Home NDC 0280-0110-01 Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night
Product NDC 0280-0110
Requested package NDC 0280-0110-01
11-digit product format 002800110
Labeler code 0280
Product ID 0280-0110_47e3199f-608e-3107-e063-6294a90abdb1
Type HUMAN OTC DRUG
Nonproprietary name aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate
Dosage form KIT
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 0280-0110-01 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 0280-0110 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 68 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Equate SF Menthol Cough Drops MENTHOL WalMart 003a229c-b014-e9f3-e063-6294a90aa5ed 2025-12-23 Warnings Exact identifier application number: M012 Equate Menthol Cough Drops MENTHOL Walmart 124e6968-f59c-39d4-e063-6294a90a66d4 2025-12-23 Warnings Exact identifier application number: M012 Equate Severe Menthol Throat Drop MENTHOL Walmart 125f3f5a-52aa-e398-e063-6394a90a0012 2025-12-23 Warnings Exact identifier application number: M012 Equate Menthol Chewable Gels MENTHOL Walmart 1ba4b2be-7242-0a23-e063-6294a90af29c 2025-12-23 Warnings Exact identifier application number: M012 Walgreens Severe Menthol Throat Drops MENTHOL Walgreens 21dd3c68-cbc6-4799-e063-6394a90a6972 2025-12-23 Warnings Exact identifier application number: M012 cherry throat relief lozenges BENZOCAINE Zee Medical 499d0748-538f-678c-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 Guaiasorb DM DEXTROMETHORPHAN HBR, GUAIFENESIN NuCare Pharmaceuticals, Inc. 46a480c7-7092-b809-e063-6294a90a60cd 2025-12-23 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Winco Foods 360a6304-206d-5475-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Winco Foods 36342d8c-34ab-6178-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Winco Foods 37244333-1307-5121-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Winco foods 37718c73-880e-4a5c-e054-00144ff8d46c 2025-12-23 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Winco Foods 40676ddc-577f-5cc9-e054-00144ff88e88 2025-12-23 Warnings Exact identifier application number: M012 Sugar Free Menthol Cough Drops MENTHOL Winco Foods 3788e8b6-ab9e-1513-e054-00144ff88e88 2025-12-23 Warnings Exact identifier application number: M012 SAFETUSSIN Non Drowsy Cough plus chest congestion DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN KRAMER LABORATORIES eeca6370-29ea-4540-8139-e8461d58a286 2025-12-23 Warnings Exact identifier application number: M012 Tussin DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN Discount Drug Mart dd31f86b-f59e-459a-8e5f-176828706a4a 2025-12-23 Warnings Exact identifier application number: M012 Tussin CF DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE Discount Drug Mart f8e7a08e-7422-4a1b-bfec-93e0b50d10cd 2025-12-23 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL 25 MG Pioneer Life Sciences, LLC ab45ae97-7951-4058-e053-2995a90a7b2e 2025-12-23 Warnings Exact identifier application number: M012 Childrens Chest Congestion Relief Grape GUAIFENESIN Discount Drug Mart 3e5d245f-515c-4106-a855-fb97681b646a 2025-12-23 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL 25 MG Pioneer Life Sciences, LLC ab45ed16-86bb-3faf-e053-2995a90acfbc 2025-12-23 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL 25 MG Pioneer Life Sciences, LLC a7999da7-148a-4c6d-a2ea-0f4cc1d5b283 2025-12-23 Warnings Exact identifier application number: M012
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 0280-0110-01 00280011001 1 KIT in 1 CARTON (0280-0110-01) * 2 TABLET, EFFERVESCENT in 1 POUCH * 2 TABLET, EFFERVESCENT in 1 POUCH 1 kit 2021-08-05 No No Current