DailyMed Label Change Watch Report

Pharma label-operations and regulatory-research teams provide bounded DailyMed filters such as drug names, labelers, NDCs, application numbers, or Set IDs.
The Actor compares public SPL metadata and version history across recurring runs.
The result is a source-linked change alert, impact report, or compact export; full label XML/PDF/media is excluded by default.

Run the next report

• Medicare Coverage Change Impact Report for public national coverage document changes.
• CMS Provider Ownership & Quality Change Report for source-linked provider ownership and quality changes.
• FDA 510(k) Device Clearance Landscape Report for public device clearance record changes.

Store Quickstart

1. Start with initialRunMode: "baseline_only" and a stable monitorKey.
2. Use a stable watches[].id, set generateReport: true, and leave emitUnchanged: false.
3. After the free baseline, run the same watch again. Only new or changed metadata/version observations produce billable output.

The first recurring run stores a baseline and emits 0 rows / 0 charge. An unchanged recurring run emits zero rows and zero charge. The default value path is report-first and does not download full labels.

Example 1: Drug-name portfolio watch

{
  "watches": [{
    "id": "acetaminophen-labels",
    "drugNames": ["acetaminophen"],
    "publishedDateFrom": "2024-01-01",
    "publishedDateComparison": "gte"
  }],
  "monitorKey": "acetaminophen-label-portfolio",
  "initialRunMode": "baseline_only",
  "generateReport": true,
  "emitRawRows": false,
  "emitExport": false,
  "emitUnchanged": false,
  "maxRecordsPerWatch": 10,
  "maxHistoryEntries": 5,
  "maxChargeUsd": 25
}

Example 2: Exact Set ID watch

{
  "watches": [{
    "id": "known-spl",
    "setIds": ["1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8"]
  }],
  "monitorKey": "known-spl-version-watch",
  "initialRunMode": "baseline_only",
  "includeHistory": true,
  "generateReport": true,
  "emitUnchanged": false,
  "maxChargeUsd": 25
}

Example 3: Labeler and application watch

{
  "watches": [{
    "id": "labeler-nda-portfolio",
    "labelers": ["Example Labeler"],
    "applicationNumbers": ["NDA012345"],
    "publishedDateFrom": "2025-01-01",
    "publishedDateComparison": "gte"
  }],
  "monitorKey": "labeler-nda-portfolio",
  "initialRunMode": "emit_backfill",
  "generateReport": true,
  "emitExport": true,
  "emitUnchanged": false,
  "maxRecordsPerWatch": 25,
  "maxHistoryEntries": 10,
  "maxChargeUsd": 25
}

What you receive

The report-first output can contain:

• dailymed-label-impact-report: grouped counts and source-linked evidence for new or changed records.
• dailymed-label-change-alert: one alert per new label or metadata/version change.
• dailymed-label-export: compact JSON-ready metadata and version history without full label content.
• dailymed-label-row: optional low-priced metadata row when emitRawRows is enabled.

Each label includes setId, title, SPL version, published date, labeler when present, bounded history, DailyMed metadata URL, and official history URL. The actor never treats a missing history entry as proof that no change exists.

Pricing

Event	Price	When it is emitted
dailymed-label-row	$0.005	Optional compact row for a new or changed observation
dailymed-label-change-alert	$0.20	New or changed metadata/version observation
dailymed-label-impact-report	$10.00	One grouped report for the selected changes
dailymed-label-export	$6.00	Optional compact source-linked export

maxChargeUsd is enforced before delivery. Unknown event names, delivery failures, missing charge receipts, and state-store failures fail closed. State is committed only after all billable rows have been delivered successfully.

Compliance and data boundary

• Uses official DailyMed Web Services v2 GET endpoints only. No API key, login, cookie, or paid service is required.
• Retrieves the /spls metadata list and bounded /spls/{SETID}/history metadata. It does not fetch or redistribute full label XML, ZIP, PDF, or media by default.
• This is descriptive public-record monitoring, not medical, clinical, legal, regulatory, pharmacovigilance, investment, procurement, or market-access advice.
• A metadata/version change is not a causality finding, safety conclusion, efficacy conclusion, treatment recommendation, approval prediction, or guarantee.
• The product is not endorsed by, approved by, or affiliated with FDA, NLM, NIH, or HHS. Verify the official record before acting.

Support files

• docs/source-compliance.md
• docs/store-competitive-snapshot.md
• docs/integration-guide.md
• docs/sample-output.json