Home NDC 52083-289-60 Tusicof
Product NDC 52083-289
Requested package NDC 52083-289-60
11-digit product format 520830289
Labeler code 52083
Product ID 52083-289_9f336526-25df-419b-9cc9-b08d7ab5f0f0
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin, phenylephrine HCL, Dextromethorphan
Dosage form TABLET, COATED
Route ORAL
Labeler Kramer Novis.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-07-18
Marketing end 0000-00-00
Substance GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 400 mg/1; mg/1; mg/1
NDC exclude flag No
Listing certified through 2020-12-31
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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52083-289-02 Tusicof 2 in 1 PACKET TABLET, COATED 2 3 52083-289-60 Tusicof 60 in 1 BOTTLE TABLET, COATED 60 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH TUSICOF (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN) TABLET, COATED [KRAMER NOVIS.] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ TUSICOF (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN) TABLET, COATED [KRAMER NOVIS.] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ TUSICOF (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN) TABLET, COATED [KRAMER NOVIS.] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS TUSICOF (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN) TABLET, COATED [KRAMER NOVIS.] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ TUSICOF (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN) TABLET, COATED [KRAMER NOVIS.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV TUSICOF (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN) TABLET, COATED [KRAMER NOVIS.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TUSICOF (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN) TABLET, COATED [KRAMER NOVIS.] 1 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE TUSICOF (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN) TABLET, COATED [KRAMER NOVIS.] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X TUSICOF (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN) TABLET, COATED [KRAMER NOVIS.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TUSICOF (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN) TABLET, COATED [KRAMER NOVIS.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 TUSICOF (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN) TABLET, COATED [KRAMER NOVIS.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TUSICOF (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN) TABLET, COATED [KRAMER NOVIS.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52083-289 TUSICOF (GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN) TABLET, COATED [KRAMER NOVIS.] 3 Legacy NDC, 2 package rows 20181227_e6391d61-36ea-4926-878c-6758f65caa7e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 52083-289-60 52083028960 60 TABLET, COATED in 1 BOTTLE (52083-289-60) 2012-07-18 0000-00-00 No No Current