Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night
- Product NDC
- 0280-0109
- Requested package NDC
- 0280-0109-01
- 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#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fc60af2f-83cb-99ea-e053-6394a90a0b3b | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d7724692-1155-4cc8-a415-22f5fc4aec35 | Product name | 6 | 20220216 |
| bde672ba-4805-28d0-1986-73543d41b412 | Product name | 2 | 20210201 |
| d17a97fa-387f-690e-d2be-0083ab044a03 | Product name | 3 | 20170725 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| f212291f-05fe-9603-fc7e-bd73e38ce1e6 | Product name | 2 | 20161129 |
| ade821ba-260a-47e2-bd89-743e27ac9906 | Product name | 1 | 20161121 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| 9425d234-4ae1-4b53-adc6-8cc7af6dd657 | Product name | 1 | 20150929 |
| c6fba691-a132-4ede-95c6-f8c6bd696636 | Product name | 1 | 20150902 |
| c0200ab5-4954-454e-9676-30b741b245bd | Product name | 1 | 20150730 |
| 2a21311a-89e2-0e83-2ebd-117f9798b2b2 | Product name | 1 | 20140508 |
| 9007e8a7-ff50-f9b9-7945-f2a1deadd94e | Product name | 1 | 20140508 |
| 96c2be53-8e44-452d-56a2-d255b2f1af2d | Product name | 1 | 20140508 |
| bf8bd5f7-495f-4022-2780-7ded7ea7ea44 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| 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 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | 07c7c0d9-f063-4efc-8a08-2a1bfa9ca84a | 2024-05-01 | Warnings | M012 |
| Night Time Cold and Flu Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | dbfb8971-a122-4a97-a665-e3f0d494876e | 2024-05-01 | Warnings | M012 |
| Daytime Cold and Flu Non Drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | P & L Development, LLC | c08b150c-d821-466c-8521-f77535d6af1e | 2024-04-30 | Warnings | M012 |
| childrens allergy relief | DIPHENHYDRAMINE HYDROCHLORIDE | Walgreen Company | 7848bb09-2af8-47f6-b32d-96635a750a55 | 2024-04-29 | Warnings | M012 |
| NASAL and SINUS DECONGESTANT | PHENYLEPHRINE HYDROCHLORIDE | JHK Inc dba American Safety & First Aid | 63e51305-2575-49c4-9fda-7b3e1b4b6ede | 2024-04-26 | Warnings | M012 |
| Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Haleon US Holdings LLC | 7decc168-e847-4bbe-910b-26081469406f | 2024-04-26 | Warnings | M012 |
| Severe cold and flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI | P & L Development, LLC | 7c92bdcf-db1f-4299-982f-6a3da9cba6e6 | 2024-04-25 | Warnings | M012 |
| Severe cold and flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI | P & L Development, LLC | 15727e06-7bfc-424e-9e68-cc9cd5695bfd | 2024-04-25 | Warnings | M012 |
| Severe Cold and Flu Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | P & L Development, LLC | 5872fed8-862b-44a2-a06e-51ebf8618271 | 2024-04-25 | Warnings | M012 |
| CHERRY COUGH DROPS 50CT | MENTHOL, UNSPECIFIED FORM | JHK Inc dba American Safety & First Aid | 2f54b9c1-3a37-48fd-b964-6aa2631b8e62 | 2024-04-24 | Warnings | M012 |
| Dye Free Allergy childrens | DIPHENHYDRAMINE HYDROCHLORIDE | QUALITY CHOICE (Chain Drug Marketing Association) | f1a33c2f-2330-43f3-8026-de21808aec66 | 2024-04-22 | Warnings | M012 |
| Cold and Flu Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | fc7954a6-d061-4160-b1d1-a19eb9eabff4 | 2024-04-22 | Warnings | M012 |
| Dibromm Cold and Allergy Childrens | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | ea285d5a-9eb4-4f71-bb1b-4e24a8972819 | 2024-04-22 | Warnings | M012 |
| Childrens Allergy | DIPHENHYDRAMINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | c573da1e-c7ca-46e6-ad42-4ded2547afc3 | 2024-04-22 | Warnings | M012 |
| Cough Relief Cough Suppressant | DEXTROMETHORPHAN HBR | QUALITY CHOICE (Chain Drug Marketing Association) | 13ae4c67-a3fe-440c-91b8-c9412626c3cd | 2024-04-22 | Warnings | M012 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 47660794-22cc-4863-a183-e694d27e3543 | 2024-04-19 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | f9c08b18-a119-406b-bd96-73572b4445e2 | 2024-04-18 | Warnings | M012 |
| Nighttime Cough Relief | DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | e1fa0f51-6a68-4f6f-8988-0949d1942c2f | 2024-04-18 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | 025f6622-a6db-4a5c-aebd-5d54172fa4a1 | 2024-04-18 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | f9530d55-8226-4659-84f0-2c0b411572be | 2024-04-17 | Warnings | M012 |
DailyMed RxNorm Mappings#
| 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 | 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 |