Home NDC 66992-281-10 Entex T
Product NDC 66992-281
Requested package NDC 66992-281-10
11-digit product format 669920281
Labeler code 66992
Product ID 66992-281_8bb6bf21-342b-4b87-93a6-22f331a1bb89
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin and Pseudoephedrine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Wraser Llc
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2010-09-30
Marketing end 0000-00-00
Substance GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 375 mg/1; mg/1
NDC exclude flag No
Listing certified through 2022-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ ENTEX T (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [WRASER PHARMACEUTICALS, LLC] 3 PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N ENTEX T (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [WRASER PHARMACEUTICALS, LLC] 3 GUAIFENESIN ACTIVE MOIETY 495W7451VQ ENTEX T (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [WRASER PHARMACEUTICALS, LLC] 3 PSEUDOEPHEDRINE ACTIVE MOIETY 7CUC9DDI9F ENTEX T (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [WRASER PHARMACEUTICALS, LLC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ENTEX T (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [WRASER PHARMACEUTICALS, LLC] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ENTEX T (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [WRASER PHARMACEUTICALS, LLC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ENTEX T (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [WRASER PHARMACEUTICALS, LLC] 3 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X ENTEX T (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [WRASER PHARMACEUTICALS, LLC] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ENTEX T (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [WRASER PHARMACEUTICALS, LLC] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ENTEX T (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [WRASER PHARMACEUTICALS, LLC] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66992-281-10 66992028110 100 TABLET in 1 BOTTLE (66992-281-10) 100 tablet 2010-09-30 0000-00-00 No No Current