Home NDC 0280-0086 Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night
Product NDC 0280-0086
11-digit product format 002800086
Labeler code 0280
Product ID 0280-0086_45264f80-a094-86cf-e063-6394a90acb95
Type HUMAN OTC DRUG
Nonproprietary name aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate
Dosage form KIT
Route ORAL
Labeler Bayer HealthCare LLC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-04-27
NDC exclude flag No
Listing certified through 2026-12-31
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 2026-12-31 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 2565491 Internal RxNorm lookup 2565492 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 0280-0086-01 Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night 1 in 1 CARTON KIT 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-0086 ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ DAY AND NIGHT (ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE) KIT [BAYER HEALTHCARE LLC.] 7 Current NDC, Legacy NDC, 1 package rows 20241208_d7711cd6-5058-548d-e053-2a95a90ac54d.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 2565492 {1 (aspirin 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 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 d7711cd6-5058-548d-e053-2a95a90ac54d 8 2565492 1 daytime (aspirin 325 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) / 1 nighttime (aspirin 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) Pack PSN d7711cd6-5058-548d-e053-2a95a90ac54d 8 2565491 aspirin 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet PSN d7711cd6-5058-548d-e053-2a95a90ac54d 8 1536498 aspirin 325 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet PSN d7711cd6-5058-548d-e053-2a95a90ac54d 8 2565491 aspirin 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet SCD d7711cd6-5058-548d-e053-2a95a90ac54d 8 1536498 aspirin 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet SCD d7711cd6-5058-548d-e053-2a95a90ac54d 8 2565492 1 daytime (aspirin 325 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) / 1 nighttime (aspirin 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet) Pack SY d7711cd6-5058-548d-e053-2a95a90ac54d 8 2565491 ASA 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet SY d7711cd6-5058-548d-e053-2a95a90ac54d 8 1536498 ASA 325 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet SY d7711cd6-5058-548d-e053-2a95a90ac54d 8
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0280-0086-01 00280008601 1 KIT in 1 CARTON (0280-0086-01) * 1 TABLET, EFFERVESCENT in 1 POUCH * 1 TABLET, EFFERVESCENT in 1 POUCH 1 kit 2022-04-29 0000-00-00 No No Current