United States· US:42681-0056_453b1f6c-767a-9c4c-e063-6394a90a81b2

Allergy Relief

A piperazine derivatives product containing cetirizine hcl, registered in United States by Whole Foods Market, INC..

ATC R06AEOrange BookUS label

Checked against FDA National Drug Code directory (United States) on September 12, 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: Cetirizine HCl
Manufacturer: Whole Foods Market, INC.
Country: United States (US)
ATC code: R06AE
ATC class: Piperazine derivatives
Reimbursed: Not published by this register
Source register: FDA National Drug Code directory (United States)
Last checked: September 12, 2026

Packs & prices · 2

ndc11
4268100561
1 BOTTLE, PLASTIC in 1 CARTON (42681-0056-1) / 30 CAPSULE in 1 BOTTLE, PLASTIC
ndc11
4268100562
1 BOTTLE, PLASTIC in 1 CARTON (42681-0056-2) / 90 CAPSULE in 1 BOTTLE, PLASTIC

Regulatory notes

UNII (FDA substance ID)

64O047KTOA

CETIRIZINE HYDROCHLORIDE

RxCUI 203150

Orange Book

N022429

DailyMed SPL labels

1 version tracked

Same medicine, other countries

Cetirizine hcl in 16 other countries

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

All cetirizine hcl products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

Austria · Cetiristad, Cetirizin Actavis
Belgium · Cetirizin Ab, Cetirizine Eg
Bulgaria · Алертесин, Зиртек
Cyprus · Agelmin, Temelin
Czechia · Allcerin, Analergin
Germany · Cetidex, Cetirizin 1 A Pharma
Denmark · Alnok, Benaday
Estonia · Aceterin, Aceterin Express
Spain · Alercina, Alerlisin
Finland · Cetimax, Cetirizin Ratiopharm
France · Alairgix Allergie, Cetirizine Almus
United Kingdom (Northern Ireland) · Allacan, Allergy And Hayfever Relief
Greece · Agelmin, Cetirgen
Croatia · Letizen, Letizen S
Hungary · Cetimax, Cetirizin 1 A Pharma
Ireland · Anti-Hist Allergy, Cetirelief Allergy
Iceland · Cetirizin Stada, Histasin
Italy · Axeramis, Cerchio
Lithuania · Aceterin, Aceterin Express
Luxembourg · Cetirizine Eg, Reactine
Latvia · Aceterin, Alyr
Malta · Anti-Hist Allergy, Cetirizine Aurobindo
Netherlands · Allergietabletten Cetirizine Dihcl Htp, Cetirizine 2hcl Teva
Norway · Cetimax, Cetirizin Norfri
Poland · Alermed, Alerzina
Portugal · Allertek, Cetirizina Alter Genéricos
Romania · Allemax, Celerg
Sweden · Cetimax, Cetirizin Abece
Slovenia · Cetirizin Pharmasan, Cetixin
Slovakia · Alerid, Cetirizin Dr.Max

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/e5b8957a-4808-4ff4-8b11-13429a4fe1eb
GET /v1/drugs/e5b8957a-4808-4ff4-8b11-13429a4fe1eb?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": "64O047KTOA",
    "rxcui": "203150",
    "inchikey": "PGLIUCLTXOYQMV-UHFFFAOYSA-N",
    "display_name": "CETIRIZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 3
  },
  "spl_meta": {
    "934c7b91-3cba-47f0-8efa-77216f3f15c4": {
      "match": "brand_token",
      "title": "ALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [AMERISOURCE BERGEN]",
      "spl_version": "14",
      "published_date": "2026-06-01"
    }
  },
  "productid": "42681-0056_453b1f6c-767a-9c4c-e063-6394a90a81b2",
  "productndc": "42681-0056",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "022429",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jul 23, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jul 23, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Jul 23, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Jul 23, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "Allergy Relief",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022429",
  "marketing_category": "NDA",
  "nonproprietary_name": "Cetirizine HCl",
  "start_marketing_date": "20251209",
  "active_numerator_strength": "10"
}

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