FDA.reportPublic FDA data

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
IdentifierFDA.report destination
1536498Internal RxNorm lookup
2565491Internal RxNorm lookup
2565492Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d7711cd6-5058-548d-e053-2a95a90ac54dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0086-01Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night1 in 1 CARTONKIT18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-0086ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ DAY AND NIGHT (ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE) KIT [BAYER HEALTHCARE LLC.]7Current NDC, Legacy NDC, 1 package rows20241208_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 169 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Sinus Relief MistOXYMETAZOLINE SPRAYWalgreens Company847f47d9-62b1-49a3-8bb3-9bf275685bd22024-02-14WarningsExact identifier
application number: M012
Allergy Sinus, Lil Drug StoreACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATELil' Drug Store Products, Inc.1145440e-b37a-6e5e-e063-6294a90ab4a02024-02-13WarningsExact identifier
application number: M012
Guaifenesin and Codeine PhosphateGUAIFENESIN AND CODEINE PHOSPHATEA-S Medication Solutions36140639-e7a8-43bc-83e2-469430af9d1a2024-02-13WarningsExact identifier
application number: M012
Theraflu ExpressMax Daytime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLCff48b55a-0d32-47d6-941d-d99c7cf52f942024-02-12WarningsExact identifier
application number: M012
Childrens Robitussin Cough and Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINHaleon US Holdings LLC15950273-14c9-4a0b-bbb4-683048add7222024-02-08WarningsExact identifier
application number: M012
THERAFLU Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLC7d902237-a990-4c5e-875b-291e124e143b2024-02-03WarningsExact identifier
application number: M012
Tussin Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINBest Choice (Valu Merchandisers Company)0f2d371d-f890-41e5-ac11-db5559d324662024-02-02WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC4daca846-8511-4303-9e6c-9469f7f260ba2024-02-02WarningsExact identifier
application number: M012
CVS Health COUGH SUPPRESSANT SOFTGELDEXTROMETHORPHAN HYDROBROMIDECVS Pharmacy, Inc.f676dfeb-fba8-419d-8a47-c3880e4100cc2024-02-02WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReadyInCaseACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEP & L Development, LLC155a7168-b568-41f4-b8a2-214889b4eccf2024-02-02WarningsExact identifier
application number: M012
Vaporizing Chest Rub Lavender 4ozCAMPHOR/MENTHOLRejoice International Corp.104e1a38-3472-b9e2-e063-6294a90a38cf2024-02-01WarningsExact identifier
application number: M012
Vaporizing Chest Rub Lavender 4ozCAMPHOR/MENTHOLChina Ningbo Shangge Cosmetics Technology Corp.104f5b07-eed2-566c-e063-6294a90a65052024-02-01WarningsExact identifier
application number: M012
CHILDRENS COLD COUGH and SORE THROAT MIXED BERRYACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAptaPharma Inc.5962a73e-72e4-493b-94a7-43bc6cf9c82f2024-02-01WarningsExact identifier
application number: M012
good sense allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEL. Perrigo Company2cfa69b4-e33f-442a-a6df-b021b041da142024-02-01WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCLHaleon US Holdings LLCe5ef7b85-feee-44a7-bd0e-ed91352c74342024-01-31WarningsExact identifier
application number: M012
SEVERE CONGESTION and COUGH MAXDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAptaPharma Inc.17a07d2d-f2da-4e51-9a77-6f0c174987bb2024-01-31WarningsExact identifier
application number: M012
Maximum strength Max Cold and SinusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLAptaPharma Inc.263dae13-5f92-4505-8bcc-e903d05b9a0c2024-01-31WarningsExact identifier
application number: M012
THERAFLU POWERPODS NIGHTTIME SEVERE COLDACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC39f9feef-4bf2-4f10-9fff-22bbb1d8a4712024-01-30WarningsExact identifier
application number: M012
Theraflu Daytime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINEHaleon US Holdings LLCc0689223-5c90-4dbc-bbfa-f94e267504c32024-01-28WarningsExact identifier
application number: M012
THERAFLU MULTI-SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLCa4c56ca0-7785-404b-996d-137cc135f2702024-01-28WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL 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) } PackGPCKd7711cd6-5058-548d-e053-2a95a90ac54d8
25654921 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) PackPSNd7711cd6-5058-548d-e053-2a95a90ac54d8
2565491aspirin 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral TabletPSNd7711cd6-5058-548d-e053-2a95a90ac54d8
1536498aspirin 325 MG / dextromethorphan HBr 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral TabletPSNd7711cd6-5058-548d-e053-2a95a90ac54d8
2565491aspirin 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral TabletSCDd7711cd6-5058-548d-e053-2a95a90ac54d8
1536498aspirin 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral TabletSCDd7711cd6-5058-548d-e053-2a95a90ac54d8
25654921 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) PackSYd7711cd6-5058-548d-e053-2a95a90ac54d8
2565491ASA 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral TabletSYd7711cd6-5058-548d-e053-2a95a90ac54d8
1536498ASA 325 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral TabletSYd7711cd6-5058-548d-e053-2a95a90ac54d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0280-0086-01002800086011 KIT in 1 CARTON (0280-0086-01) * 1 TABLET, EFFERVESCENT in 1 POUCH * 1 TABLET, EFFERVESCENT in 1 POUCH1 kit2022-04-290000-00-00NoNoCurrent