Home NDC 0904-6464 robafen
Product NDC 0904-6464
11-digit product format 009046464
Labeler code 0904
Product ID 0904-6464_83295f24-f1cd-4c56-a593-b95a932b070a
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin
Dosage form SOLUTION
Route ORAL
Labeler Major Pharmaceuticals
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 1991-03-15
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 20 mg/10mL; mg/10mL
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 · 20 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 0904-6464-20 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 0904-6464-20 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 0904-6464-20 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 0904-6464-20 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 0904-6464-20 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 0904-6464-20 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 0904-6464-20 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 0904-6464-20 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 0904-6464-20 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 0904-6464-20 ad56d346431e…cc804d4bbf1e…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH ROBAFEN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MAJOR PHARMACEUTICALS] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ ROBAFEN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MAJOR PHARMACEUTICALS] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS ROBAFEN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MAJOR PHARMACEUTICALS] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ ROBAFEN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MAJOR PHARMACEUTICALS] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ROBAFEN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MAJOR PHARMACEUTICALS] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ROBAFEN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MAJOR PHARMACEUTICALS] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ROBAFEN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MAJOR PHARMACEUTICALS] 1 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S ROBAFEN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MAJOR PHARMACEUTICALS] 1 MENTHOL INACTIVE INGREDIENT L7T10EIP3A ROBAFEN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MAJOR PHARMACEUTICALS] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ROBAFEN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MAJOR PHARMACEUTICALS] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ROBAFEN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MAJOR PHARMACEUTICALS] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ROBAFEN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MAJOR PHARMACEUTICALS] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 ROBAFEN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MAJOR PHARMACEUTICALS] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ROBAFEN (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MAJOR PHARMACEUTICALS] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-6464-20 00904646420 1 BOTTLE in 1 CARTON (0904-6464-20) > 118 mL in 1 BOTTLE 1 bottle 1991-03-15 0000-00-00 No No Current