FDA.reportPublic FDA data

HEB Advanced Eye Drops

Product NDC
37808-786
11-digit product format
378080786
Labeler code
37808
Product ID
37808-786_0cfaa641-21fe-e11b-e063-6394a90a69f2
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
HEB Grocery Company, LP
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-19
Substance
DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE
Active strength
.1; 1; 1; .05 g/100mL; g/100mL; g/100mL; g/100mL
Pharmacologic classes
Increased Intravascular Volume [PE], Osmotic Activity [MoA], Plasma Volume Expander [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HEB Advanced Eye Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTRAN 70.1 g/100mL
POLYETHYLENE GLYCOL 4001 g/100mL
POVIDONE1 g/100mL
TETRAHYDROZOLINE HYDROCHLORIDE.05 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7SA290YK68, B697894SGQ, FZ989GH94E, 0YZT43HS7D
Rxcui996202

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-786-01HEB Advanced Eye Drops1 in 1 BOXSOLUTION/ DROPS12
37808-786-01HEB Advanced Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-786HEB ADVANCED EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [HEB GROCERY COMPANY, LP]2Current NDC, 2 package rows20231221_f76281d6-3aea-349b-e053-6394a90afca2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996202dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSNf76281d6-3aea-349b-e053-6394a90afca22
996202dextran 70 1 MG/ML / polyethylene glycol 400 10 MG/ML / povidone 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCDf76281d6-3aea-349b-e053-6394a90afca22
996202dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionSYf76281d6-3aea-349b-e053-6394a90afca22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
37808-786-01378080786011 BOTTLE, DROPPER in 1 BOX (37808-786-01) / 15 mL in 1 BOTTLE, DROPPER2023-03-19NoNoHistorical