Ear/Eye/Sinus Drops

Product NDC
63083-5004
Requested package NDC
63083-5004-2
11-digit product format
630835004
Labeler code
63083
Product ID
63083-5004_dfe75d35-3018-4775-beeb-ee28ac3a8bc7
Type
HUMAN OTC DRUG
Nonproprietary name
Ear/Eye/Sinus Drops
Dosage form
LIQUID
Route
ORAL
Labeler
Professional Complementary Health Formulas
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1984-08-15
Substance
BILBERRY; BOS TAURUS EYE; GINGER; GRAPHITE; POTASSIUM IODIDE; SINUSITISINUM; SUS SCROFA EAR
Active strength
2; 6; 3; 12; 6; 6; 6 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
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 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…

Additional Listing Data#

Finished product
Yes
Brand name base
Ear/Eye/Sinus Drops
Brand name suffix
5004
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BILBERRY2 [hp_X]/59mL
GINGER6 [hp_X]/59mL
SUS SCROFA EAR3 [hp_X]/59mL
BOS TAURUS EYE12 [hp_X]/59mL
SINUSITISINUM6 [hp_X]/59mL
POTASSIUM IODIDE6 [hp_X]/59mL
GRAPHITE6 [hp_X]/59mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9P2U39H18WInternal UNII lookup
C5529G5JPQInternal UNII lookup
7DX2J287CVInternal UNII lookup
VTW461N43PInternal UNII lookup
B575563DM5Internal UNII lookup
1C4QK22F9JInternal UNII lookup
4QQN74LH4OInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495edc6c-eac6-4fa5-a1ff-2f5f3c865064Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2026-01-09HEESD
2026-01-09HEESD
2024-01-30HEESD
2024-01-30HEESD

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-5004-2Ear/Eye/Sinus Drops500459 mL in 1 BOTTLE, DROPPERLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-5004EAR/EYE/SINUS DROPS 5004 (EAR/EYE/SINUS DROPS) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Current NDC, Legacy NDC, 1 package rows20220211_495edc6c-eac6-4fa5-a1ff-2f5f3c865064.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ear/Eye/Sinus Drops 5004EAR/EYE/SINUS DROPSProfessional Complementary Health Formulas495edc6c-eac6-4fa5-a1ff-2f5f3c8650642026-01-08WarningsExact identifier
ndc (package): 63083-5004-2
ndc (product): 63083-5004
ndc11 (package): 63083500402

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63083-5004-26308350040259 mL in 1 BOTTLE, DROPPER (63083-5004-2) 59 ml1985-08-150000-00-00NoNoCurrent