Premier Value Ear Relief Ear Drops

Product NDC
68016-377
Requested package NDC
68016-377-00
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 (package): 68016-377-00
ndc (product): 68016-377
ndc11 (package): 68016037700

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

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