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NDC 59316-0102-80 BIOFREEZE 40 mg/mL Details
BIOFREEZE 40 mg/mL
BIOFREEZE is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is MENTHOL, UNSPECIFIED FORM.
Product Information
| NDC | 59316-0102 |
|---|---|
| Product ID | 59316-102_0a0e1685-b635-7e21-e063-6394a90a5324 |
| Associated GPIs | 90070060004020 |
| GCN Sequence Number | 071158 |
| GCN Sequence Number Description | menthol GEL (ML) 4 % TOPICAL |
| HIC3 | L6A |
| HIC3 Description | IRRITANTS/COUNTER-IRRITANTS |
| GCN | 34864 |
| HICL Sequence Number | 002608 |
| HICL Sequence Number Description | MENTHOL |
| Brand/Generic | Generic |
| Proprietary Name | BIOFREEZE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | MENTHOL |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 40 |
| Active Ingredient Units | mg/mL |
| Substance Name | MENTHOL, UNSPECIFIED FORM |
| Labeler Name | RB Health (US) LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH DRUG |
| Application Number | M017 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 59316-0102-80 (59316010280)
| NDC Package Code | 59316-102-80 |
|---|---|
| Billing NDC | 59316010280 |
| Package | 44 mL in 1 TUBE (59316-102-80) |
| Marketing Start Date | 2018-11-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |