Current NDC auxiliary source row compounder:1685

This page is keyed by dataset, FDA.report source record ID, and physical source row number. Empty values are shown rather than omitted.

Complete normalized row#

Record Source: ndc_compounder_zip
Product Ndc Raw: 85974-131
Product Ndc: 85974-131
Product Ndc Digits: 85974131
Product Type Name: HUMAN COMPOUNDED DRUG
Proprietary Name: Orlicaine Gel - Mint
Proprietary Name Suffix: [empty]
Nonproprietary Name: tetracaine hcl 4%, bupivacaine hcl 0.5%, phenylephrine hcl 1% gel
Dosage Form Name: GEL
Route Name: TOPICAL
Marketing Category Name: OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Name: Bennett Pharmaceuticals of America, LLC
Establishment Name: Bennett Pharmaceuticals of America, LLC
Establishment Fei: [empty]
Substance Name: TETRACAINE HYDROCHLORIDE; BUPIVACAINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredients Info: 40 mg/1 mL; 5 mg/1 mL; 10 mg/1 mL
History Active Ingredients Raw: TETRACAINE HYDROCHLORIDE; BUPIVACAINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
History Active Ingredients Info Raw: 40 mg/1 mL; 5 mg/1 mL; 10 mg/1 mL
History Dosage Raw: GEL
Dea Schedule: [empty]
Package Ndc Raw: 85974-131-52
Package Ndc: 85974-131-52
Package Ndc Digits: 8597413152
Package Ndc11: 85974013152
Package Description: 12 mL in 1 JAR (85974-131-52)
Reporting Period Raw: 2025-2
Reporting Period: 2025-2
Normalization Status: valid
Source Url: https://www.accessdata.fda.gov/cder/compounders_ndc_directory.zip
Source Archive: compounders_ndc_directory.zip
Source File: compounders_ndc_directory.txt
Source Date: 2026-09-18
Source Last Modified: Fri, 18 Sep 2026 15:17:23 GMT
Source Archive Sha256: 222f6800f79cb1a0fa79431b7226bd6b34899999dbf086af51004a96774ada98
Source Member Sha256: f8d9743e5616579a34d614887e86a53913efa0a63d3138d59d2f87cbb4d0cc17
Source Record Id: compounder:1685
Source Row Number: 1685
Source Row Hash: 6582f7adf79caf72987310de1cc03a225f2eb6406dd81f778072deb9309aba76
Import Run Id: 20261022T045816Z
Loaded At: 2026-10-22 05:03:38

Exact raw FDA source fields#

{
    "ROUTENAME": "TOPICAL",
    "PRODUCTNDC": "85974-131",
    "DEASCHEDULE": "",
    "LABELERNAME": "Bennett Pharmaceuticals of America, LLC",
    "SUBSTANCENAME": "TETRACAINE HYDROCHLORIDE; BUPIVACAINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
    "DOSAGEFORMNAME": "GEL",
    "NDCPACKAGECODE": "85974-131-52",
    "PRODUCTTYPENAME": "HUMAN COMPOUNDED DRUG",
    "PROPRIETARYNAME": "Orlicaine Gel - Mint",
    "REPORTINGPERIOD": "2025-2",
    "NONPROPRIETARYNAME": "tetracaine hcl 4%, bupivacaine hcl 0.5%, phenylephrine hcl 1% gel",
    "PACKAGEDESCRIPTION": "12 mL in 1 JAR (85974-131-52) ",
    "ACTIVEINGREDIENTSINFO": "40 mg/1 mL; 5 mg/1 mL; 10 mg/1 mL",
    "MARKETINGCATEGORYNAME": "OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)",
    "PROPRIETARYNAMESUFFIX": ""
}

Normalization notes#

[]

Current status projection#

Dataset: compounder
Record Source: ndc_compounder_zip
Source Record Id: compounder:1685
Source Row Number: 1685
Status Scope: package
Lookup Ndc: 85974-131-52
Lookup Ndc Digits: 8597413152
Product Ndc: 85974-131
Product Ndc Digits: 85974131
Package Ndc: 85974-131-52
Package Ndc Digits: 8597413152
Package Ndc11: 85974013152
Product Id: [empty]
Status Code: COMPOUNDER
Status Label: Outsourcing facility compounded drug report
Reporting Period Raw: 2025-2
Reporting Period: 2025-2
Source Table: fda_ndc_aux_compounder
Source File: compounders_ndc_directory.txt
Source Date: 2026-09-18
Source Row Hash: 6582f7adf79caf72987310de1cc03a225f2eb6406dd81f778072deb9309aba76
Import Run Id: 20261022T045816Z
Loaded At: 2026-10-22 05:03:38