Home NDC 57344-131-03 Phenylephrine Hydrochloride
Product NDC 57344-131
Requested package NDC 57344-131-03
11-digit product format 573440131
Labeler code 57344
Product ID 57344-131_94e265d8-7fcb-2ee9-e053-2a95a90a4993
Type HUMAN OTC DRUG
Nonproprietary name PHENYLEPHRINE HYDROCHLORIDE
Dosage form TABLET, COATED
Route ORAL
Labeler AAA Pharmaceutical, Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-04-13
Marketing end 0000-00-00
Substance PHENYLEPHRINE HYDROCHLORIDE
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 2020-12-31
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 · 9 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…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED [AAA PHARMACEUTICAL, 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 57344-131-03 57344013103 2 BLISTER PACK in 1 CARTON (57344-131-03) > 18 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2012-04-13 0000-00-00 No No Current