FDA.reportPublic FDA data

Allergy Desensitization

Product NDC
80961-125
Requested package NDC
80961-125-10
11-digit product format
809610125
Labeler code
80961
Product ID
80961-125_d57bb194-eb6c-360d-e053-2995a90af939
Type
HUMAN OTC DRUG
Nonproprietary name
Onion, Apis Mellifera, Schoenocaulon Officinale Seed, Euphrasia Stricta
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
Peak Manufacturing and Fulfillment Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-07-06
Marketing end
0000-00-00
Substance
ONION; APIS MELLIFERA; SCHOENOCAULON OFFICINALE SEED; EUPHRASIA STRICTA
Active strength
6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage80961-12580961-125-10IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80961-125-102024-01-30C16284748780-11030e365-4ca5-111a-e063-dadaa90a10e2Allergy Desensitization

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80961-125-10Allergy Desensitization1 in 1 PACKAGELIQUID12
80961-125-10Allergy Desensitization10 mL in 1 BOTTLE, DROPPERLIQUID102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80961-125ALLERGY DESENSITIZATION (ONION, APIS MELLIFERA, SCHOENOCAULON OFFICINALE SEED, EUPHRASIA STRICTA) LIQUID [PEAK MANUFACTURING AND FULFILLMENT INC]2Legacy NDC, 2 package rows20220114_b234e0b1-538b-5750-e053-2995a90a517f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80961-125-10809610125101 BOTTLE, DROPPER in 1 PACKAGE (80961-125-10) > 10 mL in 1 BOTTLE, DROPPER2020-07-060000-00-00NoNoCurrent