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United States · US · US:76281-304_2fc9865d-66d5-4fb0-9ea8-82f5981b6562

XL-3 Day Time

In shortageUNIISPLATC N02BE

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

Identification

ManufacturerAptaPharma Inc.
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7628130428
    354 mL in 1 BOTTLE, PLASTIC (76281-304-28)

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Acetaminophen; Oxycodone Hydrochloride Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "362O9ITL9D",
    "rxcui": "161",
    "inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
    "display_name": "ACETAMINOPHEN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "03210929-331e-462d-b566-4e1865f52246": {
      "match": "brand_token",
      "title": "XL-3 NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [RNV LLC]",
      "spl_version": "3",
      "published_date": "2026-01-30"
    }
  },
  "productid": "76281-304_2fc9865d-66d5-4fb0-9ea8-82f5981b6562",
  "productndc": "76281-304",
  "dosage_form": "LIQUID",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "XL-3 Day Time",
  "active_ingred_unit": "mg/15mL; mg/15mL; mg/15mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL",
  "start_marketing_date": "20180101",
  "active_numerator_strength": "325; 10; 5"
}

Related drugs

Other records sharing ATC code N02BE.

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