Home NDC 57344-123-05 Acetaminophen, Phenylephrine Hydrochloride
Product NDC 57344-123
Requested package NDC 57344-123-05
11-digit product format 573440123
Labeler code 57344
Product ID 57344-123_d15617fb-6e32-f136-e053-2995a90ada1a
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE
Dosage form TABLET, COATED
Route ORAL
Labeler AAA Pharmaceutical, Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-04-30
Marketing end 2022-06-30
Substance ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/1; mg/1
NDC exclude flag No
Listing certified through 0000-00-00
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…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE (ACETAMINOPHEN AND 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 57344-123-05 57344012305 2 BLISTER PACK in 1 CARTON (57344-123-05) > 12 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2012-04-30 2022-06-30 No No Current