x-treme freeze

Generic: cold therapy gel

Labeler: dynarex corporation
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name x-treme freeze
Generic Name cold therapy gel
Labeler dynarex corporation
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

menthol 4 g/100mL

Manufacturer
Dynarex Corporation

Identifiers & Regulatory

Product NDC 67777-144
Product ID 67777-144_48fdd7f5-f062-0f63-e063-6294a90a452a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2027-12-31
Marketing Start 2018-08-17

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67777144
Hyphenated Format 67777-144

Supplemental Identifiers

RxCUI
415974
UPC
0616784144412 0616784144214 0616784144122 0616784144719
UNII
L7T10EIP3A

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 x-treme freeze (source: ndc)
Generic Name cold therapy gel (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 4 g/100mL
source: ndc
Packaging
  • 200 BOX in 1 CASE (67777-144-10) / 100 PACKET in 1 BOX (67777-144-11) / 3 mL in 1 PACKET
  • 24 TUBE in 1 CASE (67777-144-20) / 118 mL in 1 TUBE (67777-144-21)
  • 12 BOTTLE, PUMP in 1 CASE (67777-144-40) / 473 mL in 1 BOTTLE, PUMP (67777-144-41)
  • 2 BOTTLE, PLASTIC in 1 CASE (67777-144-70) / 3785 mL in 1 BOTTLE, PLASTIC (67777-144-71)
source: ndc

Packages (4)

67777-144-10 200 BOX in 1 CASE (67777-144-10) / 100 PACKET in 1 BOX (67777-144-11) / 3 mL in 1 PACKET 67777-144-20 24 TUBE in 1 CASE (67777-144-20) / 118 mL in 1 TUBE (67777-144-21) 67777-144-40 12 BOTTLE, PUMP in 1 CASE (67777-144-40) / 473 mL in 1 BOTTLE, PUMP (67777-144-41) 67777-144-70 2 BOTTLE, PLASTIC in 1 CASE (67777-144-70) / 3785 mL in 1 BOTTLE, PLASTIC (67777-144-71)

Ingredients (1)

menthol (4 g/100mL)

Linked Drug Pages (1)

X-Treme Freeze ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "48fdd7f5-f062-0f63-e063-6294a90a452a", "openfda": {"upc": ["0616784144412", "0616784144214", "0616784144122", "0616784144719"], "unii": ["L7T10EIP3A"], "rxcui": ["415974"], "spl_set_id": ["79f0802f-03ad-bf8f-e053-2991aa0ae4b5"], "manufacturer_name": ["Dynarex Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "200 BOX in 1 CASE (67777-144-10)  / 100 PACKET in 1 BOX (67777-144-11)  / 3 mL in 1 PACKET", "package_ndc": "67777-144-10", "marketing_start_date": "20180817"}, {"sample": false, "description": "24 TUBE in 1 CASE (67777-144-20)  / 118 mL in 1 TUBE (67777-144-21)", "package_ndc": "67777-144-20", "marketing_start_date": "20180817"}, {"sample": false, "description": "12 BOTTLE, PUMP in 1 CASE (67777-144-40)  / 473 mL in 1 BOTTLE, PUMP (67777-144-41)", "package_ndc": "67777-144-40", "marketing_start_date": "20180817"}, {"sample": false, "description": "2 BOTTLE, PLASTIC in 1 CASE (67777-144-70)  / 3785 mL in 1 BOTTLE, PLASTIC (67777-144-71)", "package_ndc": "67777-144-70", "marketing_start_date": "20180817"}], "brand_name": "X-Treme Freeze", "product_id": "67777-144_48fdd7f5-f062-0f63-e063-6294a90a452a", "dosage_form": "GEL", "product_ndc": "67777-144", "generic_name": "Cold Therapy Gel", "labeler_name": "Dynarex Corporation", "product_type": "HUMAN OTC DRUG", "brand_name_base": "X-Treme Freeze", "active_ingredients": [{"name": "MENTHOL", "strength": "4 g/100mL"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180817", "listing_expiration_date": "20271231"}