Home NDC 55319-382-04 Multi Symptom Cold CF
Product NDC 55319-382
Requested package NDC 55319-382-04
11-digit product format 553190382
Labeler code 55319
Product ID 55319-382_15155bbc-5f50-4baa-b206-167f87d2e82b
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin, Phenylephrine
Dosage form LIQUID
Route ORAL
Labeler Family Dollar (FAMILY WELLNESS)
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-03-31
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 · 3 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 2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 55319-382 55319-382-04 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 55319-382 55319-382-04 I Inactivated by FDA excluded / ndc_excluded.zip 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 55319-382 55319-382-04 I Inactivated by FDA excluded / ndc_excluded.zip bd6a592717d7…303034d00443…
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 MULTI SYMPTOM COLD CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ MULTI SYMPTOM COLD CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ MULTI SYMPTOM COLD CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS MULTI SYMPTOM COLD CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ MULTI SYMPTOM COLD CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV MULTI SYMPTOM COLD CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL MULTI SYMPTOM COLD CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA MULTI SYMPTOM COLD CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX MULTI SYMPTOM COLD CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 LACTIC ACID INACTIVE INGREDIENT 33X04XA5AT MULTI SYMPTOM COLD CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 MENTHOL, UNSPECIFIED FORM INACTIVE INGREDIENT L7T10EIP3A MULTI SYMPTOM COLD CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 MULTI SYMPTOM COLD CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU MULTI SYMPTOM COLD CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R MULTI SYMPTOM COLD CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 MULTI SYMPTOM COLD CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 WATER INACTIVE INGREDIENT 059QF0KO0R MULTI SYMPTOM COLD CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-382 MULTI SYMPTOM COLD CF ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 4 Legacy NDC 20230131_bdf05932-9ff4-41ec-92e1-55b3ffc4a3cc.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55319-382-04 55319038204 1 BOTTLE, PLASTIC in 1 BOX (55319-382-04) > 118 mL in 1 BOTTLE, PLASTIC 2015-03-31 0000-00-00 No No Current