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 · 5

ndc11
5241228502
1 TUBE in 1 CARTON (52412-285-02) / 56 g in 1 TUBE
ndc11
5241228503
1 TUBE in 1 CARTON (52412-285-03) / 85 g in 1 TUBE
ndc11
5241228504
1 TUBE in 1 CARTON (52412-285-04) / 113 g in 1 TUBE
ndc11
5241228512
340 g in 1 JAR (52412-285-12)
ndc11
5241228516
453 g in 1 JAR (52412-285-16)

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": "52412-285_29577ef9-f215-1dc6-e063-6394a90a44ab",
  "productndc": "52412-285",
  "dosage_form": "CREAM",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ZINC OXIDE",
  "proprietary_name": "Balmex Diaper Rash",
  "active_ingred_unit": "g/100g",
  "application_number": "M016",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Zinc Oxide 11.3%",
  "start_marketing_date": "20210419",
  "active_numerator_strength": "11.3"
}

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