Earache

Product NDC
54973-3169
Requested package NDC
54973-3169-1
11-digit product format
549733169
Labeler code
54973
Product ID
54973-3169_9277e2a2-d192-1355-e053-2a95a90aea41
Type
HUMAN OTC DRUG
Nonproprietary name
MATRICARIA CHAMOMILLA, ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, SULFUR, PULSATILLA VULGARIS and LYCOPODIUM CLAVATUM SPORE
Dosage form
TABLET
Route
ORAL
Labeler
Hyland's
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-04-15
Marketing end
0000-00-00
Substance
MATRICARIA CHAMOMILLA; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SULFUR
Active strength
30 [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage54973-316954973-3169-1DDiscontinued by firm2026-10-05

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 · 12 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…

Reported adverse events (FAERS/openFDA)#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54973-3169-1549733169011 BOTTLE, PLASTIC in 1 CARTON (54973-3169-1) > 40 g in 1 BOTTLE, PLASTIC2013-04-150000-00-00NoNoCurrent