Home NDC 0536-1068 Robafen Cough
Product NDC 0536-1068
11-digit product format 005361068
Labeler code 0536
Product ID 0536-1068_41f3d525-5f6a-4b3b-bf16-d5fb8efe9625
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Rugby Laboratories
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-03-01
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE
Active strength 15 mg/1
Pharmacologic classes Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0536-1068-34 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0536-1068-34 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0536-1068-34 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0536-1068-34 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0536-1068-34 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0536-1068-34 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0536-1068-34 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0536-1068-34 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0536-1068-34 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0536-1068-34 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0536-1068-34 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0536-1068-34 557ba5c1ecfa…9c80585c8c6e…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH ROBAFEN COUGH NON-DROWSY FORMULA (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS ROBAFEN COUGH NON-DROWSY FORMULA (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ROBAFEN COUGH NON-DROWSY FORMULA (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ROBAFEN COUGH NON-DROWSY FORMULA (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L ROBAFEN COUGH NON-DROWSY FORMULA (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ROBAFEN COUGH NON-DROWSY FORMULA (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP ROBAFEN COUGH NON-DROWSY FORMULA (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ROBAFEN COUGH NON-DROWSY FORMULA (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E ROBAFEN COUGH NON-DROWSY FORMULA (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ROBAFEN COUGH NON-DROWSY FORMULA (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R ROBAFEN COUGH NON-DROWSY FORMULA (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ROBAFEN COUGH NON-DROWSY FORMULA (DEXTROMETHORPHAN HBR) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0536-1068-34 00536106834 1 BOTTLE in 1 PACKAGE (0536-1068-34) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE 1 bottle 2015-03-01 0000-00-00 No No Current