Home NDC 53163-107-02 Alticotron
Product NDC 53163-107
Requested package NDC 53163-107-02
11-digit product format 531630107
Labeler code 53163
Product ID 53163-107_80f5ea58-2833-47da-9e09-c1e56d2c994f
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form SOLUTION/ DROPS
Route ORAL
Labeler Alternative Pharmacal Corporation
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-03-01
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 5 mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2021-12-31
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 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
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 ALTICOTRON (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 2 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ ALTICOTRON (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ ALTICOTRON (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS ALTICOTRON (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ ALTICOTRON (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV ALTICOTRON (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ALTICOTRON (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ALTICOTRON (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ALTICOTRON (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ALTICOTRON (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ALTICOTRON (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ALTICOTRON (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 2 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 ALTICOTRON (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 2 WATER INACTIVE INGREDIENT 059QF0KO0R ALTICOTRON (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53163-107-02 53163010702 60 mL in 1 BOTTLE (53163-107-02) 60 ml 2015-03-01 0000-00-00 No No Current