calamine

Generic: calamine, pramoxine hcl

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

Drug Facts

Product Profile

Brand Name calamine
Generic Name calamine, pramoxine hcl
Labeler topco associates llc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

ferric oxide red 80 mg/mL, pramoxine hydrochloride 10 mg/mL

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 76162-336
Product ID 76162-336_4ab90806-7257-8b97-e063-6294a90a71c3
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2027-12-31
Marketing Start 2009-05-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76162336
Hyphenated Format 76162-336

Supplemental Identifiers

RxCUI
1234532
UNII
1K09F3G675 88AYB867L5

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 (source: ndc)
Generic Name calamine, pramoxine hcl (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/mL
  • 10 mg/mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE, PLASTIC (76162-336-30)
source: ndc

Packages (1)

76162-336-30 177 mL in 1 BOTTLE, PLASTIC (76162-336-30)

Ingredients (2)

ferric oxide red (80 mg/mL) pramoxine hydrochloride (10 mg/mL)

Linked Drug Pages (1)

Calamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4ab90806-7257-8b97-e063-6294a90a71c3", "openfda": {"unii": ["1K09F3G675", "88AYB867L5"], "rxcui": ["1234532"], "spl_set_id": ["15d1ae3f-509c-4e6b-8f0c-cf9265680358"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (76162-336-30)", "package_ndc": "76162-336-30", "marketing_start_date": "20090521"}], "brand_name": "Calamine", "product_id": "76162-336_4ab90806-7257-8b97-e063-6294a90a71c3", "dosage_form": "LOTION", "product_ndc": "76162-336", "generic_name": "Calamine, Pramoxine HCl", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Calamine", "active_ingredients": [{"name": "FERRIC OXIDE RED", "strength": "80 mg/mL"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20090521", "listing_expiration_date": "20271231"}