FDA.reportPublic FDA data

Premier Value Ear Relief Ear Drops

Product NDC
68016-377
11-digit product format
680160377
Labeler code
68016
Product ID
68016-377_bbfef157-79e8-7305-e053-2995a90aa962
Type
HUMAN OTC DRUG
Nonproprietary name
CHAMOMILE, MERCURIUS SOLUBILIS, SULFUR
Dosage form
SOLUTION/ DROPS
Route
AURICULAR (OTIC)
Labeler
Chain Drug Consortium, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2005-10-01
Substance
CHAMOMILE; MERCURIUS SOLUBILIS; SULFUR
Active strength
10; 15; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Premier Value Ear Relief Ear Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHAMOMILE10 [hp_X]/mL
MERCURIUS SOLUBILIS15 [hp_X]/mL
SULFUR12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FGL3685T2XInternal UNII lookup
324Y4038G2Internal UNII lookup
70FD1KFU70Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b0db3da2-c180-4ff5-a8ee-4ec220798f64Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-377-00Premier Value Ear Relief Ear Drops1 in 1 BOXSOLUTION/ DROPS12
68016-377-00Premier Value Ear Relief Ear Drops12 mL in 1 BOTTLESOLUTION/ DROPS122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-377-00ML - Milliliter68016-377dc66c236-ff10-47dd-a3c7-b0e45ff08e4c12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-377PREMIER VALUE EAR RELIEF EAR DROPS (CHAMOMILE, MERCURIUS SOLUBILIS, SULFUR) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM, LLC]2Current NDC, Legacy NDC, 2 package rows20210224_b0db3da2-c180-4ff5-a8ee-4ec220798f64.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
Premier Value Ear Relief Ear DropsCHAMOMILE, MERCURIUS SOLUBILIS, SULFURChain Drug Consortium, LLCb0db3da2-c180-4ff5-a8ee-4ec220798f642021-02-23WarningsExact identifier
ndc (product): 68016-377

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-377-00680160377001 BOTTLE in 1 BOX (68016-377-00) / 12 mL in 1 BOTTLE1 bottle2005-10-010000-00-00NoNoCurrent