Home NDC 0280-0068 Alka-Seltzer Plus Severe Cold Night PowerFast Fizz
Product NDC 0280-0068
11-digit product format 002800068
Labeler code 0280
Product ID 0280-0068_47e325dd-448e-6435-e063-6294a90ab200
Type HUMAN OTC DRUG
Nonproprietary name aspirin, doxylamine succinate, dextromethorphan hydrobromide, phenylephrine bitartrate
Dosage form TABLET, EFFERVESCENT
Route ORAL
Labeler Bayer HealthCare LLC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-07-12
Substance ASPIRIN; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE BITARTRATE
Active strength 325; 6.25; 10; 7.8 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Antihistamine [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine Receptor Antagonists [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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 Night PowerFast Fizz
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ASPIRIN 325 mg/1 DOXYLAMINE SUCCINATE 6.25 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 PHENYLEPHRINE BITARTRATE 7.8 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2565491 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 0280-0068-01 Alka-Seltzer Plus Severe Cold Night PowerFast Fizz 10 in 1 CARTON TABLET, EFFERVESCENT 10 4 0280-0068-01 Alka-Seltzer Plus Severe Cold Night PowerFast Fizz 2 in 1 POUCH TABLET, EFFERVESCENT 2 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0280-0068 ALKA-SELTZER PLUS SEVERE COLD NIGHT POWERFAST FIZZ (ASPIRIN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC.] 3 Current NDC, Legacy NDC, 2 package rows 20231205_c1fae6c7-bbac-1320-e053-2a95a90aac5a.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 130 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CVS Vapor Steam CAMPHOR (SYNTHETIC) CVS 49da2c40-afc5-5770-e054-00144ff88e88 2024-12-13 Warnings Exact identifier application number: M012 Kroger Daytime Cold and Flu Softgel ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE The Kroger Company e428dd83-c538-2a92-e053-2a95a90a0e16 2024-12-13 Warnings Exact identifier application number: M012 Kroger Nighttime Cold and Flu Softgel ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE The Kroger Company e46291c7-6f4d-46a2-e053-2a95a90a80a1 2024-12-13 Warnings Exact identifier application number: M012 Foster and Thrive Childrens Allergy Relief DIPHENHYDRAMINE HCL Strategic Sourcing Services LLC 7eaba464-5cdb-4bd4-b272-38fa108658d5 2024-12-13 Warnings Exact identifier application number: M012 SUDAFED OM Sinus Severe Original OXYMETAZOLINE HYDROCHLORIDE Kenvue Brands LLC 1d089074-3969-ce6e-e063-6294a90aa70c 2024-12-12 Warnings Exact identifier application number: M012 RIGHT REMEDIES Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE Strive Pharmaceuticals Inc b4fc014c-7c5f-46a4-bf13-57103b6fa018 2024-12-11 Warnings Exact identifier application number: M012 Diphenhydramine Hydrochloride 25mg DIPHENHYDRAMINE HYDROCHLORIDE 25MG Strive Pharmaceuticals Inc b440eb2e-4de9-2b65-e053-2995a90abda8 2024-12-11 Warnings Exact identifier application number: M012 Meijer Effervescent Cold Relief ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE Meijer Distribution Inc. 6933ca9d-a32d-d856-e053-2a91aa0a408e 2024-12-10 Warnings Exact identifier application number: M012 Effervescent Orange Cold Relief ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE Meijer Distribution Inc. 826b5c0d-7a75-bbf0-e053-2a91aa0aebd6 2024-12-10 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. 09141018-37ba-4c93-9051-1ed129c448c1 2024-12-10 Warnings Exact identifier application number: M012 Original Herb Cough Drops MENTHOL Ricola USA Inc. 6ac9d95b-f6b9-4515-b126-697f8f839612 2024-12-10 Warnings Exact identifier application number: M012 THE ORIGINAL NATURAL HERB COUGH DROPS MENTHOL Ricola USA Inc. 989d1529-2875-47bf-81df-65494d62be7a 2024-12-10 Warnings Exact identifier application number: M012 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. 82813342-2be2-4731-ae90-dbd5eed667a9 2024-12-10 Warnings Exact identifier application number: M012 MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. b640a5d2-a7fe-486d-a65f-e7c993f950d6 2024-12-10 Warnings Exact identifier application number: M012 Sugar Free Mountain Herb Cough Suppressant Throat Drops MENTHOL Ricola USA Inc. c3f3c062-55e5-43c1-a016-ee47a7b388a5 2024-12-10 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE SWISS CHERRY MENTHOL Ricola USA Inc. ee4733b5-6e5a-438a-97da-110f3ef6c809 2024-12-10 Warnings Exact identifier application number: M012 SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS MENTHOL Ricola USA Inc. f62fcc38-2d43-40b3-841f-c8eea9ebd1e1 2024-12-10 Warnings Exact identifier application number: M012 DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. 8a6db093-7e52-443f-8dd6-94867606fef8 2024-12-10 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE COOL PEPPERMINT MENTHOL Ricola USA Inc. 5885343e-4a6e-44f7-87a4-d52599156197 2024-12-10 Warnings Exact identifier application number: M012 EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT MENTHOL Ricola USA Inc. 0baf383c-886d-47ca-8a6d-221298c79446 2024-12-10 Warnings Exact identifier application number: M012
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 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 c2232241-6e57-1427-e053-2995a90a488a 5 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 c2232241-6e57-1427-e053-2995a90a488a 5 2565491 aspirin 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet PSN c2232241-6e57-1427-e053-2995a90a488a 5 1536498 aspirin 325 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet PSN c2232241-6e57-1427-e053-2995a90a488a 5 2565491 aspirin 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet SCD c2232241-6e57-1427-e053-2995a90a488a 5 1536498 aspirin 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet SCD c2232241-6e57-1427-e053-2995a90a488a 5 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 c2232241-6e57-1427-e053-2995a90a488a 5 2565491 ASA 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet SY c2232241-6e57-1427-e053-2995a90a488a 5 1536498 ASA 325 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet SY c2232241-6e57-1427-e053-2995a90a488a 5 2565491 aspirin 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet PSN c1fae6c7-bbac-1320-e053-2a95a90aac5a 4 2565491 aspirin 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet SCD c1fae6c7-bbac-1320-e053-2a95a90aac5a 4 2565491 ASA 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet SY c1fae6c7-bbac-1320-e053-2a95a90aac5a 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0280-0068-01 00280006801 10 POUCH in 1 CARTON (0280-0068-01) / 2 TABLET, EFFERVESCENT in 1 POUCH 10 pouch 2021-07-12 0000-00-00 No No Current