Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz
- Product NDC
- 67751-217
- 11-digit product format
- 677510217
- Labeler code
- 67751
- Product ID
- 67751-217_2395eed2-0bab-a839-e063-6394a90aded6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide
- Dosage form
- TABLET, EFFERVESCENT
- Route
- ORAL
- Labeler
- Navajo Manufacturing Company Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-06-01
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN
- Active strength
- 10; 2; 5; 250 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [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
- 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 and Flu PowerFast Fizz
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| CHLORPHENIRAMINE MALEATE | 2 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
| ACETAMINOPHEN | 250 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| V1Q0O9OJ9Z | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1536477 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f6068011-ad56-59b4-e053-2995a90ac016 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d17a97fa-387f-690e-d2be-0083ab044a03 | Product name | 3 | 20170725 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| c6fba691-a132-4ede-95c6-f8c6bd696636 | Product name | 1 | 20150902 |
| c0200ab5-4954-454e-9676-30b741b245bd | Product name | 1 | 20150730 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67751-217-01 | Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz | 1 in 1 CARTON | TABLET, EFFERVESCENT | 1 | 2 | |
| 67751-217-01 | Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz | 1 in 1 POUCH | TABLET, EFFERVESCENT | 1 | 2 | |
| 67751-217-02 | Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 2 | |
| 67751-217-02 | Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz | 1 in 1 CARTON | TABLET, EFFERVESCENT | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67751-217 | ALKA-SELTZER PLUS SEVERE COLD AND FLU POWERFAST FIZZ (CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EFFERVESCENT [NAVAJO MANUFACTURING COMPANY INC.] | 2 | Current NDC, 4 package rows | 20241004_f6068011-ad56-59b4-e053-2995a90ac016.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 |
|---|---|---|---|---|---|---|
| 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 |
| MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME | ACETAMINOPHEN 325 MG DEXTROMETHORPHAN HBR 10 MG PHENYLEPHRINE HCI 5 MG | RITE AID | c92dbbbb-d149-1e7e-e053-2a95a90a6f1a | 2024-04-17 | Warnings | M012 |
| MULTI-SYMPTOM COLD AND FLU RELIEF NIGHTTIME | ACETAMINOPHEN 325 MG DEXTROMETHORPHAN HBR 15 MG DOXYLAMINE SUCCINATE 6.25 MG | RITE AID | c9323799-3505-d6c1-e053-2995a90a6f43 | 2024-04-17 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | fac8b01a-9666-43cc-a4ff-3f3ed452c7e4 | 2024-04-17 | Warnings | M012 |
| Daytime Nighttime Cold and Flu Relief Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | P & L Development, LLC | 15e9a336-1b34-4f00-9d1c-b945ddf17ed9 | 2024-04-16 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1536477 | acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Effervescent Oral Tablet | PSN | f6068011-ad56-59b4-e053-2995a90ac016 | 2 |
| 1536477 | acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Effervescent Oral Tablet | SCD | f6068011-ad56-59b4-e053-2995a90ac016 | 2 |
| 1536477 | APAP 250 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine Hydrochloride 5 MG Effervescent Oral Tablet | SY | f6068011-ad56-59b4-e053-2995a90ac016 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 67751-217-01 | 67751021701 | 1 POUCH in 1 CARTON (67751-217-01) / 1 TABLET, EFFERVESCENT in 1 POUCH | 1 pouch | 2022-06-01 | No | No | Current |
| 67751-217-02 | 67751021702 | 1 POUCH in 1 CARTON (67751-217-02) / 2 TABLET, EFFERVESCENT in 1 POUCH | 1 pouch | 2022-06-01 | No | No | Current |