Middle Ear Drops

Product NDC
63083-9616
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

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
IngredientStrength
SUS SCROFA EAR12 [hp_X]/29.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7DX2J287CV

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-9616-12026-01-08C16284748780-11030e365-2dc2-111a-e063-dadaa90a10e2RERM
63083-9616-12026-01-08C16284748780-11030e365-2dc2-111a-e063-dadaa90a10e2RERM
63083-9616-12024-01-30C16284748780-11030e365-2dc2-111a-e063-dadaa90a10e2RERM
63083-9616-12024-01-30C16284748780-11030e365-2dc2-111a-e063-dadaa90a10e2RERM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-9616-1Middle Ear Drops961629.5 mL in 1 BOTTLE, DROPPERLIQUID29.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-9616MIDDLE EAR DROPS 9616 (MIDDLE EAR DROPS) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Current NDC, Legacy NDC, 1 package rows20220211_2b8ff3ca-e52f-4855-938e-b264ad7d3334.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63083-9616-16308396160129.5 mL in 1 BOTTLE, DROPPER (63083-9616-1) 29.5 ml1985-08-150000-00-00NoNoCurrent