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United States · US · US:51467-007_4abdf7dc-664a-a821-e063-6294a90aa868

COLTALIN-DM

In shortageUNIISPLATC N02BE

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

Identification

ManufacturerFORTUNE PHARMACAL COMPANY LIMITED
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5146700701
    2 BLISTER PACK in 1 BOX (51467-007-01) / 12 TABLET in 1 BLISTER PACK
  • ndc11
    5146700702
    3 BLISTER PACK in 1 BOX (51467-007-02) / 12 TABLET in 1 BLISTER PACK

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": {
    "33e1bec0-323b-40b7-809a-cb65a71ad0ce": {
      "match": "brand_token",
      "title": "COLTALIN-DM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) TABLET [FORTUNE PHARMACAL COMPANY LIMITED]",
      "spl_version": "3",
      "published_date": "2026-02-16"
    }
  },
  "productid": "51467-007_4abdf7dc-664a-a821-e063-6294a90aa868",
  "productndc": "51467-007",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "COLTALIN-DM",
  "active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE",
  "start_marketing_date": "20260130",
  "active_numerator_strength": "325; 2; 10; 5"
}

Related drugs

Other records sharing ATC code N02BE.

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