Balmex Diaper Rash

UNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerRandob Labs,Ltd.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
5241240002
1 TUBE in 1 CARTON (52412-400-02) / 56 g in 1 TUBE
ndc11
5241240004
1 TUBE in 1 CARTON (52412-400-04) / 113 g in 1 TUBE
ndc11
5241240005
5.1 g in 1 PACKAGE (52412-400-05)
ndc11
5241240016
453 g in 1 JAR (52412-400-16)

Annotations

UNII (FDA Substance ID)

SOI2LOH54Z

ZINC OXIDE

RxCUI 11423

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "SOI2LOH54Z",
    "rxcui": "11423",
    "inchikey": "RNWHGQJWIACOKP-UHFFFAOYSA-N",
    "display_name": "ZINC OXIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "f7f7a89d-d4e0-9faa-e053-6294a90aaf7b": {
      "match": "brand_token",
      "title": "BALMEX DIAPER RASH (ZINC OXIDE 11.3%) CREAM [RANDOB LABS, LTD]",
      "spl_version": "3",
      "published_date": "2024-12-17"
    }
  },
  "productid": "52412-400_18af2fdd-d234-4675-afc6-e0bdd19cdbbd",
  "productndc": "52412-400",
  "dosage_form": "CREAM",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ZINC OXIDE",
  "proprietary_name": "Balmex Diaper Rash",
  "active_ingred_unit": "g/g",
  "application_number": "part347",
  "marketing_category": "OTC MONOGRAPH FINAL",
  "nonproprietary_name": "Zinc Oxide",
  "start_marketing_date": "20150427",
  "active_numerator_strength": ".113"
}

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