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United States· US:53462-915_419e18cd-fa52-b78d-e063-6294a90a467c

Comfort Shield Barrier

A dimeticone product containing dimethicone, registered in United States by Sage Products LLC. The same ATC class is registered in 5 of our 19 countries.

ATC P03AX05US 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…normalisedComfort Shield BarrierATCP03AX05REGISTER NO.US:53462-915_419e18cd…PACKS LISTED4CHECKEDJune 3, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about dimethiconeAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Dimeticone is registered in 5 of 19 countries.

Countries holding a registration under ATC P03AX05 (dimeticone), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 1 of them publish a price we can compare per daily dose
Search dimeticone products by name

Dimeticone · ATC P03AX05

5 / 19 countries

  • Canada
  • Germany
  • Japan
  • United Kingdom
  • 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.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
dimethicone
Manufacturer
Sage Products LLC
Country
United States (US)
ATC code
P03AX05
ATC class
Dimeticone
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 4

  • ndc11
    5346291524
    24 APPLICATOR in 1 PACKAGE (53462-915-24) / 24 g in 1 APPLICATOR
  • ndc11
    5346291550
    3 APPLICATOR in 1 PACKAGE (53462-915-50) / 26 g in 1 APPLICATOR
  • ndc11
    5346291551
    3 APPLICATOR in 1 PACKAGE (53462-915-51) / 19 g in 1 APPLICATOR
  • ndc11
    5346291580
    8 APPLICATOR in 1 PACKAGE (53462-915-80) / 27 g in 1 APPLICATOR

Regulatory notes

DailyMed SPL labels
1 version tracked

Same medicine, other countries

Dimeticone in 6 other countries

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

All dimeticone products

Authorised across Europe · EMA

The same active substance is authorised in 6 EEA countries. Names it is sold under:

  • Germany · Sab Simplex
  • Finland · Cuplaton
  • France · Polysilane
  • United Kingdom (Northern Ireland) · Hedrin
  • Ireland · Dentinox Infant Colic Drops
  • Poland · Esputicon

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/aec9944c-9f0b-462a-af4b-63131240f33e
GET /v1/drugs/aec9944c-9f0b-462a-af4b-63131240f33e?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": "TOPICAL",
  "spl_meta": {
    "220209c1-18ab-1b78-e054-00144ff8d46c": {
      "match": "brand_token",
      "title": "COMFORT FOR COLIC (COMFORT FOR KIDS) LIQUID [VITALITY WORKS, INC.]",
      "spl_version": "8",
      "published_date": "2025-12-19"
    }
  },
  "productid": "53462-915_419e18cd-fa52-b78d-e063-6294a90a467c",
  "productndc": "53462-915",
  "dosage_form": "CLOTH",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DIMETHICONE",
  "proprietary_name": "Comfort Shield Barrier",
  "active_ingred_unit": "mg/g",
  "application_number": "M016",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "dimethicone",
  "start_marketing_date": "19900101",
  "active_numerator_strength": "30"
}
API referenceMCP serverPlans

See everything about dimeticone.

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.

Try it freeOpen in the console