D-53

NDC product · U.S. Food and Drug Administration (openFDA) · United States

  • Product NDC 58264-0053
  • Package NDC 58264-0053-1
  • SPL ID 2b9ec8dd-73b0-e366-e063-6394a90ae792
  • SPL set ID 3787d569-ee4d-41de-9519-73c11b626b38
  • UNII R0JB3224WS
  • UNII SBV4XY874G
  • UNII 1MBW07J51Q
  • UNII OSD78555ZM
  • UNII 877L01IZ0P
  • UNII LC1V549NOM
  • UNII 451W47IQ8X
  • UNII 83AL37E3A7

What the source publishes

Labeler
DNA Labs, Inc.
Active ingredients
AMMONIUM BROMIDE, BROMINE, CALCIUM SULFIDE, POTASSIUM BROMIDE, RHODODENDRON TOMENTOSUM LEAFY TWIG, SODIUM BROMIDE, SODIUM CHLORIDE, and BOS TAURUS PLACENTA
Form
SOLUTION
Routes
SUBLINGUAL
Administrative status
present-in-source-snapshot
Marketing status
UNAPPROVED HOMEOPATHIC
Product type
HUMAN OTC DRUG
Prescription
Non-prescription

Names this record is found by

Complete source data
us:fda:ndc:58264-0053_2b9ec8dd-73b0-e366-e063-6394a90ae792
{
  "name": "D-53",
  "splId": "2b9ec8dd-73b0-e366-e063-6394a90ae792",
  "labels": [
    {
      "setId": "3787d569-ee4d-41de-9519-73c11b626b38",
      "labelUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3787d569-ee4d-41de-9519-73c11b626b38",
      "labelPdfUrl": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=3787d569-ee4d-41de-9519-73c11b626b38"
    }
  ],
  "routes": [
    "SUBLINGUAL"
  ],
  "labeler": "DNA Labs, Inc.",
  "finished": true,
  "packaging": [
    {
      "sample": false,
      "description": "29.57 mL in 1 BOTTLE, GLASS (58264-0053-1)",
      "package_ndc": "58264-0053-1",
      "identifierStatus": "well-formed",
      "marketing_start_date": "19900101"
    }
  ],
  "productId": "58264-0053_2b9ec8dd-73b0-e366-e063-6394a90ae792",
  "useDomain": "unknown",
  "dosageForm": "SOLUTION",
  "productNdc": "58264-0053",
  "deaSchedule": null,
  "genericName": "AMMONIUM BROMIDE, BROMINE, CALCIUM SULFIDE, POTASSIUM BROMIDE, RHODODENDRON TOMENTOSUM LEAFY TWIG, SODIUM BROMIDE, SODIUM CHLORIDE, and BOS TAURUS PLACENTA",
  "productType": "HUMAN OTC DRUG",
  "listingStatus": "present-in-source-snapshot",
  "targetSpecies": [],
  "approvalStatus": "not-established-by-ndc-listing",
  "labelAssociation": "openFDA-harmonized-set-ids; not a product-level approval match",
  "marketingEndDate": null,
  "activeIngredients": [
    {
      "name": "AMMONIUM BROMIDE",
      "strength": "12 [hp_X]/mL"
    },
    {
      "name": "BROMINE",
      "strength": "12 [hp_X]/mL"
    },
    {
      "name": "CALCIUM SULFIDE",
      "strength": "12 [hp_X]/mL"
    },
    {
      "name": "POTASSIUM BROMIDE",
      "strength": "12 [hp_X]/mL"
    },
    {
      "name": "RHODODENDRON TOMENTOSUM LEAFY TWIG",
      "strength": "12 [hp_X]/mL"
    },
    {
      "name": "SODIUM BROMIDE",
      "strength": "12 [hp_X]/mL"
    },
    {
      "name": "SODIUM CHLORIDE",
      "strength": "30 [hp_X]/mL"
    },
    {
      "name": "BOS TAURUS PLACENTA",
      "strength": "12 [hp_X]/mL"
    }
  ],
  "applicationNumber": null,
  "marketingCategory": "UNAPPROVED HOMEOPATHIC",
  "stateRestrictions": {
    "status": "not-collected",
    "observations": []
  },
  "useDomainEvidence": {
    "basis": "unreviewed",
    "field": null,
    "value": null,
    "version": 1,
    "sourceId": "us.fda.ndc"
  },
  "marketingStartDate": "19900101",
  "targetSpeciesStatus": "not-reported",
  "prescriptionCategory": "non-prescription",
  "harmonizedIdentifiers": {
    "unii": [
      "R0JB3224WS",
      "SBV4XY874G",
      "1MBW07J51Q",
      "OSD78555ZM",
      "877L01IZ0P",
      "LC1V549NOM",
      "451W47IQ8X",
      "83AL37E3A7"
    ],
    "spl_set_id": [
      "3787d569-ee4d-41de-9519-73c11b626b38"
    ],
    "manufacturer_name": [
      "DNA Labs, Inc."
    ],
    "is_original_packager": [
      true
    ]
  },
  "listingExpirationDate": "20261231"
}

Read this record from your own software

The same record, with every field and its provenance, is one request away. An API key is free and works immediately.

GET /v1/drugs/record
curl -G "https://api.medifontis.com/v1/drugs/record" \
  -H "Authorization: Bearer $MEDIFONTIS_API_KEY" \
  --data-urlencode "country=us" \
  --data-urlencode "sourceId=us.fda.ndc" \
  --data-urlencode "id=us:fda:ndc:58264-0053_2b9ec8dd-73b0-e366-e063-6394a90ae792"