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United States · US · US:69498-003_2b4cfd5e-bd83-534d-e063-6394a90a598c

iSmile Topical Anesthetic

UNIISPLATC D04AB04

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

Identification

ManufactureriSmile Dental Products, Inc.
CountryUS (United States)
ATC codeD04AB04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6949800330
    30 g in 1 JAR (69498-003-30)

Annotations

UNII (FDA Substance ID)
U3RSY48JW5
BENZOCAINE
RxCUI 1399
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "U3RSY48JW5",
    "rxcui": "1399",
    "inchikey": "BLFLLBZGZJTVJG-UHFFFAOYSA-N",
    "display_name": "BENZOCAINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "DENTAL",
  "spl_meta": {
    "be558e5b-cf35-4035-a69c-8d66deeac6b2": {
      "match": "brand_token",
      "title": "ISMILE TOPICAL ANESTHETIC (BENZOCAINE) GEL [ISMILE DENTAL PRODUCTS, INC.]",
      "spl_version": "4",
      "published_date": "2025-01-13"
    }
  },
  "productid": "69498-003_2b4cfd5e-bd83-534d-e063-6394a90a598c",
  "productndc": "69498-003",
  "dosage_form": "GEL",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "BENZOCAINE",
  "proprietary_name": "iSmile Topical Anesthetic",
  "active_ingred_unit": "mg/g",
  "application_number": "M022",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Benzocaine",
  "start_marketing_date": "20140601",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code D04AB04.

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