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United States · US · US:85284-008_3c404ff7-8b89-9f6b-e063-6294a90a2d91

Numbing cream

UNIISPLATC D04AB07

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

Identification

ManufacturerBLOOMWELL GARDENS LLC
CountryUS (United States)
ATC codeD04AB07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8528400801
    50 g in 1 BOTTLE (85284-008-01)

Annotations

UNII (FDA Substance ID)
88AYB867L5
PRAMOXINE HYDROCHLORIDE
RxCUI 57555
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "88AYB867L5",
    "rxcui": "57555",
    "inchikey": "SYCBXBCPLUFJID-UHFFFAOYSA-N",
    "display_name": "PRAMOXINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "4ce416dd-2430-4648-e063-6294a90ab199": {
      "match": "brand_token",
      "title": "NUMBING (MENTHOL) CREAM [FLEXIGO INC]",
      "spl_version": "1",
      "published_date": "2026-03-30"
    }
  },
  "productid": "85284-008_3c404ff7-8b89-9f6b-e063-6294a90a2d91",
  "productndc": "85284-008",
  "dosage_form": "CREAM",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "PRAMOXINE HYDROCHLORIDE",
  "proprietary_name": "Numbing cream",
  "active_ingred_unit": "g/100g",
  "application_number": "M017",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Pramoxine Hydrochloride 1%",
  "start_marketing_date": "20250813",
  "active_numerator_strength": "1"
}

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