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United States · US · US:51672-2115_49e3a099-4616-d038-e063-6394a90a90a6

Feverall

Orange BookUNIISPLATC N02BE51

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeN02BE51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5167221152
    6 BLISTER PACK in 1 CARTON (51672-2115-2) / 1 SUPPOSITORY in 1 BLISTER PACK (51672-2115-0)
  • ndc11
    5167221154
    50 BLISTER PACK in 1 CARTON (51672-2115-4) / 1 SUPPOSITORY in 1 BLISTER PACK (51672-2115-0)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
N018337
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "362O9ITL9D",
    "rxcui": "161",
    "inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
    "display_name": "ACETAMINOPHEN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RECTAL",
  "spl_meta": {
    "861e2987-5473-45b0-b2a6-f980a9b0e809": {
      "match": "brand_token",
      "title": "FEVERALL CHILDRENS (ACETAMINOPHEN) SUPPOSITORY [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
      "spl_version": "7",
      "published_date": "2026-02-04"
    }
  },
  "productid": "51672-2115_49e3a099-4616-d038-e063-6394a90a90a6",
  "productndc": "51672-2115",
  "dosage_form": "SUPPOSITORY",
  "orange_book": {
    "appl_no": "018337",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "650MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "325MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "120MG",
        "product_no": "003",
        "approval_date": "Sep 12, 1983"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "80MG",
        "product_no": "004",
        "approval_date": "Aug 26, 1992"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN",
  "proprietary_name": "Feverall",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA018337",
  "marketing_category": "NDA",
  "nonproprietary_name": "Acetaminophen",
  "start_marketing_date": "20131212",
  "active_numerator_strength": "120"
}

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