sarna

Generic: pramoxine hydrochloride, menthol

Labeler: crown laboratories, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sarna
Generic Name pramoxine hydrochloride, menthol
Labeler crown laboratories, inc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

menthol .5 mg/1000mL, pramoxine hydrochloride 10 mg/1000mL

Manufacturer
Crown Laboratories, Inc

Identifiers & Regulatory

Product NDC 0316-0234
Product ID 0316-0234_483436b1-9031-4992-e063-6394a90ad0c5
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2027-12-31
Marketing Start 2024-01-05

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03160234
Hyphenated Format 0316-0234

Supplemental Identifiers

UNII
L7T10EIP3A 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 sarna (source: ndc)
Generic Name pramoxine hydrochloride, menthol (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1000mL
  • 10 mg/1000mL
source: ndc
Packaging
  • 355 mL in 1 BOTTLE, PUMP (0316-0234-12)
  • 5 mL in 1 PACKET (0316-0234-24)
  • 222 mL in 1 BOTTLE, PUMP (0316-0234-75)
source: ndc

Packages (3)

0316-0234-12 355 mL in 1 BOTTLE, PUMP (0316-0234-12) 0316-0234-24 5 mL in 1 PACKET (0316-0234-24) 0316-0234-75 222 mL in 1 BOTTLE, PUMP (0316-0234-75)

Ingredients (2)

menthol (.5 mg/1000mL) pramoxine hydrochloride (10 mg/1000mL)

Linked Drug Pages (1)

Sarna ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "483436b1-9031-4992-e063-6394a90ad0c5", "openfda": {"unii": ["L7T10EIP3A", "88AYB867L5"], "spl_set_id": ["19c41e75-a654-90cf-e063-6394a90a7e97"], "manufacturer_name": ["Crown Laboratories, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "355 mL in 1 BOTTLE, PUMP (0316-0234-12)", "package_ndc": "0316-0234-12", "marketing_start_date": "20240105"}, {"sample": true, "description": "5 mL in 1 PACKET (0316-0234-24)", "package_ndc": "0316-0234-24", "marketing_start_date": "20240313"}, {"sample": false, "description": "222 mL in 1 BOTTLE, PUMP (0316-0234-75)", "package_ndc": "0316-0234-75", "marketing_start_date": "20240105"}], "brand_name": "Sarna", "product_id": "0316-0234_483436b1-9031-4992-e063-6394a90ad0c5", "dosage_form": "LOTION", "product_ndc": "0316-0234", "generic_name": "Pramoxine Hydrochloride, Menthol", "labeler_name": "Crown Laboratories, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sarna", "active_ingredients": [{"name": "MENTHOL", "strength": ".5 mg/1000mL"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/1000mL"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240105", "listing_expiration_date": "20271231"}