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 |
|---|---|---|---|---|---|---|
| Family Wellness Oxymetazoline Sinus Severe | OXYMETAZOLINE | FAMILY DOLLAR (Family Wellness) | 13237d31-c60a-49f8-9b96-4414cf766a08 | 2024-11-21 | Warnings | M012 |
| DayTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 5b55d1df-275b-40d8-bde3-fc43313b7eb3 | 2024-11-20 | Warnings | M012 |
| Halls Green Apple | MENTHOL | Mondelez Global LLC | 1bb8dcb2-c3a8-a64e-e063-6294a90ae4a2 | 2024-11-20 | Warnings | M012 |
| Halls Blueberry | MENTHOL | Mondelez Global LLC | 275a6935-ea44-486e-e063-6394a90ae19a | 2024-11-20 | Warnings | M012 |
| No Drip Nasal Mist | OXYMETAZOLINE SPRAY | Walgreens Company | 234bd567-4e3c-419f-a000-fdfc28cafc8b | 2024-11-20 | Warnings | M012 |
| NICE Assorted Cough Drops | MENTHOL | Leosons Overseas Corp | 96db0f37-41cc-1ebd-e053-2a95a90a3215 | 2024-11-19 | Warnings | M012 |
| Nice Cherry Cough Drops | MENTHOL | Leosons Overseas Corp | 98e52604-6e41-6408-e053-2995a90a6bc8 | 2024-11-19 | Warnings | M012 |
| NICE Citrus Cough Drops | MENTHOL | Leosons Overseas Corp | 96d9527d-9bf9-ce82-e053-2995a90aff0c | 2024-11-19 | Warnings | M012 |
| NICE Menthol Cough Drops | MENTHOL | Leosons Overseas Corp | 96d77897-475c-482c-e053-2995a90a2da4 | 2024-11-19 | Warnings | M012 |
| NICE Honey Lemon Cough Drops | MENTHOL | Leosons Overseas Corp | 96da2c9d-2d0d-6252-e053-2995a90ac338 | 2024-11-19 | Warnings | M012 |
| SanaTos Boost | DEXTROMETHORPHAN HBR | Pharmadel LLC | ae6a424f-f3f0-3f6c-e053-2995a90a972d | 2024-11-18 | Warnings | M012 |
| SanaTos Turbo Max Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Pharmadel LLC | d56a071c-a747-5397-e053-2995a90aad8b | 2024-11-18 | Warnings | M012 |
| cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | H E B | 404ef5f4-7b7b-4c08-b159-9175a91be132 | 2024-11-17 | Warnings | M012 |
| equaline childrens cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | a24021a0-ef68-4bce-ba53-d262d1025cc0 | 2024-11-17 | Warnings | M012 |
| Cold and Cough DM | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Publix Super Markets Inc | 4d5f93c1-7752-4948-ba58-c4385cfc24c8 | 2024-11-17 | Warnings | M012 |
| Good Sense Childrens Cold and Cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | L. Perrigo Company | 8a87104f-94a4-4585-afd5-d610eea32e39 | 2024-11-17 | Warnings | M012 |
| equate childrens cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Wal-Mart Stores Inc | c91e94f4-4c51-4fe7-ad2e-0b9dc58b51e4 | 2024-11-17 | Warnings | M012 |
| foster and thrive childrens allergy relief | DIPHENHYDRAMINE HYDROCHLORIDE | Strategic Sourcing Services LLC | 1eac715b-351c-4b47-8d1d-6e921813c1a4 | 2024-11-15 | Warnings | M012 |
| basic care daytime severe cold and flu nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | 298d2796-5ae5-4346-b6d2-2ced2dd29dc3 | 2024-11-15 | Warnings | M012 |
| dg health day time severe cold and flu relief night time severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Dolgencorp, LLC | f721b393-9ad5-4fc6-a2c5-bd89e58caf16 | 2024-11-15 | 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 |