Home NDC 41163-512-02 Pressure and Pain PE Plus Mucus
Product NDC 41163-512
Requested package NDC 41163-512-02
11-digit product format 411630512
Labeler code 41163
Product ID 41163-512_e8b85171-dc32-3b61-e053-2a95a90a6bb2
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form TABLET, COATED
Route ORAL
Labeler Supervalu Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-08-01
Marketing end 2024-12-31
Substance ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
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 · 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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D PRESSURE AND PAIN PE PLUS MUCUS (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SUPERVALU INC.] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ PRESSURE AND PAIN PE PLUS MUCUS (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SUPERVALU INC.] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ PRESSURE AND PAIN PE PLUS MUCUS (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SUPERVALU INC.] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D PRESSURE AND PAIN PE PLUS MUCUS (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SUPERVALU INC.] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ PRESSURE AND PAIN PE PLUS MUCUS (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SUPERVALU INC.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV PRESSURE AND PAIN PE PLUS MUCUS (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SUPERVALU INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PRESSURE AND PAIN PE PLUS MUCUS (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SUPERVALU INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PRESSURE AND PAIN PE PLUS MUCUS (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SUPERVALU INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK PRESSURE AND PAIN PE PLUS MUCUS (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SUPERVALU INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PRESSURE AND PAIN PE PLUS MUCUS (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SUPERVALU INC.] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D PRESSURE AND PAIN PE PLUS MUCUS (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SUPERVALU INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PRESSURE AND PAIN PE PLUS MUCUS (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SUPERVALU INC.] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 PRESSURE AND PAIN PE PLUS MUCUS (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SUPERVALU INC.] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E PRESSURE AND PAIN PE PLUS MUCUS (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SUPERVALU INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PRESSURE AND PAIN PE PLUS MUCUS (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SUPERVALU INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PRESSURE AND PAIN PE PLUS MUCUS (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SUPERVALU INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PRESSURE AND PAIN PE PLUS MUCUS (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SUPERVALU INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U PRESSURE AND PAIN PE PLUS MUCUS (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SUPERVALU INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PRESSURE AND PAIN PE PLUS MUCUS (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SUPERVALU 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 41163-512-02 41163051202 2 BLISTER PACK in 1 CARTON (41163-512-02) > 12 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2014-08-01 2024-12-31 No No Current