rocainol topical analgesic

Generic: methyl salicylate, menthol

Labeler: compania internacional de comercio, s.a.p.i de c.v.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name rocainol topical analgesic
Generic Name methyl salicylate, menthol
Labeler compania internacional de comercio, s.a.p.i de c.v.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

menthol 8 g/100g, methyl salicylate 16 g/100g

Manufacturer
Compania Internacional de Comercio, S.A.P.I de C.V.

Identifiers & Regulatory

Product NDC 54312-825
Product ID 54312-825_3998129b-973b-ecad-e063-6394a90acc89
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2013-09-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54312825
Hyphenated Format 54312-825

Supplemental Identifiers

RxCUI
1306905 1306910
UPC
0354312625018
UNII
L7T10EIP3A LAV5U5022Y

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 rocainol topical analgesic (source: ndc)
Generic Name methyl salicylate, menthol (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 8 g/100g
  • 16 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 PACKAGE (54312-825-01) / 45 g in 1 TUBE
source: ndc

Packages (1)

54312-825-01 1 TUBE in 1 PACKAGE (54312-825-01) / 45 g in 1 TUBE

Ingredients (2)

menthol (8 g/100g) methyl salicylate (16 g/100g)

Linked Drug Pages (1)

Rocainol TOPICAL ANALGESIC ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3998129b-973b-ecad-e063-6394a90acc89", "openfda": {"upc": ["0354312625018"], "unii": ["L7T10EIP3A", "LAV5U5022Y"], "rxcui": ["1306905", "1306910"], "spl_set_id": ["827ec7b2-3d87-47e0-a47a-966b25732c32"], "manufacturer_name": ["Compania Internacional de Comercio, S.A.P.I de C.V."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 PACKAGE (54312-825-01)  / 45 g in 1 TUBE", "package_ndc": "54312-825-01", "marketing_start_date": "20190530"}], "brand_name": "Rocainol TOPICAL ANALGESIC", "product_id": "54312-825_3998129b-973b-ecad-e063-6394a90acc89", "dosage_form": "OINTMENT", "product_ndc": "54312-825", "generic_name": "METHYL SALICYLATE, MENTHOL", "labeler_name": "Compania Internacional de Comercio, S.A.P.I de C.V.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Rocainol TOPICAL ANALGESIC", "active_ingredients": [{"name": "MENTHOL", "strength": "8 g/100g"}, {"name": "METHYL SALICYLATE", "strength": "16 g/100g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20130930", "listing_expiration_date": "20261231"}