Home NDC 63083-2153-2 Otitis Media Drops
Product NDC 63083-2153
Requested package NDC 63083-2153-2
11-digit product format 630832153
Labeler code 63083
Product ID 63083-2153_01edc603-bccd-4047-a651-145796e5cf51
Type HUMAN OTC DRUG
Nonproprietary name Otitis Media Drops
Dosage form LIQUID
Route ORAL
Labeler Professional Complementary Health Formulas
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 1984-08-15
Substance OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA MONTANA WHOLE; ACONITUM NAPELLUS WHOLE; SUS SCROFA EAR; AMARYLLIS BELLADONNA WHOLE; TELLURIUM; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; MERCURY; STREPTOCOCCUS PNEUMONIAE; HAEMOPHILUS INFLUENZAE
Active strength 3; 4; 6; 6; 12; 12; 12; 30; 30; 30; 60 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Otitis Media Drops
Brand name suffix 2153
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OYSTER SHELL CALCIUM CARBONATE, CRUDE 3 [hp_X]/59mL PULSATILLA MONTANA WHOLE 4 [hp_X]/59mL ACONITUM NAPELLUS WHOLE 6 [hp_X]/59mL SUS SCROFA EAR 6 [hp_X]/59mL AMARYLLIS BELLADONNA WHOLE 12 [hp_X]/59mL TELLURIUM 12 [hp_X]/59mL FERROSOFERRIC PHOSPHATE 12 [hp_X]/59mL GELSEMIUM SEMPERVIRENS ROOT 30 [hp_X]/59mL MERCURY 30 [hp_X]/59mL STREPTOCOCCUS PNEUMONIAE 30 [hp_X]/59mL HAEMOPHILUS INFLUENZAE 60 [hp_X]/59mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 11 matching rows.
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 C153 2026-01-08 C153 2024-01-30 C153 2024-01-30 C153
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63083-2153-2 Otitis Media Drops2153 59 mL in 1 BOTTLE, DROPPER LIQUID 59 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63083-2153 OTITIS MEDIA DROPS 2153 (OTITIS MEDIA DROPS) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS] 1 Current NDC, Legacy NDC, 1 package rows 20220216_9e8b60e9-0bd7-4c6c-99fa-cb87a9c83172.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 63083-2153-2 63083215302 59 mL in 1 BOTTLE, DROPPER (63083-2153-2) 59 ml 1985-08-15 0000-00-00 No No Current