United States· US:81665-104_fd09b0f1-907c-4d4d-a693-9756efd60f20

CROMOLYN SODIUM

A medicinal product containing cromolyn sodium, registered in United States by Omnivium Pharmaceuticals LLC.

US 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…normalisedCROMOLYN SODIUMATC—REGISTER NO.US:81665-104_fd09b0f1…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
CROMOLYN SODIUM
Manufacturer
Omnivium Pharmaceuticals LLC
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    8166510496
    12 POUCH in 1 CARTON (81665-104-96) / 8 AMPULE in 1 POUCH / 5 mL in 1 AMPULE
  • ndc11
    81665-104-96

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Cromolyn sodium in 15 other countries

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

All cromolyn sodium products

Authorised across Europe · EMA

The same active substance is authorised in 28 EEA countries. Names it is sold under:

  • Austria · Allergo-Comod, Allergocrom
  • Belgium · Allergo-Comod, Cromabak
  • Bulgaria · Lecrolyn Sine
  • Cyprus · Cromodal, Vividrin
  • Czechia · Allergo-Comod, Allergocrom
  • Germany · Allergoval, Cromo
  • Denmark · Lecrolyn Sine, Lomudal
  • Estonia · Lecrolyn, Lecrolyn Sine
  • Spain · Gastrofrenal
  • Finland · Lecrolyn, Lecrolyn Sine
  • France · Alairgix Rhinite Allergique, Allergocomod
  • United Kingdom (Northern Ireland) · Alleopti Allergy, Alleopti Hayfever
  • Greece · Allergotin, Chromoprol
  • Hungary · Lecrolyn, Taleum
  • Ireland · Opticrom, Opticrom Allergy
  • Iceland · Lecrolyn Sine, Lomudal
  • Italy · Brunicrom, Lecrosine
  • Lithuania · Lecrolyn, Lecrolyn Sine
  • Luxembourg · Allergo-Comod, Cromabak
  • Latvia · Lecrolyn Sine
  • Malta · Allergo-Comod, Allergotin
  • Netherlands · Allerg-Abak, Allergieneusspray Natriumcromoglicaat Etos
  • Norway · Lecrolyn Sine, Lomudal
  • Poland · Allergo-Comod, Allergocrom
  • Portugal · Allergocrom, Cromabak
  • Romania · Alergorom, Lecrolyn
  • Sweden · Allgil, Lecrolyn
  • Slovakia · Allergocrom, Lecrolyn

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/fa6dc6ae-3571-4056-ba0a-6f0bbdc9b678
GET /v1/drugs/fa6dc6ae-3571-4056-ba0a-6f0bbdc9b678?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.

{
  "route": "ORAL",
  "source": "ndc",
  "strength": "100",
  "substance": "CROMOLYN SODIUM",
  "productndc": "81665-104",
  "dosage_form": "SOLUTION, CONCENTRATE",
  "dea_schedule": null,
  "strength_unit": "mg/5mL",
  "application_number": "ANDA209264",
  "marketing_category": "ANDA"
}

See everything about cromolyn sodium.

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.