Home NDC 49580-0382-4 Tussin CF
Product NDC 49580-0382
Requested package NDC 49580-0382-4
11-digit product format 495800382
Labeler code 49580
Product ID 49580-0382_761b1ecb-4445-45e0-8cb2-59748c15d32c
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin, Phenylephrine
Dosage form LIQUID
Route ORAL
Labeler P & L Development, LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-04-30
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 49580-0382 49580-0382-4 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 49580-0382 49580-0382-4 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 TUSSIN CF MULTI SYMPTOM COLD ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [P & L DEVELOPMENT, LLC] 2 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ TUSSIN CF MULTI SYMPTOM COLD ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [P & L DEVELOPMENT, LLC] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ TUSSIN CF MULTI SYMPTOM COLD ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [P & L DEVELOPMENT, LLC] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS TUSSIN CF MULTI SYMPTOM COLD ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [P & L DEVELOPMENT, LLC] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ TUSSIN CF MULTI SYMPTOM COLD ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [P & L DEVELOPMENT, LLC] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV TUSSIN CF MULTI SYMPTOM COLD ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [P & L DEVELOPMENT, LLC] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL TUSSIN CF MULTI SYMPTOM COLD ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [P & L DEVELOPMENT, LLC] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TUSSIN CF MULTI SYMPTOM COLD ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [P & L DEVELOPMENT, LLC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TUSSIN CF MULTI SYMPTOM COLD ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [P & L DEVELOPMENT, LLC] 2 LACTIC ACID INACTIVE INGREDIENT 33X04XA5AT TUSSIN CF MULTI SYMPTOM COLD ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [P & L DEVELOPMENT, LLC] 2 MENTHOL, UNSPECIFIED FORM INACTIVE INGREDIENT L7T10EIP3A TUSSIN CF MULTI SYMPTOM COLD ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [P & L DEVELOPMENT, LLC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TUSSIN CF MULTI SYMPTOM COLD ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [P & L DEVELOPMENT, LLC] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU TUSSIN CF MULTI SYMPTOM COLD ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [P & L DEVELOPMENT, LLC] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R TUSSIN CF MULTI SYMPTOM COLD ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [P & L DEVELOPMENT, LLC] 2 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 TUSSIN CF MULTI SYMPTOM COLD ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [P & L DEVELOPMENT, LLC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R TUSSIN CF MULTI SYMPTOM COLD ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [P & L DEVELOPMENT, LLC] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 49580-0382-4 49580038204 1 BOTTLE, PLASTIC in 1 BOX (49580-0382-4) > 118 mL in 1 BOTTLE, PLASTIC 2015-04-30 0000-00-00 No No Current