FDA.reportPublic FDA data

Signature Care Eye Drops A.C.

Product NDC
21130-755
11-digit product format
211300755
Labeler code
21130
Product ID
21130-755_0cfa5f56-a6f2-c541-e063-6394a90a811a
Type
HUMAN OTC DRUG
Nonproprietary name
tetrahydrozoline HCl, zinc sulfate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Better Living Brands LLC
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-24
Substance
TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE
Active strength
.05; .25 g/100mL; g/100mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Signature Care Eye Drops A.C.
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRAHYDROZOLINE HYDROCHLORIDE.05 g/100mL
ZINC SULFATE.25 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0YZT43HS7D, 89DS0H96TB
Rxcui1043249

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-755-01Signature Care Eye Drops A.C.1 in 1 CARTONSOLUTION12
21130-755-01Signature Care Eye Drops A.C.15 mL in 1 BOTTLE, DROPPERSOLUTION152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-755SIGNATURE CARE EYE DROPS A.C. (TETRAHYDROZOLINE HCL, ZINC SULFATE) SOLUTION [BETTER LIVING BRANDS LLC]2Current NDC, 2 package rows20231221_f685aca4-93d0-26d9-e053-2995a90a6e51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionPSNf685aca4-93d0-26d9-e053-2995a90a6e512
1043249tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic SolutionSCDf685aca4-93d0-26d9-e053-2995a90a6e512
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionSYf685aca4-93d0-26d9-e053-2995a90a6e512
1043249Tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic SolutionSYf685aca4-93d0-26d9-e053-2995a90a6e512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
21130-755-01211300755011 BOTTLE, DROPPER in 1 CARTON (21130-755-01) / 15 mL in 1 BOTTLE, DROPPER2023-03-24NoNoHistorical