Home NDC 67510-0062 Redness reliever
Product NDC 67510-0062
11-digit product format 675100062
Labeler code 67510
Product ID 67510-0062_aa6b98a9-a052-605c-e053-2995a90abe9c
Type HUMAN OTC DRUG
Nonproprietary name tetrahydrozoline HCl
Dosage form LIQUID
Route OPHTHALMIC
Labeler Kareway Product, Inc.
Application part349
Marketing category OTC MONOGRAPH FINAL
Marketing start 2011-08-11
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 67510-0062-5 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 67510-0062-5 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TETRAHYDROZOLINE HYDROCHLORIDE ACTIVE INGREDIENT 0YZT43HS7D REDNESS RELIEVER (TETRAHYDROZOLINE HCL) LIQUID [KAREWAY PRODUCT, INC.] 1 TETRAHYDROZOLINE ACTIVE MOIETY S9U025Y077 REDNESS RELIEVER (TETRAHYDROZOLINE HCL) LIQUID [KAREWAY PRODUCT, INC.] 1 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 REDNESS RELIEVER (TETRAHYDROZOLINE HCL) LIQUID [KAREWAY PRODUCT, INC.] 1 BORIC ACID INACTIVE INGREDIENT R57ZHV85D4 REDNESS RELIEVER (TETRAHYDROZOLINE HCL) LIQUID [KAREWAY PRODUCT, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K REDNESS RELIEVER (TETRAHYDROZOLINE HCL) LIQUID [KAREWAY PRODUCT, INC.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB REDNESS RELIEVER (TETRAHYDROZOLINE HCL) LIQUID [KAREWAY PRODUCT, INC.] 1 SODIUM BORATE INACTIVE INGREDIENT 91MBZ8H3QO REDNESS RELIEVER (TETRAHYDROZOLINE HCL) LIQUID [KAREWAY PRODUCT, INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X REDNESS RELIEVER (TETRAHYDROZOLINE HCL) LIQUID [KAREWAY PRODUCT, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R REDNESS RELIEVER (TETRAHYDROZOLINE HCL) LIQUID [KAREWAY PRODUCT, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67510-0062-5 67510006205 1 BOTTLE in 1 BOX (67510-0062-5) > 15 mL in 1 BOTTLE 1 bottle 2011-08-11 0000-00-00 No No Current