Alka-Seltzer Plus Cold Medicine Sparkling Original
- Product NDC
- 0280-1400
- 11-digit product format
- 002801400
- Labeler code
- 0280
- Product ID
- 0280-1400_4526711d-1058-262c-e063-6294a90aef61
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ASPIRIN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE BITARTRATE
- Dosage form
- TABLET, EFFERVESCENT
- Route
- ORAL
- Labeler
- Bayer HealthCare LLC.
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2008-04-10
- Substance
- ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE
- Active strength
- 325; 2; 7.8 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 | 0280-1400 | 0280-1400-12 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 0280-1400 | 0280-1400-20 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 0280-1400 | 0280-1400-36 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 0280-1400 | 0280-1400-48 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 0280-1400 | 0280-1400-72 | D | Discontinued by firm | 2026-10-15 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0280-1400-48 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0280-1400-20 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0280-1400-36 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0280-1400-12 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0280-1400-72 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0280-1400-72 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0280-1400-48 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0280-1400-12 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0280-1400-20 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0280-1400-36 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0280-1400-72 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0280-1400-48 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0280-1400-12 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0280-1400-20 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0280-1400-36 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0280-1400-72 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0280-1400-48 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0280-1400-12 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0280-1400-20 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0280-1400-36 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0280-1400-72 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0280-1400-48 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0280-1400-12 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0280-1400-20 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0280-1400-36 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0280-1400-72 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0280-1400-48 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0280-1400-12 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0280-1400-20 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0280-1400-36 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 0280-1400-72 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 0280-1400-48 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 0280-1400-12 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 0280-1400-20 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 0280-1400-36 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 0280-1400-72 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 0280-1400-48 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 0280-1400-12 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 0280-1400-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 0280-1400-36 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0280-1400-72 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0280-1400-48 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0280-1400-12 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0280-1400-20 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0280-1400-36 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 0280-1400-72 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 0280-1400-48 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 0280-1400-12 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 0280-1400-20 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 0280-1400-36 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 0280-1400-72 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 0280-1400-48 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 0280-1400-12 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 0280-1400-20 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 0280-1400-36 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 0280-1400-72 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 0280-1400-48 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 0280-1400-12 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 0280-1400-20 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 0280-1400-36 | 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 Cold Medicine Sparkling Original
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ASPIRIN | 325 mg/1 |
| CHLORPHENIRAMINE MALEATE | 2 mg/1 |
| PHENYLEPHRINE BITARTRATE | 7.8 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| R16CO5Y76E | Internal UNII lookup |
| V1Q0O9OJ9Z | Internal UNII lookup |
| 27O3Q5ML57 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1536840 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 78537dcf-b157-4b67-a8b2-5cb144815166 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-1400-12 | Alka-Seltzer Plus Cold Medicine Sparkling Original | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 9 | |
