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 |
|---|---|---|---|---|---|---|
| Severe Cold and Flu Daytime Honey | ACETAMINOPHEN, DEXTROMETHROPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger | 10b0fa3d-d6b2-272a-e063-6394a90a1205 | 2024-05-08 | Warnings | M012 |
| Childrens Plus Multi Symptom Cold | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Walgreens | dd967cfb-96b4-4cdc-82e2-a4838001c9e3 | 2024-05-08 | Warnings | M012 |
| Childrens Wal Tap Elixer Cold and Allergy | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Walgreens | 3f438f28-d1ad-44da-a573-f1b0824b051c | 2024-05-08 | Warnings | M012 |
| Cough Cold and Sore Throat Childrens | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreens | 400a0998-e276-4c8d-9b41-145b1b405fff | 2024-05-08 | Warnings | M012 |
| Mucus Congestion and Cough Relief Childrens | DEXTROMETHORPHAN HBR, GUAIFENSIN, PHENYLEPHRINE HCI | Walgreens | 19cd2409-d56b-4319-833c-eacc7dc498c1 | 2024-05-08 | Warnings | M012 |
| Severe Cold and Flu Nighttime Honey | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Kroger | 10b12f0e-dba7-fd71-e063-6294a90a42c1 | 2024-05-06 | Warnings | M012 |
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBRDOXYLAMINE SUCCINATE | Kroger | 10b15337-b9c5-4dc8-e063-6394a90ac056 | 2024-05-06 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Kroger | 1014da86-3a0e-136f-e063-6294a90ac931 | 2024-05-04 | Warnings | M012 |
| Robitussin Honey Maximum Strength Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | eaa10aed-5b1e-48bf-bc05-7a5638851daf | 2024-05-03 | Warnings | M012 |
| Theraflu-D Flu Relief Max Strength plus Nasal Decongestant | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCL | Haleon US Holdings LLC | e35cb719-9e7d-4b2b-81a4-29e147dd74fa | 2024-05-03 | Warnings | M012 |
| Theraflu-D Flu Relief Max Strength plus Nasal Decongestant Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCL | Haleon US Holdings LLC | 09e20842-2b75-43b9-ae5f-3515b35e655b | 2024-05-03 | Warnings | M012 |
| Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | Family Dollar (FAMILY WELLNESS) | f958d8ba-ede9-4b1a-8317-2404b68a9129 | 2024-05-03 | Warnings | M012 |
| Daytime Nighttime Cold and Flu Relief Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | WinCo Foods, LLC | fab57d70-ba54-416f-9f14-b64d2238ea16 | 2024-05-03 | Warnings | M012 |
| Tussin CF Non Drowsy Multi Symptom | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | WinCo Foods, LLC | 8ee27600-4f8e-406a-8ea3-eade691448f6 | 2024-05-03 | Warnings | M012 |
| SanaTos Children Cough and Congestion Cherry | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Pharmadel LLC | 60437d86-9e13-8d8a-e053-2991aa0a2317 | 2024-05-02 | Warnings | M012 |
| Robitussin Honey Maximum Strength Nighttime Cough DM | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | 0b41da13-18a1-4987-ae43-1319bfa27484 | 2024-05-01 | Warnings | M012 |
| 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 |
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 |