinc oxide, and pramoxine hydrochloride (source: ndc)
Application Number M014 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1.36 mg/mL
  • 10 mg/mL
  • 78.65 mg/mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE, PLASTIC (0187-5465-06)
source: ndc

Packages (1)

0187-5465-06 177 mL in 1 BOTTLE, PLASTIC (0187-5465-06)

Ingredients (3)

ferric oxide red (1.36 mg/mL) pramoxine hydrochloride (10 mg/mL) zinc oxide (78.65 mg/mL)

Linked Drug Pages (1)

Caladryl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "24add3ce-a1f0-0b6a-e063-6394a90a77c2", "openfda": {"upc": ["0301875465063"], "unii": ["1K09F3G675", "88AYB867L5", "SOI2LOH54Z"], "rxcui": ["1234532", "1234533"], "spl_set_id": ["67d4fd42-9fed-4238-9f5a-c9403abbcf20"], "manufacturer_name": ["Bausch Health US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (0187-5465-06)", "package_ndc": "0187-5465-06", "marketing_start_date": "20130816"}], "brand_name": "Caladryl", "product_id": "0187-5465_24add3ce-a1f0-0b6a-e063-6394a90a77c2", "dosage_form": "LOTION", "product_ndc": "0187-5465", "generic_name": "Ferric Oxide Red, Zinc Oxide, and Pramoxine Hydrochloride", "labeler_name": "Bausch Health US, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Caladryl", "active_ingredients": [{"name": "FERRIC OXIDE RED", "strength": "1.36 mg/mL"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/mL"}, {"name": "ZINC OXIDE", "strength": "78.65 mg/mL"}], "application_number": "M014", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20130816", "listing_expiration_date": "20261231"}