Back to search
🇺🇸

United States · US · US:63135-581_47e9cb0c-dbdb-3ee0-e063-6394a90a9052

TOPICAINE 5

In shortageUNIISPLATC R02AD02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerESBA LABORATORIES INC.
CountryUS (United States)
ATC codeR02AD02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6313558104
    113 g in 1 TUBE (63135-581-04)
  • ndc11
    6313558110
    1 TUBE in 1 BOX (63135-581-10) / 10 g in 1 TUBE
  • ndc11
    6313558130
    1 TUBE in 1 BOX (63135-581-30) / 30 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
98PI200987
LIDOCAINE
RxCUI 6387
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Lidocaine Hydrochloride Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "98PI200987",
    "rxcui": "6387",
    "inchikey": "NNJVILVZKWQKPM-UHFFFAOYSA-N",
    "display_name": "LIDOCAINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "e052f718-700a-44e0-8770-65451b812ee1": {
      "match": "brand_token",
      "title": "TOPICAINE ULTRA GEL [ONCORA PHARMA, LLC]",
      "spl_version": "1",
      "published_date": "2026-03-20"
    }
  },
  "productid": "63135-581_47e9cb0c-dbdb-3ee0-e063-6394a90a9052",
  "productndc": "63135-581",
  "dosage_form": "GEL",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LIDOCAINE",
  "shortage_reason": "Lidocaine Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "TOPICAINE 5",
  "active_ingred_unit": "g/100g",
  "application_number": "M015",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "LIDOCAINE 5%",
  "start_marketing_date": "20030420",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code R02AD02.

Access this data programmatically

Query TOPICAINE 5 and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.