Home NDC 37012-516-34 Tussin CF
Product NDC 37012-516
Requested package NDC 37012-516-34
11-digit product format 370120516
Labeler code 37012
Product ID 37012-516_48206886-2d40-46ea-b960-db175b45278f
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Shopko Stores Operating Co., LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-07-08
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 20 mg/10mL; mg/10mL; mg/10mL
NDC exclude flag No
Listing certified through 2020-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH TUSSIN CF COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 2 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ TUSSIN CF COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ TUSSIN CF COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS TUSSIN CF COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ TUSSIN CF COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV TUSSIN CF COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL TUSSIN CF COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K TUSSIN CF COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TUSSIN CF COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TUSSIN CF COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TUSSIN CF COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU TUSSIN CF COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR TUSSIN CF COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R TUSSIN CF COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 2 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 TUSSIN CF COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R TUSSIN CF COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 37012-516-34 37012051634 1 BOTTLE in 1 CARTON (37012-516-34) > 237 mL in 1 BOTTLE 1 bottle 2013-07-08 0000-00-00 No No Current