United States· US:83324-073_33e7d855-6253-4ddc-a375-ef769eb16651

Sinus Congestion

A phenylephrine product containing phenylephrine hcl, registered in United States by Chain Drug Marketing Association, Inc.. The same ATC class is registered in 2 of our 19 countries.

ATC R01AA04US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedSinus CongestionATCR01AA04REGISTER NO.US:83324-073_33e7d855…PACKS LISTED2CHECKEDSeptember 12, 2026

Where it is registered

Phenylephrine is registered in 2 of 19 countries.

Countries holding a registration under ATC R01AA04 (phenylephrine), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 2 of them publish a price we can compare per daily dose

Phenylephrine · ATC R01AA04

2 / 19 countries

  • Finlandprice
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

Price per daily dose

What a daily dose of phenylephrine costs, country by country.

Normalised to the WHO defined daily dose (4 mg), so markets compare like for like.

  • United States: $0.020 per daily dose (median across products in the class)
  • Public list prices, converted to USD at the rate date shown

Phenylephrine · price per daily dose (4 mg)

USD · FX 28 Sept 2026

  • US United States$0.020 (acquisition cost)
Median listed price per WHO defined daily dose, in each market that publishes a price. US = pharmacy acquisition cost (CMS NADAC), not a retail price. Open the full comparison

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Phenylephrine HCl
Manufacturer
Chain Drug Marketing Association, Inc.
Country
United States (US)
ATC code
R01AA04
ATC class
Phenylephrine
Defined daily dose
4 mg, N
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 2

  • ndc11
    8332407318
    1 BLISTER PACK in 1 CARTON (83324-073-18) / 18 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    8332407336
    2 BLISTER PACK in 1 CARTON (83324-073-36) / 18 TABLET, FILM COATED in 1 BLISTER PACK

Regulatory notes

UNII (FDA substance ID)
04JA59TNSJ
PHENYLEPHRINE HYDROCHLORIDE
RxCUI 8164
DailyMed SPL labels
1 version tracked

Interactions

58 interactions on record for phenylephrine.

Graded by severity as the source publishes them — 8 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Phenylephrine · interactions on record

58 records

  • 8 severe
  • 50 moderate

Most severe, free to view

  • MethylergometrineG02AB01severe
  • ErgometrineG02AB03severe
  • HalothaneN01AB01severe
  • DihydroergotamineN02CA01severe
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Phenylephrine in 15 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All phenylephrine products

Authorised across Europe · EMA

The same active substance is authorised in 29 EEA countries. Names it is sold under:

  • Austria · Biorphen, Phenylephrin Aguettant
  • Belgium · Minims Fenylefrinehydrochloride Bausch + Lomb Ireland Limited, Minims Phenylephrine Chlorhydrate Bausch + Lomb Ireland Limited
  • Bulgaria · Фенилефрин Вижън, Фенилефрин Вижън Антибиотик-Разград Ад
  • Cyprus · Biorphen
  • Czechia · Neosynephrin-Pos, Phenylephrine Olikla
  • Germany · Biorphen, Neosynephrin-Pos
  • Denmark · Biorphen, Fenylefrin Abcur
  • Estonia · Biorphen
  • Spain · Colircusí, Disneumon Pernasal
  • Finland · Fenylefrin Abcur, Fenylefrin Aguettant
  • France · Neosynephrine, Phenylephrine Aguettant
  • United Kingdom (Northern Ireland) · Blocked Nose Relief, Flamingo Max Strength Congestion Relief
  • Greece · Biorphen, Phenylephrine Cooper
  • Croatia · Biorphen
  • Hungary · Biorphen
  • Ireland · Minims, Phenylephrine Hydrochloride Athlone Pharmaceuticals
  • Iceland · Biorphen, Fenylefrin Abcur
  • Italy · Fenilefrina Aguettant, Nasomixin C.M.
  • Luxembourg · Minims Phenylephrine Chlorhydrate Bausch + Lomb Ireland Limited, Minims Phenylephrinhydrochlorid Bausch + Lomb Ireland Limited
  • Latvia · Biorphen
  • Malta · Phenylephrine Laboratoire Aguettant
  • Netherlands · Fenylefrine Added Pharma, Fenylefrine Aguettant
  • Norway · Biorphen, Fenylefrin Abcur
  • Poland · Acatar Acti Form, Anosin
  • Portugal · Davinefrina, Fenilefrina Aguettant
  • Romania · Bioflu Nazal, Fenefrin
  • Sweden · Fenylefrin Abcur, Fenylefrin Aguettant
  • Slovenia · Fenilefrin Sintetica
  • Slovakia · Fenefrin, Phenylephrine Olikla

Source: European Medicines Agency, Article 57 product data.

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/12d6d80d-85ef-4c20-847a-45ce8f307bfc
GET /v1/drugs/12d6d80d-85ef-4c20-847a-45ce8f307bfc?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": "04JA59TNSJ",
    "rxcui": "8164",
    "inchikey": "OCYSGIYOVXAGKQ-FVGYRXGTSA-N",
    "display_name": "PHENYLEPHRINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 5
  },
  "spl_meta": {
    "e9dd2d7b-0a19-4a42-b51e-b9914f02406e": {
      "match": "brand_token",
      "title": "SINUS CONGESTION AND PAIN DAYTIME NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]",
      "spl_version": "15",
      "published_date": "2026-05-25"
    }
  },
  "productid": "83324-073_33e7d855-6253-4ddc-a375-ef769eb16651",
  "productndc": "83324-073",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "PHENYLEPHRINE HYDROCHLORIDE",
  "proprietary_name": "Sinus Congestion",
  "active_ingred_unit": "mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Phenylephrine HCl",
  "start_marketing_date": "20250626",
  "active_numerator_strength": "10"
}

See everything about phenylephrine.

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.