Home NDC 58552-317 GILTUSS TOTAL RELEASE
Product NDC 58552-317
11-digit product format 585520317
Labeler code 58552
Product ID 58552-317_c9d5b39b-b35a-3d82-e053-2995a90adb5f
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin, Dextromethorphan HBr, and Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Gil Pharmaceutical Corp
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2009-10-19
Marketing end 0000-00-00
Substance PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 10 mg/1; mg/1; mg/1
NDC exclude flag No
Listing certified through 2022-12-31
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 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 58552-317-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 58552-317-02 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 58552-317-01 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 58552-317-02 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 58552-317-01 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 58552-317-02 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 58552-317-01 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 58552-317-02 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 58552-317-01 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 58552-317-02 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 58552-317-01 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 58552-317-02 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 58552-317-01 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 58552-317-02 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 58552-317-01 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 58552-317-02 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58552-317-01 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58552-317-02 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 58552-317-01 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 58552-317-02 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 58552-317-01 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 58552-317-02 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 58552-317-01 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 58552-317-02 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 58552-317-02 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 58552-317-02 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 58552-317-02 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH GILTUSS TOTAL RELEASE (GUAIFENESIN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] 2 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ GILTUSS TOTAL RELEASE (GUAIFENESIN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ GILTUSS TOTAL RELEASE (GUAIFENESIN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS GILTUSS TOTAL RELEASE (GUAIFENESIN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ GILTUSS TOTAL RELEASE (GUAIFENESIN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV GILTUSS TOTAL RELEASE (GUAIFENESIN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] 2 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP GILTUSS TOTAL RELEASE (GUAIFENESIN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GILTUSS TOTAL RELEASE (GUAIFENESIN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 GILTUSS TOTAL RELEASE (GUAIFENESIN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] 2 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 GILTUSS TOTAL RELEASE (GUAIFENESIN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] 2 MAGNESIUM SILICATE INACTIVE INGREDIENT 9B9691B2N9 GILTUSS TOTAL RELEASE (GUAIFENESIN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GILTUSS TOTAL RELEASE (GUAIFENESIN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] 2 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D GILTUSS TOTAL RELEASE (GUAIFENESIN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] 2 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP GILTUSS TOTAL RELEASE (GUAIFENESIN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] 2 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X GILTUSS TOTAL RELEASE (GUAIFENESIN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 GILTUSS TOTAL RELEASE (GUAIFENESIN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J GILTUSS TOTAL RELEASE (GUAIFENESIN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP GILTUSS TOTAL RELEASE (GUAIFENESIN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GILTUSS TOTAL RELEASE (GUAIFENESIN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 GILTUSS TOTAL RELEASE (GUAIFENESIN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL) TABLET [GIL PHARMACEUTICAL CORP] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58552-317 GILTUSS TOTAL RELEASE (GUAIFENESIN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL) TABLET, FILM COATED EXACTUSS TOTAL RELEASE (GUAIFENESIN, DEXTROMETHORPHAN HBR, AND PHENYLEPHRINE HCL) TABLET, FILM COATED [GIL PHARMACEUTICAL CORP] 5 Legacy NDC 20210819_a854de22-2f90-48c9-8cde-98446f7958b9.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58552-317-02 58552031702 12 BLISTER PACK in 1 CARTON (58552-317-02) > 2 TABLET, FILM COATED in 1 BLISTER PACK 12 blister pack 2011-07-15 0000-00-00 Yes No Current