United States· US:70000-0191_216b2b43-c73d-4caf-91ce-75eb63e78301

Leader Daytime Cold and Flu

A anilides product containing acetaminophen, dextromethorphan hbr, phenylephrine hcl, registered in United States by Cardinal Health 110, LLC. dba Leader.

In shortageATC N02BEUS label

Checked against FDA National Drug Code directory (United States) on June 3, 2026

Informational only — not a medical device.

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The record

At a glance

FDA National Drug Code directory (United States)

Active substance: acetaminophen, dextromethorphan Hbr, Phenylephrine HCl
Manufacturer: Cardinal Health 110, LLC. dba Leader
Country: United States (US)
ATC code: N02BE
ATC class: Anilides
Reimbursed: Not published by this register
Source register: FDA National Drug Code directory (United States)
Last checked: June 3, 2026

Packs & prices · 2

ndc11
7000001911
237 mL in 1 BOTTLE (70000-0191-1)
ndc11
7000001912
355 mL in 1 BOTTLE (70000-0191-2)

Regulatory notes

UNII (FDA substance ID)

362O9ITL9D

ACETAMINOPHEN

RxCUI 161

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Acetaminophen; Oxycodone Hydrochloride Tablet

Same class

Other records under N02BE

Anilides, as other registers publish it.

All acetaminophen, dextromethorphan hbr, phenylephrine hcl products

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload

GET /v1/drugs/fbd73e00-a5aa-42e7-b66f-9bf1a805996c
GET /v1/drugs/fbd73e00-a5aa-42e7-b66f-9bf1a805996c?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "unii": {
    "unii": "362O9ITL9D",
    "rxcui": "161",
    "inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
    "display_name": "ACETAMINOPHEN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "12971fb2-2314-4443-bf70-b7eb5859b148": {
      "match": "brand_token",
      "title": "LEADER MUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]",
      "spl_version": "3",
      "published_date": "2026-06-01"
    }
  },
  "productid": "70000-0191_216b2b43-c73d-4caf-91ce-75eb63e78301",
  "productndc": "70000-0191",
  "dosage_form": "SOLUTION",
  "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": "Leader Daytime Cold and Flu",
  "active_ingred_unit": "mg/15mL; mg/15mL; mg/15mL",
  "application_number": "M017",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "acetaminophen, dextromethorphan Hbr, Phenylephrine HCl",
  "start_marketing_date": "20161214",
  "active_numerator_strength": "325; 10; 5"
}

API reference MCP server Plans

See everything about acetaminophen, dextromethorphan hbr, phenylephrine hcl.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.

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