FDA.reportPublic FDA data

RexallEar Relief Ear Drops

Product NDC
55910-107
11-digit product format
559100107
Labeler code
55910
Product ID
55910-107_2f388ec6-0ce0-f543-e063-6294a90a6e36
Type
HUMAN OTC DRUG
Nonproprietary name
MATRICARIA CHAMOMILLA, MERCURIUS SOLUBILIS, SULFUR
Dosage form
SOLUTION/ DROPS
Route
AURICULAR (OTIC)
Labeler
Dolgencorp LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-08-01
Substance
MATRICARIA CHAMOMILLA; 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
RexallEar Relief Ear Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MATRICARIA CHAMOMILLA10 [hp_X]/mL
MERCURIUS SOLUBILIS15 [hp_X]/mL
SULFUR12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG0R4UBI2ZZ, 324Y4038G2, 70FD1KFU70

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-107-07RexallEar Relief Ear Drops1 in 1 BOXSOLUTION/ DROPS13
55910-107-07RexallEar Relief Ear Drops12 mL in 1 BOTTLESOLUTION/ DROPS123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-107REXALLEAR RELIEF EAR DROPS (MATRICARIA CHAMOMILLA, MERCURIUS SOLUBILIS, SULFUR) SOLUTION/ DROPS [DOLGENCORP LLC]3Current NDC, Legacy NDC, 2 package rows20250303_59cfc7b4-faf0-4794-8911-d8745e12c6b8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-107-07559100107071 BOTTLE in 1 BOX (55910-107-07) / 12 mL in 1 BOTTLE1 bottle2015-08-010000-00-00NoNoCurrent