Alka-Seltzer Plus Day Severe Cold Plus Flu
- Product NDC
- 0280-0921
- 11-digit product format
- 002800921
- Labeler code
- 0280
- Product ID
- 0280-0921_47e32f69-3232-a960-e063-6394a90a8590
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Bayer HealthCare LLC.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-04-17
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 500; 20; 400; 10 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0280-0921 | 0280-0921-06 | D | Discontinued by firm | 2026-10-21 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 Day Severe Cold Plus Flu
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 500 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/1 |
| GUAIFENESIN | 400 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1550968 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| cec51eab-cce3-4965-a14e-a46d953050c4 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-0921-06 | Alka-Seltzer Plus Day Severe Cold Plus Flu | 1 in 1 PACKET | POWDER, FOR SOLUTION | 1 | 11 | |
| 0280-0921-06 | Alka-Seltzer Plus Day Severe Cold Plus Flu | 6 in 1 CARTON | POWDER, FOR SOLUTION | 6 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0280-0921-06 | EA - Each | 0280-0921 | ebaf37ed-0c60-442b-bf4a-ddc1ebda33f1 | 1 | 2019-09-05 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0280-0921 | ALKA-SELTZER PLUS DAY SEVERE COLD PLUS FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240111_cec51eab-cce3-4965-a14e-a46d953050c4.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 |
|---|---|---|---|---|---|---|
| Antihistamine | DIPHENHYDRAMINE HCL | Gendose Pharmaceuticals, LLC | 847cdee8-410f-4ff3-9245-976ed6f4c776 | 2026-05-15 | Warnings | M012 |
| Antihistamine | DIPHENHYDRAMINE HCL | Gendose Pharmaceuticals, LLC | d3b2f300-d919-44cd-ab71-b74b5bdfd977 | 2026-05-15 | Warnings | M012 |
| ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER | ACETAMINOPHEN 325 MG AND DEXTROMETHORPHAN HBR 10 MG ORAL LIQUID DAY TIME KIDS | MEDWISE LIFESCIENCES INC. | 51d52ce4-98c4-2b9b-e063-6294a90ade44 | 2026-05-15 | Warnings | M012 |
| Curewell Tussin DM | DEXTROMETHORPHAN, GUAIFENESIN | RMT HEALTH LLC | 4fe9ad93-cdc4-b4df-e063-6294a90a90ae | 2026-05-15 | Warnings | M012 |
| CounterAct Cough Drops Orchard Cherry | MENTHOL | Melaleuca, Inc. | 6049842c-d763-4a91-a225-976ed74e1693 | 2026-05-15 | Warnings | M012 |
| CounterAct Cough Drops Honey Lemon | MENTHOL | Melaleuca, Inc. | 84ac3489-9d64-401f-ab78-715af4de5440 | 2026-05-15 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu and Congestion Maximum Strength Day Night Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 51e03b5b-b05a-07c1-e063-6394a90ab201 | 2026-05-15 | Warnings | M012 |
| Sinus Congestion and Pain Relief Non-Drowsy/Daytime | ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL | Rite Aid Corporation | 38d73a1e-ac78-4f67-9291-bb48ab80306e | 2026-05-15 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | WALMART INC. | 071615ba-f50a-4d2a-a358-43140bccce72 | 2026-05-14 | Warnings | M012 |
| Severe Cold and Flu Nighttime Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | HyVee Inc | d4bcfabb-a054-4f53-8dc9-d361a03558b8 | 2026-05-14 | Warnings | M012 |
| Cough and Chest Congestion DM Adult | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS Pharmacy | 4444c05a-eba6-4633-b86f-34f455699fa9 | 2026-05-14 | Warnings | M012 |
| Topcare Day Time Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Topco Associates LLC | a88e5b8e-e6dd-4a1c-9628-5861d3205bdb | 2026-05-14 | Warnings | M012 |
| equate daytime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | 69b24c67-cf4b-46d7-a44b-d1917cc876b1 | 2026-05-14 | Warnings | M012 |
| GILTUSS DIABETIC EX | GILTUSS DIABETIC EX | Gil Pharmaceutical Corp | ab7915e7-323a-4fe1-887a-a3bd3f0aac98 | 2026-05-13 | Warnings | M012 |
| Giltuss EX Maximum Strength Expectorant | GILTUSS EX MAXIMUM STRENGTH EXPECTORANT | Gil Pharmaceutical Corp | 950db1ca-6936-47f8-a112-e3594d4c922c | 2026-05-13 | Warnings | M012 |
| Giltuss EX Expectorant | GILTUSS EX EXPECTORANT | Gil Pharmaceutical Corp | 3b363fb9-c4d3-446f-927c-f705ffc715b5 | 2026-05-13 | Warnings | M012 |
| Giltuss HBP EX Expectorant | GILTUSS HBP EX EXPECTORANT | Gil Pharmaceutical Corp | 31bd6356-27cf-4188-8fd5-9cd9392021ca | 2026-05-13 | Warnings | M012 |
| Halls Honey Lemon | MENTHOL | Mondelez Global LLC | aec46410-ffb1-4db4-b232-82110c562f69 | 2026-05-13 | Warnings | M012 |
| Mucinex Fast-Max Chest Congestion Honey and Berry Flavor | GUAIFENESIN | Reckitt Benckiser LLC | 8ec74cf2-88f5-40be-87e2-b756ab841754 | 2026-05-13 | Warnings | M012 |
| Mucinex Fast-Max Cold and Flu | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | c16253d3-3824-458c-8840-e3a2fbe7682c | 2026-05-13 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1550968 | acetaminophen 500 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG Powder for Oral Solution | PSN | cec51eab-cce3-4965-a14e-a46d953050c4 | 11 |
| 1550968 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution | SCD | cec51eab-cce3-4965-a14e-a46d953050c4 | 11 |
| 1550968 | acetaminophen 500 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG Granules for Oral Solution | SY | cec51eab-cce3-4965-a14e-a46d953050c4 | 11 |
| 1550968 | APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Guaifenesin 400 MG / Phenylephrine Hydrochloride 10 MG Powder for Oral Solution | SY | cec51eab-cce3-4965-a14e-a46d953050c4 | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0280-0921-06 | 00280092106 | 6 PACKET in 1 CARTON (0280-0921-06) > 1 POWDER, FOR SOLUTION in 1 PACKET | 6 packet | 2014-04-17 | 0000-00-00 | No | No | Current |