Home NDC 67172-282-01 Equate Eye Drops
Product NDC 67172-282
Requested package NDC 67172-282-01
11-digit product format 671720282
Labeler code 67172
Product ID 67172-282_7569e54f-c70f-4394-a7ea-d8cb65d30fc4
Type HUMAN OTC DRUG
Nonproprietary name Tetrahyrozoline hydrochloride
Dosage form LIQUID
Route OPHTHALMIC
Labeler Prestige Brands Holdings, Inc.
Application part349
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-02-11
Marketing end 0000-00-00
Substance TETRAHYDROZOLINE HYDROCHLORIDE
Active strength 1 mg/mL
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record
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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 67172-282 67172-282-01 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67172-282-01 Equate Eye Drops 1 in 1 BOX LIQUID 1 7 67172-282-01 Equate Eye Drops 15 mL in 1 BOTTLE, DROPPER LIQUID 15 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67172-282 EQUATE EYE DROPS (TETRAHYROZOLINE HYDROCHLORIDE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.] 7 Legacy NDC, 2 package rows 20241113_7535168e-907b-4c34-9949-2d1ca6bfe08e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 67172-282-01 67172028201 1 BOTTLE, DROPPER in 1 BOX (67172-282-01) > 15 mL in 1 BOTTLE, DROPPER 2013-02-11 0000-00-00 No No Current