Home NDC 51645-291-24 SINE OFF
Product NDC 51645-291
Requested package NDC 51645-291-24
11-digit product format 516450291
Labeler code 51645
Product ID 51645-291_e8f7ad44-09a9-f702-e053-2a95a90a5654
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Gemini Pharmaceuticals, Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2010-07-05
Marketing end 2022-10-31
Substance ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 500 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 SINE OFF SINUS/COLD MEDICINE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC.] 1 CHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT V1Q0O9OJ9Z SINE OFF SINUS/COLD MEDICINE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC.] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ SINE OFF SINUS/COLD MEDICINE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC.] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D SINE OFF SINUS/COLD MEDICINE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC.] 1 CHLORPHENIRAMINE ACTIVE MOIETY 3U6IO1965U SINE OFF SINUS/COLD MEDICINE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV SINE OFF SINUS/COLD MEDICINE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SINE OFF SINUS/COLD MEDICINE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SINE OFF SINUS/COLD MEDICINE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK SINE OFF SINUS/COLD MEDICINE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G SINE OFF SINUS/COLD MEDICINE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 SINE OFF SINUS/COLD MEDICINE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC.] 1 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO SINE OFF SINUS/COLD MEDICINE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SINE OFF SINUS/COLD MEDICINE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E SINE OFF SINUS/COLD MEDICINE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 SINE OFF SINUS/COLD MEDICINE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SINE OFF SINUS/COLD MEDICINE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SINE OFF SINUS/COLD MEDICINE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SINE OFF SINUS/COLD MEDICINE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SINE OFF SINUS/COLD MEDICINE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, INC.] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 SINE OFF SINUS/COLD MEDICINE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [GEMINI PHARMACEUTICALS, 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 51645-291-24 51645029124 2 BLISTER PACK in 1 BOX (51645-291-24) > 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2010-07-05 2022-10-31 No No Current