| 0280-1400-12 | Alka-Seltzer Plus Cold Medicine Sparkling Original | 6 in 1 CARTON | TABLET, EFFERVESCENT | 6 | 9 | |
| 0280-1400-20 | Alka-Seltzer Plus Cold Medicine Sparkling Original | 10 in 1 CARTON | TABLET, EFFERVESCENT | 10 | 9 | |
| 0280-1400-20 | Alka-Seltzer Plus Cold Medicine Sparkling Original | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 9 | |
| 0280-1400-32 | Alka-Seltzer Plus Cold Medicine Sparkling Original | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 9 | |
| 0280-1400-32 | Alka-Seltzer Plus Cold Medicine Sparkling Original | 16 in 1 CARTON | TABLET, EFFERVESCENT | 16 | 9 | |
| 0280-1400-36 | Alka-Seltzer Plus Cold Medicine Sparkling Original | 18 in 1 CARTON | TABLET, EFFERVESCENT | 18 | 9 | |
| 0280-1400-36 | Alka-Seltzer Plus Cold Medicine Sparkling Original | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 9 | |
| 0280-1400-48 | Alka-Seltzer Plus Cold Medicine Sparkling Original | 24 in 1 CARTON | TABLET, EFFERVESCENT | 24 | 9 | |
| 0280-1400-48 | Alka-Seltzer Plus Cold Medicine Sparkling Original | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 9 | |
| 0280-1400-72 | Alka-Seltzer Plus Cold Medicine Sparkling Original | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 9 | |
| 0280-1400-72 | Alka-Seltzer Plus Cold Medicine Sparkling Original | 36 in 1 CARTON | TABLET, EFFERVESCENT | 36 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0280-1400-36 | EA - Each | 0280-1400 | d9ce5ae8-6625-47f9-ad92-12f7edef8e05 | 1 | 2018-12-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0280-1400 | ALKA-SELTZER PLUS COLD MEDICINE SPARKLING ORIGINAL (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC.] | 8 | Current NDC, Legacy NDC, 12 package rows | 20231205_78537dcf-b157-4b67-a8b2-5cb144815166.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 |
|---|---|---|---|---|---|---|
| Aspirin | ASPIRIN | United Natural Foods, Inc. dba UNFI | 19c7f832-d7ec-4dcc-8aa4-f4cbf64c9ff6 | 2026-07-02 | Warnings | M013 |
| pain relief EXTRA STRENGTH | ACETAMINOPHEN | Meijer Distribution, Inc. | ae84eb7e-a70b-4311-b2dc-ad153047a516 | 2026-07-01 | Warnings | M013 |
| Aspirin 325 mg | ASPIRIN | Hi-Tech Nutraceuticals, LLC | b3426a9a-ea99-da30-e053-2995a90a1e4b | 2026-07-01 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Salado Sales, Inc. | ca21d576-be3c-495d-9dbd-ed514bf65da7 | 2026-07-01 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Meijer Distribution Inc | 4e08a7cb-3894-84c3-e063-6394a90a0b42 | 2026-06-30 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Wal-Mart Stores Inc | 9b1201af-c802-4e19-b192-bbbf34367db4 | 2026-06-30 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | P & L Development, LLC | fc841cba-8f4f-407b-97de-0422977515bd | 2026-06-30 | Warnings | M013 |
| Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | United Natural Foods, Inc. dba UNFI | b6ff2b34-51ee-41bc-8b7d-7520ade0bf36 | 2026-06-30 | Warnings | M013 |
| Medline | ASPIRIN | Medline Industries, LP | 4b0c569a-ed7a-e104-e063-6394a90a6d54 | 2026-06-29 | Warnings | M013 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | WALMART INC. | e50b3f60-b827-426c-8e78-8447c89130fe | 2026-06-29 | Warnings | M013 |
| Acetaminophen PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Chain Drug Marketing Association, Inc. | e58417f4-3575-4433-ac2e-b7bf9fe8ba10 | 2026-06-29 | Warnings | M013 |
| Dr Kids Pain and Fever | ACETAMINOPHEN | CalmCo LLC | 5534a784-a7b1-5599-e063-6294a90a7961 | 2026-06-27 | Warnings | M013 |
| TYLENOL Extra Strength | ACETAMINOPHEN | Select Consumer Group LLC | 529d3a51-a248-7c02-e063-6294a90a10ae | 2026-06-27 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Sportpharm LLC | 830ffcaa-7ff8-4732-bc84-6a8c5e78722d | 2026-06-25 | Warnings | M013 |
| Aspirin | ASPIRIN | Strategic Sourcing Services LLC | ea2ef485-429e-4c63-ba7b-0a6b32892ad2 | 2026-06-25 | Warnings | M013 |
| Aspirin | ASPIRIN | Chain Drug Marketing Association, Inc. | 055d8420-c189-4a9e-acdc-21627935c8eb | 2026-06-25 | Warnings | M013 |
| Aspirin | ASPIRIN | Topco Associates, LLC | 5f32cf74-dbea-496c-ba23-2040ea354f40 | 2026-06-25 | Warnings | M013 |
| Aspirin | ASPIRIN | Salado Sales, Inc. | cf3139a5-e36e-48e3-bb6c-e102b0cec555 | 2026-06-25 | Warnings | M013 |
| Pain Relief Aspirin | ASPIRIN | Rite Aid Corporation | bd69d3d2-5d38-47c6-98a6-124f7a43b8b0 | 2026-06-25 | Warnings | M013 |
| Aspirin Regular Strength | ASPIRIN | Walgreen Company | 0b27c0fd-7ea8-4588-9169-5ad4e8df77ef | 2026-06-25 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1536840 | aspirin 325 MG / chlorpheniramine maleate 2 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | PSN | 78537dcf-b157-4b67-a8b2-5cb144815166 | 9 |
| 1536840 | aspirin 325 MG / chlorpheniramine maleate 2 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SCD | 78537dcf-b157-4b67-a8b2-5cb144815166 | 9 |
| 1536840 | ASA 325 MG / Chlorpheniramine Maleate 2 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SY | 78537dcf-b157-4b67-a8b2-5cb144815166 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0280-1400-12 | 00280140012 | 2 in 1 POUCH | Historical | |||||
| 0280-1400-20 | 00280140020 | 10 in 1 CARTON | Historical | |||||
| 0280-1400-32 | 00280140032 | 16 POUCH in 1 CARTON (0280-1400-32) / 2 TABLET, EFFERVESCENT in 1 POUCH | 16 pouch | 2008-04-10 | 0000-00-00 | No | No | Current |
| 0280-1400-36 | 00280140036 | 18 in 1 CARTON | Historical | |||||
| 0280-1400-48 | 00280140048 | 24 in 1 CARTON | Historical | |||||
| 0280-1400-72 | 00280140072 | 2 in 1 POUCH | Historical |