Home NDC 33992-0503-8 Cold Multi-Symptom
Product NDC 33992-0503
Requested package NDC 33992-0503-8
11-digit product format 339920503
Labeler code 33992
Product ID 33992-0503_c5a2f06e-43da-43cb-ab03-de3f550561c5
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Guaifenesin and Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler GREENBRIER INTERNATIONAL, INC.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2005-08-04
Marketing end 0000-00-00
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 2023-12-31
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 · 11 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…
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 COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [GREENBRIER INTERNATIONAL, INC.] 3 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [GREENBRIER INTERNATIONAL, INC.] 3 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [GREENBRIER INTERNATIONAL, INC.] 3 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [GREENBRIER INTERNATIONAL, INC.] 3 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [GREENBRIER INTERNATIONAL, INC.] 3 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [GREENBRIER INTERNATIONAL, INC.] 3 GUAIFENESIN ACTIVE MOIETY 495W7451VQ COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [GREENBRIER INTERNATIONAL, INC.] 3 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [GREENBRIER INTERNATIONAL, INC.] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [GREENBRIER INTERNATIONAL, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [GREENBRIER INTERNATIONAL, INC.] 3 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [GREENBRIER INTERNATIONAL, INC.] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [GREENBRIER INTERNATIONAL, INC.] 3 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [GREENBRIER INTERNATIONAL, INC.] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [GREENBRIER INTERNATIONAL, INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [GREENBRIER INTERNATIONAL, INC.] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [GREENBRIER INTERNATIONAL, INC.] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [GREENBRIER INTERNATIONAL, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP COLD MULTI-SYMPTOM SEVERE (ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [GREENBRIER INTERNATIONAL, INC.] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 33992-0503-8 33992050308 2 BLISTER PACK in 1 CARTON (33992-0503-8) > 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2005-08-04 0000-00-00 No No Current