Biofreeze

UNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerReckitt Benckiser LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
5931610110
5 mL in 1 PACKET (59316-101-10)
ndc11
5931610111
30 mL in 1 BOTTLE (59316-101-11)
ndc11
5931610112
59 mL in 1 TUBE (59316-101-12)
ndc11
5931610113
59 mL in 1 BOTTLE, WITH APPLICATOR (59316-101-13)
ndc11
5931610115
89 mL in 1 BOTTLE, WITH APPLICATOR (59316-101-15)
ndc11
5931610119
3 mL in 1 PACKET (59316-101-19)
ndc11
5931610120
118 mL in 1 TUBE (59316-101-20)
ndc11
5931610130
473 mL in 1 BOTTLE, PUMP (59316-101-30)
ndc11
5931610140
946 mL in 1 BOTTLE, PUMP (59316-101-40)
ndc11
5931610150
3785 mL in 1 BOTTLE, PUMP (59316-101-50)

Annotations

UNII (FDA Substance ID)

L7T10EIP3A

MENTHOL, UNSPECIFIED FORM

RxCUI 6750

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "L7T10EIP3A",
    "rxcui": "6750",
    "inchikey": null,
    "display_name": "MENTHOL, UNSPECIFIED FORM",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "71a36691-9d9e-479d-bfdc-6f6b192ad2d0": {
      "match": "brand_token",
      "title": "BIOFREEZE MENTHOL (MENTHOL, UNSPECIFIED FORM) PATCH [RECKITT BENCKISER LLC]",
      "spl_version": "4",
      "published_date": "2026-05-28"
    }
  },
  "productid": "59316-101_51b434c9-228b-2c05-e063-6394a90a1e94",
  "productndc": "59316-101",
  "dosage_form": "GEL",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "MENTHOL, UNSPECIFIED FORM",
  "proprietary_name": "Biofreeze",
  "active_ingred_unit": "mg/mL",
  "application_number": "M017",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Menthol",
  "start_marketing_date": "20160825",
  "active_numerator_strength": "35"
}

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