Home NDC 63083-9616-1 Middle Ear Drops
Product NDC 63083-9616
Requested package NDC 63083-9616-1
11-digit product format 630839616
Labeler code 63083
Product ID 63083-9616_4ef7b112-7147-43d1-85f9-ea25fd03af97
Type HUMAN OTC DRUG
Nonproprietary name Middle Ear Drops
Dosage form LIQUID
Route ORAL
Labeler Professional Complementary Health Formulas
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 1984-08-15
Substance SUS SCROFA EAR
Active strength 12 [hp_X]/29.5mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Additional Listing Data#
Finished product Yes
Brand name base Middle Ear Drops
Brand name suffix 9616
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SUS SCROFA EAR 12 [hp_X]/29.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7DX2J287CV Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# Effective, Related label table Effective Related label 2026-01-08 RERM 2026-01-08 RERM 2024-01-30 RERM 2024-01-30 RERM
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63083-9616-1 Middle Ear Drops9616 29.5 mL in 1 BOTTLE, DROPPER LIQUID 29.5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63083-9616 MIDDLE EAR DROPS 9616 (MIDDLE EAR DROPS) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS] 1 Current NDC, Legacy NDC, 1 package rows 20220211_2b8ff3ca-e52f-4855-938e-b264ad7d3334.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63083-9616-1 63083961601 29.5 mL in 1 BOTTLE, DROPPER (63083-9616-1) 29.5 ml 1985-08-15 0000-00-00 No No Current