Home NDC 49580-0297 Childrens Plus Cough and Runny Nose
Product NDC 49580-0297
11-digit product format 495800297
Labeler code 49580
Product ID 49580-0297_4a1132b7-def6-4d46-b1a9-fd65138826d6
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide
Dosage form SUSPENSION
Route ORAL
Labeler P & L Development, LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-06-30
Marketing end 0000-00-00
Substance ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 160 mg/5mL; mg/5mL; mg/5mL
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 · 4 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 49580-0297-4 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 49580-0297-4 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 ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D CHILDRENS PLUS COUGH AND RUNNY NOSE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [P & L DEVELOPMENT, LLC] 1 CHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT V1Q0O9OJ9Z CHILDRENS PLUS COUGH AND RUNNY NOSE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [P & L DEVELOPMENT, LLC] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH CHILDRENS PLUS COUGH AND RUNNY NOSE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [P & L DEVELOPMENT, LLC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D CHILDRENS PLUS COUGH AND RUNNY NOSE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [P & L DEVELOPMENT, LLC] 1 CHLORPHENIRAMINE ACTIVE MOIETY 3U6IO1965U CHILDRENS PLUS COUGH AND RUNNY NOSE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [P & L DEVELOPMENT, LLC] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS CHILDRENS PLUS COUGH AND RUNNY NOSE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [P & L DEVELOPMENT, LLC] 1 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 CHILDRENS PLUS COUGH AND RUNNY NOSE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [P & L DEVELOPMENT, LLC] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M CHILDRENS PLUS COUGH AND RUNNY NOSE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [P & L DEVELOPMENT, LLC] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CHILDRENS PLUS COUGH AND RUNNY NOSE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [P & L DEVELOPMENT, LLC] 1 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM INACTIVE INGREDIENT K679OBS311 CHILDRENS PLUS COUGH AND RUNNY NOSE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [P & L DEVELOPMENT, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CHILDRENS PLUS COUGH AND RUNNY NOSE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [P & L DEVELOPMENT, LLC] 1 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L CHILDRENS PLUS COUGH AND RUNNY NOSE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [P & L DEVELOPMENT, LLC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CHILDRENS PLUS COUGH AND RUNNY NOSE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [P & L DEVELOPMENT, LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CHILDRENS PLUS COUGH AND RUNNY NOSE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [P & L DEVELOPMENT, LLC] 1 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S CHILDRENS PLUS COUGH AND RUNNY NOSE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [P & L DEVELOPMENT, LLC] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CHILDRENS PLUS COUGH AND RUNNY NOSE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [P & L DEVELOPMENT, LLC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R CHILDRENS PLUS COUGH AND RUNNY NOSE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [P & L DEVELOPMENT, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CHILDRENS PLUS COUGH AND RUNNY NOSE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [P & L DEVELOPMENT, LLC] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CHILDRENS PLUS COUGH AND RUNNY NOSE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [P & L DEVELOPMENT, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49580-0297 CHILDRENS PLUS COUGH AND RUNNY NOSE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [P & L DEVELOPMENT, LLC] 6 Legacy NDC 20230225_892073c3-1ca2-40f5-9ce6-ec87fd926065.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 49580-0297-4 49580029704 1 BOTTLE, PLASTIC in 1 BOX (49580-0297-4) > 118 mL in 1 BOTTLE, PLASTIC 2015-06-30 0000-00-00 No No Current