calamine

Generic: calamine

Labeler: amerisource bergen
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name calamine
Generic Name calamine
Labeler amerisource bergen
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

ferric oxide red 80 mg/100mL, zinc oxide 80 mg/100mL

Manufacturer
AMERISOURCE BERGEN

Identifiers & Regulatory

Product NDC 46122-809
Product ID 46122-809_498db13a-f81f-8a0a-e063-6294a90a814c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2027-12-31
Marketing Start 2025-04-23

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46122809
Hyphenated Format 46122-809

Supplemental Identifiers

RxCUI
617954
UNII
1K09F3G675 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 (source: ndc)
Generic Name calamine (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/100mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE, PLASTIC (46122-809-29)
source: ndc

Packages (1)

46122-809-29 177 mL in 1 BOTTLE, PLASTIC (46122-809-29)

Ingredients (2)

ferric oxide red (80 mg/100mL) zinc oxide (80 mg/100mL)

Linked Drug Pages (1)

Calamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "498db13a-f81f-8a0a-e063-6294a90a814c", "openfda": {"unii": ["1K09F3G675", "SOI2LOH54Z"], "rxcui": ["617954"], "spl_set_id": ["90d9d908-57ea-4062-ade0-8a4888939c91"], "manufacturer_name": ["AMERISOURCE BERGEN"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (46122-809-29)", "package_ndc": "46122-809-29", "marketing_start_date": "20250423"}], "brand_name": "Calamine", "product_id": "46122-809_498db13a-f81f-8a0a-e063-6294a90a814c", "dosage_form": "LOTION", "product_ndc": "46122-809", "generic_name": "Calamine", "labeler_name": "AMERISOURCE BERGEN", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Calamine", "active_ingredients": [{"name": "FERRIC OXIDE RED", "strength": "80 mg/100mL"}, {"name": "ZINC OXIDE", "strength": "80 mg/100mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250423", "listing_expiration_date": "20271231"}