Home NDC 0280-0109 Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night
Product NDC 0280-0109
11-digit product format 002800109
Labeler code 0280
Product ID 0280-0109_47e3199f-608e-3107-e063-6294a90abdb1
Type HUMAN OTC DRUG
Nonproprietary name aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate
Dosage form KIT
Route ORAL
Labeler Bayer HealthCare LLC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-08-05
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1536498 Internal RxNorm lookup 1537029 Internal RxNorm lookup 2664074 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0280-0109-01 Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night 1 in 1 CARTON KIT 1 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-0109 ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ DAY AND NIGHT (ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE) KIT [BAYER HEALTHCARE LLC.] 10 Current NDC, 1 package rows 20241208_fc60af2f-83cb-99ea-e053-6394a90a0b3b.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 98 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2664074 {1 (aspirin 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) / 1 (aspirin 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) } Pack GPCK fc60af2f-83cb-99ea-e053-6394a90a0b3b 13 2664074 1 daytime (aspirin 325 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) / 1 nighttime (aspirin 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) Pack PSN fc60af2f-83cb-99ea-e053-6394a90a0b3b 13 1537029 aspirin 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet PSN fc60af2f-83cb-99ea-e053-6394a90a0b3b 13 1536498 aspirin 325 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet PSN fc60af2f-83cb-99ea-e053-6394a90a0b3b 13 1537029 aspirin 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet SCD fc60af2f-83cb-99ea-e053-6394a90a0b3b 13 1536498 aspirin 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet SCD fc60af2f-83cb-99ea-e053-6394a90a0b3b 13 2664074 1 daytime (aspirin 325 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) / 1 nighttime (aspirin 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) Pack SY fc60af2f-83cb-99ea-e053-6394a90a0b3b 13 1537029 ASA 325 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet SY fc60af2f-83cb-99ea-e053-6394a90a0b3b 13 1536498 ASA 325 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet SY fc60af2f-83cb-99ea-e053-6394a90a0b3b 13
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0280-0109-01 00280010901 1 KIT in 1 CARTON (0280-0109-01) * 2 TABLET, EFFERVESCENT in 1 POUCH * 2 TABLET, EFFERVESCENT in 1 POUCH 1 kit 2021-08-05 No No Current