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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct55910-107UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55910-10755910-107-07UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G0R4UBI2ZZInternal 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
59cfc7b4-faf0-4794-8911-d8745e12c6b8Available on FDA.report

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

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
RexallEar Relief Ear DropsMATRICARIA CHAMOMILLA, MERCURIUS SOLUBILIS, SULFURDolgencorp LLC59cfc7b4-faf0-4794-8911-d8745e12c6b82025-02-28WarningsExact identifier
ndc (product): 55910-107

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