Ear/Eye/Sinus Drops

Product NDC
63083-5004
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

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
BOS TAURUS EYE6 [hp_X]/59mL
GINGER3 [hp_X]/59mL
GRAPHITE12 [hp_X]/59mL
POTASSIUM IODIDE6 [hp_X]/59mL
SINUSITISINUM6 [hp_X]/59mL
SUS SCROFA EAR6 [hp_X]/59mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9P2U39H18W, VTW461N43P, C5529G5JPQ, 4QQN74LH4O, 1C4QK22F9J, B575563DM5, 7DX2J287CV

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-5004-22026-01-09C16284748780-11030e365-1029-111a-e063-dadaa90a10e2HEESD
63083-5004-22026-01-09C16284748780-11030e365-1029-111a-e063-dadaa90a10e2HEESD
63083-5004-22024-01-30C16284748780-11030e365-1029-111a-e063-dadaa90a10e2HEESD
63083-5004-22024-01-30C16284748780-11030e365-1029-111a-e063-dadaa90a10e2HEESD

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

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