Home NDC 50804-174-02 Pressure Plus Pain PE Plus Cold
Product NDC 50804-174
Requested package NDC 50804-174-02
11-digit product format 508040174
Labeler code 50804
Product ID 50804-174_e8b84b46-f031-34cb-e053-2995a90aab2d
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form TABLET, COATED
Route ORAL
Labeler GoodSense
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-12-01
Marketing end 2024-06-30
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], 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 · 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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D PRESSURE PLUS PAIN PE PLUS COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [GOODSENSE] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH PRESSURE PLUS PAIN PE PLUS COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [GOODSENSE] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ PRESSURE PLUS PAIN PE PLUS COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [GOODSENSE] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ PRESSURE PLUS PAIN PE PLUS COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [GOODSENSE] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D PRESSURE PLUS PAIN PE PLUS COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [GOODSENSE] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS PRESSURE PLUS PAIN PE PLUS COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [GOODSENSE] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ PRESSURE PLUS PAIN PE PLUS COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [GOODSENSE] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV PRESSURE PLUS PAIN PE PLUS COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [GOODSENSE] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PRESSURE PLUS PAIN PE PLUS COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [GOODSENSE] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PRESSURE PLUS PAIN PE PLUS COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [GOODSENSE] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK PRESSURE PLUS PAIN PE PLUS COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [GOODSENSE] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PRESSURE PLUS PAIN PE PLUS COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [GOODSENSE] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PRESSURE PLUS PAIN PE PLUS COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [GOODSENSE] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D PRESSURE PLUS PAIN PE PLUS COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [GOODSENSE] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PRESSURE PLUS PAIN PE PLUS COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [GOODSENSE] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 PRESSURE PLUS PAIN PE PLUS COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [GOODSENSE] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E PRESSURE PLUS PAIN PE PLUS COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [GOODSENSE] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PRESSURE PLUS PAIN PE PLUS COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [GOODSENSE] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PRESSURE PLUS PAIN PE PLUS COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [GOODSENSE] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PRESSURE PLUS PAIN PE PLUS COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [GOODSENSE] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U PRESSURE PLUS PAIN PE PLUS COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [GOODSENSE] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PRESSURE PLUS PAIN PE PLUS COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [GOODSENSE] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50804-174-02 50804017402 2 BLISTER PACK in 1 CARTON (50804-174-02) > 12 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2014-12-01 2024-06-30 No No Current