Home NDC 58552-327 EXACTUSS TOTAL RELEASE
Product NDC 58552-327
11-digit product format 585520327
Labeler code 58552
Product ID 58552-327_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 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 58552-327 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 Marketing start Marketing end Sample Exclude flag Status 58552-327-01 58552032701 100 TABLET, FILM COATED in 1 BOTTLE (58552-327-01) 2011-05-27 0000-00-00 No No Current